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| ID | Type | Description | Link |
|---|---|---|---|
| Taiwan | Other Identifier | Taiwan : Food and Drug Administration | |
| South Korea | Other Identifier | Ministry of Food and Drugs Safety | |
| CTR20160507 | Other Identifier | China: Food and Drug Administration |
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Primary Objective
• To demonstrate the superiority of CHF 5993 pressurised metered dose inhaler (pMDI) over Symbicort® Turbuhaler® in terms of pulmonary function (change from baseline in pre-dose morning forced expiratory volume in the first second of a forced vital capacity manoeuvre [FEV1] and 2-hour post-dose morning FEV1 at Week 24).
Secondary Objectives
Key secondary objective:
• To demonstrate the superiority of CHF 5993 pMDI over Symbicort® Turbuhaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at Week 24) in the subgroup of Chinese population.
Other secondary objectives:
This was a phase III, 24-week, randomised, double-blind, double-dummy, Multinational (China, South Korea, Taiwan), Multicentre, 2-arm parallel-group, active-controlled study in patients with COPD.
The study was designed to demonstrate the superiority of CHF 5993 pMDI over budesonide/formoterol in terms of pulmonary function (change from baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at Week 24), both in the overall study population and in the Chinese population. The study lasted approximately 27 weeks for each patient, and a total of 7 clinic visits (Visit [V] 0 to V6) were performed during the study, plus a follow-up phone call.
A pre-screening visit (Visit [V] 0) was planned to occur no more than 7 days before a screening visit (V1, Week -2), followed by a 2-week open-label run-in period on Symbicort® Turbuhaler® (budesonide/formoterol fumarate [FF] 160/4.5 μg per inhalation), 2 inhalations twice daily (BID) (total daily dose: 640/18 μg budesonide/FF). The 2-week run-in period was deemed sufficient in order to 'standardise' the target population on the same treatment (Symbicort® Turbuhaler® [budesonide/FF 160/4.5 μg per inhalation]) prior to randomisation to study treatments, without leading to a deterioration in the disease.
At the randomisation visit (V2, Week 0), patients were randomised in a 1:1 ratio to one of the following two treatments for 24 weeks:
The length of the treatment period (24 weeks) was considered as adequate to evaluate the long-term efficacy and safety of CHF 5993 pMDI 100/6/12.5 μg versus (vs) budesonide/formoterol in terms of lung function.
Salbutamol was purchased locally by the vendor and used as rescue medication on an as-needed basis during both the run-in and treatment periods.
Four subsequent visits were performed after 4 weeks (V3), 12 weeks (V4), 18 weeks (V5), and 24 weeks (V6) of treatment. A time window of ±3 days was allowed for the visit dates from V2 to V6. An early termination (ET) visit was to be performed in the event of premature study discontinuation, during which all efforts were made to perform the assessments that should have been done at Week 24 (V6). A safety follow-up phone call was scheduled with the patient 7-10 days after last study treatment intake or ET visit in order to check the status of any unresolved adverse events (AEs) at the last visit.
Following the outbreak of the coronavirus disease-19 (COVID-19) pandemic the conduct of the study was adapted to ensure the safety of the patients and staff as well as the study continuity (see Section 9.8.1.2). Sites were instructed that patient retention was privileged with continuity of investigational drug supply. As emergency measures, it was authorised to postpone planned patients' visits or conduct remote visits and have the investigational product delivered to patients' home. Specific process for performing and reporting of Remote Visits was followed to cover all remote visits conducted during the period of the COVID-19 outbreak.
Study assessments
During the study, from screening (V1, Week -2) to end of treatment (V6, Week 24):
The final analysis included a total of 1053 screened patients and 708 randomised patients (353 patients received CHF 5993 pMDI and 355 patients received budesonide/formoterol). This included 826 patients screened in China of whom 578 patients were randomised to one of two treatments: CHF 5993 pMDI (288 patients) and budesonide/formoterol (290 patients). Overall there were 612 evaluable patients, including 506 evaluable patients in China. Of the 708 randomised patients, 706 patients were included in the Intention-to-treat (ITT) population (CHF 5993 pMDI: n=351; budesonide/formoterol: n=355).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF 5993 100/6/12.5 µg | Experimental | Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg (BDP/FF/GB), 2 inhalations bid, for a total daily dose of 400/24/50 μg BDP/FF/GB respectively, administered via pMDI. If patients were used to inhaling their pMDI COPD medications with a spacer device, the AeroChamber PlusTM was used with the study pMDI treatments, dispensed to the patients at V2 (Week 0) and V4 (Week 12). |
|
| Symbicort Turbuhaler 160/4.5 µg | Active Comparator | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF 5993 100/6/12.5 µg | Drug | Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pre-dose Forced Expiratory Volume Within the First Second (FEV1) at Week 24 | FEV1 measures the amount, or volume, exhaled by a patient in the first second of the expiration after a full inspiration. The lower the values, more severe the airflow limitation. For FEV1, the highest value from 3 technically acceptable attempts was recorded irrespective of the curve they were derived from. The chosen highest value had not to exceed the second highest by more than 150 mL; if the difference was larger, up to 8 measurements were performed and the largest value reported. Please note that the adjusted mean is reported with its 95%IC. | Week 24 (Visit 6) |
| Change From Baseline in 2-hour Post-dose FEV1 at Week 24 | FEV1 measures the amount, or volume, exhaled by a patient in the first second of the expiration after a full inspiration. The lower the values, more severe the airflow limitation. For FEV1, the highest value from 3 technically acceptable attempts was recorded irrespective of the curve they were derived from. The chosen highest value had not to exceed the second highest by more than 150 mL; if the difference was larger, up to 8 measurements were performed and the largest value reported. Please note that the adjusted mean is reported with its 95%IC. | Week 24 (Visit 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pre-dose Morning FEV1 at All the Other Clinic Visits | FEV1 measures the amount, or volume, exhaled by a patient in the first second of the expiration after a full inspiration. The lower the values, more severe the airflow limitation. For FEV1, the highest value from 3 technically acceptable attempts was recorded irrespective of the curve they were derived from. The chosen highest value had not to exceed the second highest by more than 150 mL; if the difference was larger, up to 8 measurements were performed and the largest value reported. Please note that the adjusted mean is reported with its 95%IC. |
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Inclusion criteria
Patients had to meet all of the following inclusion criteria to be eligible for enrolment into the study:
Male and female adults aged ≥ 40 years with written informed consent obtained prior to any study-related procedure;
Patients with a diagnosis of COPD (according to GOLD 2015 strategic document, updated January 2015) at least 12 months before the screening visit;
A smoking history of at least 10 pack years [pack years = (number of cigarettes per day x number of years)/20]. Current and ex-smokers were eligible; Note: Smoking cessation therapy had to be completed 6 months prior to screening visit.
A post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 at least 10-15 mins after 4 puffs (4 x 100 μg) of salbutamol pMDI;
A documented history of at least one exacerbation in the 12 months preceding the screening visit. COPD exacerbation was defined according to the following: "A sustained worsening of the patient's condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD that includes prescriptions of systemic corticosteroids and/or antibiotics or need for hospitalisation";
Patients under therapy for at least 2 months prior to screening with either:
A cooperative attitude and ability to be trained to use correctly the study treatment inhalers (pMDI and Turbuhaler®);
A cooperative attitude and ability to be trained to use correctly the COPD questionnaires.
All inclusion criteria were checked at screening (V1, Week -2). If criterion #4 was not met at V1, the test could be repeated once before the randomisation visit (V2, Week 0). Inclusion criteria #7 and #8 were to be re-checked at the randomisation visit (V2, Week 0).
Exclusion Criteria:
If a patient met any of the following criteria, he/she was not enrolled into the study:
Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use one or more of the following reliable methods of contraception:
Any postmenopausal women (physiologic menopause defined as "12 consecutive months of amenorrhea") or women permanently sterilised (e.g. tubal occlusion, hysterectomy or bilateral salpingectomy) could have been enrolled in the study;
Diagnosis of asthma, history of allergic rhinitis or atopy (atopy which may raise contra-indications or impact the efficacy of the study according to Investigator's judgement);
Patients requiring use of the following medications:
COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalisation during the run-in period;
Changes in dose, schedule, formulation or product of oral xanthine derivatives (e.g. theophylline) in the month prior to screening visit or during the run-in period. Stop of xanthines prior to screening visit was allowed;
Patients treated with non-cardioselective β-blockers in the week preceding the screening visit or during the run-in period;
Patients treated with long-acting antihistamines (e.g. astemizole, terfenadine) unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study, or if taken as required (PRN);
Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxaemia;
Known respiratory disorders other than COPD which may impact the efficacy of the study treatment according to the Investigator's judgement. This can include but is not limited to alfa-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease;
Patients who had a clinically significant (CS) cardiovascular condition (such as but not limited to unstable ischaemic heart disease, New York Heart Association (NYHA) Class III/IV, left ventricular failure, acute myocardial infarction), advanced atrio-ventricular conduction blocks;
Patients with atrial fibrillation (AF):
An abnormal and CS 12-lead ECG that results in an active medical problem which may impact the safety of the patient according to Investigator's judgement. Patients whose ECG (12 lead) showed Fridericia-corrected QT interval (QTcF) > 450 ms for males or QTcF > 470 ms for females at screening and at randomisation visits were not eligible.
Medical diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that in the opinion of the Investigator would prevent use of anticholinergic agents;
History of hypersensitivity to M3 antagonists, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial;
Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study treatment according to Investigator's judgement;
Patients with serum potassium levels < 3.5 mEq/L (or 3.5 mmol/L) at screening;
Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; uncontrolled gastrointestinal disease (e.g. active peptic ulcer); neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the feasibility of the results of the study according to Investigator's judgement;
History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit;
Participation in another clinical trial where investigation drug was received less than 8 weeks prior to screening visit;
Patients treated with Traditional Chinese Medicines used for respiratory diseases.
All exclusion criteria except for criterion #4 were checked at screening (V1, Week -2).
The following exclusion criteria were to be re-checked at the randomisation visit (V2, Week 0): #1,
#4, #5, #6, #7, #10, #11, #12, #17, and #20. For patients in South Korea (only), the following were added to the South Korea-specific protocol (version 3.0):
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| Name | Affiliation | Role |
|---|---|---|
| Jinping Zheng | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiesi clinical Trial Site 156031 | Beijing | Beijing Municipality | 100000 | China | ||
| Chiesi Clinical Trial Site 156026 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33757520 | Result | Zheng J, Baldi S, Zhao L, Li H, Lee KH, Singh D, Papi A, Grapin F, Guasconi A, Georges G. Efficacy and safety of single-inhaler extrafine triple therapy versus inhaled corticosteroid plus long-acting beta2 agonist in eastern Asian patients with COPD: the TRIVERSYTI randomised controlled trial. Respir Res. 2021 Mar 23;22(1):90. doi: 10.1186/s12931-021-01683-2. |
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A total of 708 patients were randomised to one of the two treatments:
Of the 708 randomised patients, 707 patients received at least one dose of study treatment. 318 patients completed the study with CHF 5993 pMDI, and 311 patients completed the study with budesonide/formoterol.
A total of 1053 patients were screened, including 826 patients from China, 177 patients from South Korea, and 50 patients from Taiwan.
Overall, 345 patients were screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | CHF 5993 100/6/12.5 µg | Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg (BDP/FF/GB), 2 inhalations bid, for a total daily dose of 400/24/50 μg BDP/FF/GB respectively, administered via pMDI. If patients were used to inhaling their pMDI COPD medications with a spacer device, the AeroChamber PlusTM was used with the study pMDI treatments, dispensed to the patients at V2 (Week 0) and V4 (Week 12). CHF 5993 100/6/12.5 µg: Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2019 | Feb 10, 2026 |
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| 160 µg budesonide + 4.5 µg formoterol fumarate | Drug | Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
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| Pre-dose morning at week 4 (visit 3), week 12 (visit 4), week 18 (visit 5), week 24 (visit 6) |
| Change From Baseline at 2-hour Post-dose FEV1 at All the Clinic Visits | FEV1 measures the amount, or volume, exhaled by a patient in the first second of the expiration after a full inspiration. The lower the values, more severe the airflow limitation. For FEV1, the highest value from 3 technically acceptable attempts was recorded irrespective of the curve they were derived from. The chosen highest value had not to exceed the second highest by more than 150 mL; if the difference was larger, up to 8 measurements were performed and the largest value reported. Please note that the adjusted mean is reported with its 95%IC. | 2-hour post-dose morning at week 0 (V2), week 4 (V3), week 12 (V4), week 18 (V5), week 24 (V6) |
| Change From Baseline in Pre-dose FEV1 ≥ 100 mL at Week 24 | FEV1 response is defined as a change from baseline in pre-dose morning FEV1 ≥ 100 mL. If the change from baseline is < 100 mL the patient is classified as a non-responder in terms of FEV1. Patients with missing pre-dose morning FEV1 value at the relevant time points were also be classified as non-responders. The number and percentage of FEV1 responders/non-responders (distinguishing also the two categories of non-responders: with a change from baseline actually < 100 mL or with missing data) at Visit 6 are presented by treatment group. | Week 24 (V6) |
| Changes From Pre-Dose to the 2-Hour Post-Dose Value of FEV1 at Each Visit From Visit 3 Onwards | The changes from pre-dose to the 2-hour post-dose morning FEV1 at each clinic visit from V3 onwards are presented by treatment in the ITT population. Please note that the adjusted mean is reported with its 95%IC. | Week 4 (V3), week 12 (V4), week 18 (V5), week 24 (V6) |
| Adjusted Rate Per Patient Per Year of Moderate or Severe COPD Exacerbations Over 24 Weeks of Treatment | Moderate or Severe COPD exacerbations during the randomised treatment period derived from the COPD exacerbations (E) eCRF form were considered for the analysis. Only E with start date ≥ date of start of randomised treatment period and ≤ date of end of randomised treatment period were considered. Please note that in the analysis, two COPD E were considered as a single episode if the 2nd E started less than 10 days:
| Over the 24-week treatment period |
| Time to First Moderate or Severe COPD Exacerbation Over 24 Weeks of Treatment | In patients with at least one moderate/severe COPD exacerbation, time to first moderate/severe COPD exacerbation was calculated as the time in weeks between the start date of randomised treatment period and the date at which the first COPD exacerbation occurs. Time to first moderate/severe COPD exacerbation (weeks) = (date of start of first moderate/severe COPD exacerbation - date of start of randomised treatment period)/7. Please note that the Rows don't represent mutually exclusive and exhaustive categories of the overall number of participants analyzed (N=351 for CHF 5993 and N=355 for Symbicort Turbuhaler). The number of exacerbation-free patients at the beginning of each study period is reported for each row (not the number of participants analyzed), with the relative cumulative number of patients with first moderate/severe exacerbation at the end of each study period (unit of measure). | From baseline to week 24 (EOT) |
| Change From Baseline in Pre-Dose Morning Forced Vital Capacity (FVC) at All Clinic Visits | FVC is defined as the total amount of air exhaled during the FEV test. Forced vital capacity, together with Forced Expiratory Volume, are lung function tests that are measured during spirometry. The lower the capacity, the worse the respiratory functionality. Change from Baseline in Pre-Dose Morning Forced Vital Capacity (FVC) at all clinic visits are presented by treatment in the ITT population. Please note that adjusted mean was reported with its 95%IC. | Pre-dose morning, week 4 (V3), week 12 (V4), week 18 (V5), week 24 (V6) |
| Change From Baseline in 2-Hour Post-Dose Morning FVC at All Clinic Visits | FVC is defined as the total amount of air exhaled during the FEV test. Forced vital capacity, together with Forced Expiratory Volume, are lung function tests that are measured during spirometry. The lower the capacity, the worse the respiratory functionality. Change from Baseline in 2-hour post-dose Forced Vital Capacity (FVC) at all clinic visits are presented by treatment in the ITT population. Please note that adjusted mean is reported with its 95%IC. | 2-hour post dose, week 4 (V3), week 12 (V4), week 18 (V5), week 24 (V6) |
| Change From Pre-Dose to the 2-Hour Post-Dose Value of FVC at Each Visit From Visit 3 Onwards | FVC is defined as the total amount of air exhaled during the FEV test. Forced vital capacity, together with Forced Expiratory Volume, are lung function tests that are measured during spirometry. The lower the capacity, the worse the respiratory functionality. Change from Pre-Dose to the 2-Hour Post-Dose Value of Forced Vital Capacity (FVC) at all clinic visits from V3 onwards are presented by treatment in the ITT population. Please note that adjusted mean is reported with its 95%IC. | From Pre-Dose to the 2-Hour Post-Dose at week 4 (V3), week 12 (V4), week 18 (V5) and week 24 (V6) |
| Pre-Dose FEV1/FVC at All Clinic Visits | The FEV1/FVC ratio, also called modified Tiffeneau-Pinelli index, is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease. The FEV1/FVC ratio is used to determine if the pattern is obstructive, restrictive, or normal. Chronic airflow limitation can be generally defined as fixed ratio of forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) < 0.70 after bronchodilation. So the lower the value, the worse the outcome and the pattern. Pre-dose FEV1/FVC at each visit was summarised by treatment group using descriptive statistics. | Pre-dose at baseline (V1), week 0 (V2), week 4 (V3), week 12 (V4), week 18 (V5), week 24 (V6) |
| Change From Baseline in Pre-dose Morning Forced Expiratory Flow Measured Between 25% and 75% of a Forced Vital Capacity (FEF25-75%) at All Clinic Visits | FEF25-75% is defined as "forced expiratory flow over the middle one-half of the FVC; the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled." A reduced FEF25-75% is thought to be a marker of small airway obstruction. Hence, the lower the parameter, the worse the status of airways. Among the various measurements collected during conventional spirometry, forced expiratory flow at 25% and 75% of the pulmonary volume (FEF25-75) measures the average flow rates of medium-to-small airways during the forced vital capacity (FVC) segment to testing and presents the status of those airways in patients. The changes from baseline in pre-dose morning FEF25-75% at baseline and at all subsequent clinic visits are presented by treatment in the ITT population. Please note: adjusted mean is reported with its 95%IC. | Pre-dose morning at week 4 (V3), week 12 (V4), week 18 (V5) and week 24 (V6) |
| Change From Baseline in Pre-dose Morning Inspiratory Capacity (IC) at All Clinic Visits | IC is the maximum volume of air that can be inspired following a normal, quiet expiration and is equal to tidal volume + inspiratory reserve volume. In airflow obstruction, hyperinflation of the lung and chest wall during tidal breathing (and during exercise) increases the work of breathing and contributes to the sensation of dyspnoea. The lower the volume, the worse the outcome and, consequently, the impairment. Please note that adjusted mean is reported with its 95%IC. | Pre-dose morning at week 4 (V3), week 12 (V4), week 18 (V5) and week 24 (V6) |
| Change From Baseline in the Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 12 and Week 24 | The SGRQ measures health impairment in patients with COPD. It is in two parts: Part I produces the Symptoms score, Part 2 the Activity and Impacts scores. Scaling of items
Lower the scores, better the health. Each item is "weighted" empirically. Scores range from 0 to 100, higher scores mean poor health. Part 1(Q 1-8) covers the patients' recollection of their symptoms over a preceding period that may range 1 month to 1 year. Part 2 (Q 9-16) addresses patients' current state. Activity score just measures disturbances to patients daily physical activity. Impacts score covers a wide range of disturbances of psycho-social function. Please note: adjusted mean is reported with its 95%IC. | At weeks 12 and 24 |
| Change From Baseline in the Number of Patients With SGRQ Total Score ≤ -4 (Defined as "Responders") at Week 24 | The percentage of patients classified as SGRQ total score responders (i.e. change from baseline in total score ≤ -4) at Week 24 was reported. SGRQ response = Change from baseline in total score ≤ -4; SGRQ non-response = Change from baseline in total score > -4 or missing data. | At week 24 |
| Changes From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) at All Clinical Visits | The COPD assessment test (CAT) is a self-administered questionnaire assessing globally the impact of COPD (cough, sputum, dysnea, chest tighteness) on health status. It's a simple, eight-item/question, health status instrument for patients with COPD to define the level of its impact on daily life. Each item can score from 0 (best outcome) to 5 (worst outcome). Hence, CAT total score, which is the sum of the single items' scores, ranges from 0 to 40. Higher scores denote a more severe impact of COPD on a patient's life. No target score represents the best achievable outcome. Please note that adjusted mean is reported with its 95%IC. | At week 4 (V3), week 12 (V4), week 18 (V5) and week 24 (V6) |
| Change From Baseline to Each Inter-Visit Period and to the Entire Randomised Treatment Period in the Percentage of Days Without Intake of Rescue Medication | The percentage (%) of days without intake of rescue medications was evaluated on the basis of the infos recorded daily by each patient. The % of days in the run-in period was calculated as follows: % of days without rescue medication = (Number of days without rescue medication during the run-in period / Number of days with consistent data recorded during this period)*100. The % of days in each inter-visit period during the randomised treatment period was calculated as follows: • % of days without rescue medication = (Number of days without rescue medication during the inter-visit period / Number of days with consistent data recorded during this period)*100. The % of days in the entire randomised treatment period was calculated as follows: • % of days without rescue medication = (Number of days without rescue medication during the randomised treatment period / Number of days with consistent data recorded during this period)*100. | Weeks 1-4 (V2-V3); Weeks 5-12 (V3-V4); Weeks 13-18 (V4-V5); Weeks 19-24 (V5-V6); Weeks 1-24 (randomised treatment period) |
| Change From Baseline to Each Inter-Visit Period and to the Entire Treatment Period in the Average Use of Rescue Medication (Number of Puffs/Day) | The average use of rescue medication is expressed in "puffs/day". Data on each interval indicated in the timeframe and over the 24-week of the randomised treatment period is presented. | Weeks 1-4 (V2-V3); Weeks 5-12 (V3-V4); Weeks 13-18 (V4-V5); Weeks 19-24 (V5-V6); Weeks 1-24 (randomised treatment period) |
| EQ-5D-3L Index at All Clinic Visits | The EQ-5D-3L (euro quality of life) consists of the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprises 5 dimensions:
| At week 0 (V2), week 12 (V4) and week 24 (V6) |
| EQ-5D-3L VAS Scores at All Clinic Visits | The EQ-5D-3L (euro quality of life) consists of the EQ-5D descriptive system and the EQ VAS. The EQ VAS records the patient's self-rated health on a vertical, visual analogue scale where the endpoints are 'Worst imaginable health state' (0) and 'Best imaginable health state' (100). | At week 0 (V2), week 12 (V4) and week 24 (V6) |
| Total Number of Hospital Admissions Due to COPD and to Other Causes | This health-economic outcome is expressed by the number of Hospital Admissions due to COPD and to Other Causes overall. | From baseline to week 24 (V6) |
| Total Number of Oxygen Therapy Use Due to COPD | This health-economic outcome is expressed by the number of oxygen therapy use due to COPD. | From baseline to week 24 (V6) |
| Total Number of Unplanned Diagnostic or Instrumental Tests Performed Due to COPD | This health-economic outcome is expressed by the number of Diagnostic or Instrumental tests performed due to COPD. | From baseline to week 24 (V6) |
| Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | AE=An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. Serious AE= An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. ADR=A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility Serious ADR=An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. Severe AE= "Severe" refers to the intensity of an AE; the event itself may be of relatively minor medical significance but intense. | From baseline to week 24 (V6) |
| Beijing |
| Beijing Municipality |
| 100020 |
| China |
| Chiesi clinical Trial Site 156017 | Beijing | Beijing Municipality | 100029 | China |
| Chiesi Clinical Trial Site 156012 | Beijing | Beijing Municipality | 100144 | China |
| Chiesi Clinical Trial Site 156045 | Chongqing | Chongqing Municipality | 400000 | China |
| Chiesi Clinical Trial Site 156002 | Fuzhou | Fujian | 350005 | China |
| Chiesi clinical Trial Site 156024 | Foshan | Guangdong | 528000 | China |
| Chiesi Clinical Trial Site 156048 | Guangzhou | Guangdong | 510000 | China |
| Chiesi Clinical Trial Site 156013 | Guangzhou | Guangdong | 510080 | China |
| Chiesi Clinical Trial Site 156008 | Zhanjiang | Guangdong | 524000 | China |
| Chiesi Clinical Trial site 156003 | Nanning | Guangxi | 530021 | China |
| Chiesi clinical Trial Site 156020 | Haikou | Hainan | 570100 | China |
| Chiesi Clinical Trial Site 156044 | Shijiangzhuang | Hebei | 050000 | China |
| Chiesi Clinical Trial Site 156040 | Changsha | Hunan | 410000 | China |
| Chiesi Clinical Trial Site 156043 | Baotou | Inner Mongolia | 014000 | China |
| Chiesi Clinical Trial Site 156015 | Baotou | Inner Mongolia | 014010 | China |
| Chiesi Clinical Trial Site 156004 | Huai'an | Jiangsu | 223300 | China |
| Chiesi clinical Trial Site 156033 | Jiangyin | Jiangsu | 320281 | China |
| Chiesi clinical Trial Site 156022 | Nanjing | Jiangsu | 210006 | China |
| Chiesi Clinical Trial Site 156047 | Jiujiang | Jiangxi | 332000 | China |
| Chiesi Clinical Trial Site 156041 | Nanchang | Jiangxi | 330000 | China |
| Chiesi clinical Trial Site 156028 | Nanchang | Jiangxi | 330006 | China |
| Chiesi Clinical Trial Site 156042 | Pingxiang | Jiangxi | 337000 | China |
| Chiesi clinical Trial Site 156023 | Changchun | Jilin | 130000 | China |
| Chiesi Clinical Trial Site 156036 | Changchun | Jilin | 130000 | China |
| Chiesi clinical Trial Site 156019 | Changchun | Jilin | 130021 | China |
| Chiesi Clinical Trial Site 156007 | Shenyang | Liaoning | 110004 | China |
| Chiesi clinical Trial Site 156025 | Yinchuan | Ningxia | 750000 | China |
| Chiesi Clinical Trial Site 156014 | Shanghai | Shanghai Municipality | 200025 | China |
| Chiesi clinical Trial Site 156037 | Shanghai | Shanghai Municipality | 200031 | China |
| Chiesi Clinical Trial Site 156005 | Shanghai | Shanghai Municipality | 200072 | China |
| Chiesi Clinical Trial Site 156006 | Shanghai | Shanghai Municipality | 200433 | China |
| Chiesi Clinical Trial Site 156011 | Shanghai | Shanghai Municipality | 200433 | China |
| Chiesi Clinical Trial Site 156038 | Shanghai | Shanghai Municipality | 210009 | China |
| Chiesi Clinical Trial Site 156039 | Taiyuan | Shanxi | 030001 | China |
| Chiesi clinical Trial Site 156035 | Chengdu | Sichuan | 610000 | China |
| Chiesi Clinical Trial Site 156010 | Chengdu | Sichuan | 610041 | China |
| Chiesi clinical Trial Site 156032 | Chongqing | Sichuan | 400000 | China |
| Chiesi clinical Trial Site 156034 | Tianjin | Tianjin Municipality | 300052 | China |
| Chiesi clinical Trial Site 156018 | Hangzhou | Zhejiang | 310014 | China |
| Chiesi Clinical Trial Site 156046 | Linhai | Zhejiang | 317000 | China |
| Chiesi Clinical Trial Site 156001 | Guangzhou | 510230 | China |
| Chiesi Clinical Trial Site 410003 | Chuncheon | Gang'weondo | 24289 | South Korea |
| Chiesi Clinical Trial Site 410012 | Bucheon-si | Gyeonggido | 14584 | South Korea |
| Chiesi Clinical Trial Site 410001 | Bucheon-si | Gyeonggido | 420-717 | South Korea |
| Chiesi Clinical Trial Site 410002 | Goyang-si | Gyeonggido | 10380 | South Korea |
| Chiesi Clinical Trial Site 410005 | Jeonju | Jeonrabugdo | 54907 | South Korea |
| Chiesi Clinical Trial Site 410008 | Seoul | Seoul Teugbyeolsi | 07345 | South Korea |
| Chiesi Clinical Trial Site 410007 | Seoul | Seoul Teugbyeolsi | 07985 | South Korea |
| Chiesi Clinical Trial Site 410004 | Seoul | Seoul Teugbyeolsi | 100-032 | South Korea |
| Chiesi Clinical Trial Site 410006 | Seoul | Seoul Teugbyeolsi | 136-705 | South Korea |
| Chiesi Clinical Trial Site 410009 | Gyeonggi-do | Seoul Teugbyeols | 135-720 | South Korea |
| Chiesi Clinical Trial Site 410010 | Daegu | Ulsan | 705-703 | South Korea |
| Chiesi Clinical Trial Site 410011 | Seoul | 04401 | South Korea |
| Chiesi Clinical Trial Site 410013 | Seoul | 2559 | South Korea |
| Chiesi Clinical Trial Site 410014 | Seoul | 5030 | South Korea |
| Chiesi Clinical Trial Site 158001 | Keelung | Keelung Municipality | 204 | Taiwan |
| Chiesi Clinical Trial Site 158004 | Kaohsiung City | Penghu | 83301 | Taiwan |
| Chiesi Clinical Trial Site 158003 | Douliu | Yunlin | 64041 | Taiwan |
| Chiesi Clinical Trial Site 158010 | Changhua | 500 | Taiwan |
| Chiesi Clinical Trial Site 158006 | Kaohsiung City | 824 | Taiwan |
| Chiesi Clinical Trial Site 158008 | Taichung | Taiwan |
| Chiesi Clinical Trial Site 158005 | Taipei | 11217 | Taiwan |
| Chiesi Clinical Trial Site 158011 | Taipei | 220 | Taiwan |
| FG001 | Symbicort Turbuhaler 160/4.5 µg | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
| ITT Population |
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| NOT COMPLETED |
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Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis.
Not provided
| ID | Title | Description |
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| BG000 | CHF 5993 100/6/12.5 µg - ITT Population | Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg (BDP/FF/GB), 2 inhalations bid, for a total daily dose of 400/24/50 μg BDP/FF/GB respectively, administered via pMDI. If patients were used to inhaling their pMDI COPD medications with a spacer device, the AeroChamber PlusTM was used with the study pMDI treatments, dispensed to the patients at V2 (Week 0) and V4 (Week 12). CHF 5993 100/6/12.5 µg: Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose |
| BG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
| BG002 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Pre-dose Forced Expiratory Volume Within the First Second (FEV1) at Week 24 | FEV1 measures the amount, or volume, exhaled by a patient in the first second of the expiration after a full inspiration. The lower the values, more severe the airflow limitation. For FEV1, the highest value from 3 technically acceptable attempts was recorded irrespective of the curve they were derived from. The chosen highest value had not to exceed the second highest by more than 150 mL; if the difference was larger, up to 8 measurements were performed and the largest value reported. Please note that the adjusted mean is reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | Liters | Week 24 (Visit 6) |
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| Primary | Change From Baseline in 2-hour Post-dose FEV1 at Week 24 | FEV1 measures the amount, or volume, exhaled by a patient in the first second of the expiration after a full inspiration. The lower the values, more severe the airflow limitation. For FEV1, the highest value from 3 technically acceptable attempts was recorded irrespective of the curve they were derived from. The chosen highest value had not to exceed the second highest by more than 150 mL; if the difference was larger, up to 8 measurements were performed and the largest value reported. Please note that the adjusted mean is reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | Liters | Week 24 (Visit 6) |
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| Secondary | Change From Baseline in Pre-dose Morning FEV1 at All the Other Clinic Visits | FEV1 measures the amount, or volume, exhaled by a patient in the first second of the expiration after a full inspiration. The lower the values, more severe the airflow limitation. For FEV1, the highest value from 3 technically acceptable attempts was recorded irrespective of the curve they were derived from. The chosen highest value had not to exceed the second highest by more than 150 mL; if the difference was larger, up to 8 measurements were performed and the largest value reported. Please note that the adjusted mean is reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | Liters | Pre-dose morning at week 4 (visit 3), week 12 (visit 4), week 18 (visit 5), week 24 (visit 6) |
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| Secondary | Change From Baseline at 2-hour Post-dose FEV1 at All the Clinic Visits | FEV1 measures the amount, or volume, exhaled by a patient in the first second of the expiration after a full inspiration. The lower the values, more severe the airflow limitation. For FEV1, the highest value from 3 technically acceptable attempts was recorded irrespective of the curve they were derived from. The chosen highest value had not to exceed the second highest by more than 150 mL; if the difference was larger, up to 8 measurements were performed and the largest value reported. Please note that the adjusted mean is reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | liters | 2-hour post-dose morning at week 0 (V2), week 4 (V3), week 12 (V4), week 18 (V5), week 24 (V6) |
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| Secondary | Change From Baseline in Pre-dose FEV1 ≥ 100 mL at Week 24 | FEV1 response is defined as a change from baseline in pre-dose morning FEV1 ≥ 100 mL. If the change from baseline is < 100 mL the patient is classified as a non-responder in terms of FEV1. Patients with missing pre-dose morning FEV1 value at the relevant time points were also be classified as non-responders. The number and percentage of FEV1 responders/non-responders (distinguishing also the two categories of non-responders: with a change from baseline actually < 100 mL or with missing data) at Visit 6 are presented by treatment group. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Count of Participants | Participants | Week 24 (V6) |
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| Secondary | Changes From Pre-Dose to the 2-Hour Post-Dose Value of FEV1 at Each Visit From Visit 3 Onwards | The changes from pre-dose to the 2-hour post-dose morning FEV1 at each clinic visit from V3 onwards are presented by treatment in the ITT population. Please note that the adjusted mean is reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | Liters | Week 4 (V3), week 12 (V4), week 18 (V5), week 24 (V6) |
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| Secondary | Adjusted Rate Per Patient Per Year of Moderate or Severe COPD Exacerbations Over 24 Weeks of Treatment | Moderate or Severe COPD exacerbations during the randomised treatment period derived from the COPD exacerbations (E) eCRF form were considered for the analysis. Only E with start date ≥ date of start of randomised treatment period and ≤ date of end of randomised treatment period were considered. Please note that in the analysis, two COPD E were considered as a single episode if the 2nd E started less than 10 days:
| Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Number | 95% Confidence Interval | events per patient per year | Over the 24-week treatment period |
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| Secondary | Time to First Moderate or Severe COPD Exacerbation Over 24 Weeks of Treatment | In patients with at least one moderate/severe COPD exacerbation, time to first moderate/severe COPD exacerbation was calculated as the time in weeks between the start date of randomised treatment period and the date at which the first COPD exacerbation occurs. Time to first moderate/severe COPD exacerbation (weeks) = (date of start of first moderate/severe COPD exacerbation - date of start of randomised treatment period)/7. Please note that the Rows don't represent mutually exclusive and exhaustive categories of the overall number of participants analyzed (N=351 for CHF 5993 and N=355 for Symbicort Turbuhaler). The number of exacerbation-free patients at the beginning of each study period is reported for each row (not the number of participants analyzed), with the relative cumulative number of patients with first moderate/severe exacerbation at the end of each study period (unit of measure). | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Number | # of pts with event at end of period | From baseline to week 24 (EOT) |
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| Secondary | Change From Baseline in Pre-Dose Morning Forced Vital Capacity (FVC) at All Clinic Visits | FVC is defined as the total amount of air exhaled during the FEV test. Forced vital capacity, together with Forced Expiratory Volume, are lung function tests that are measured during spirometry. The lower the capacity, the worse the respiratory functionality. Change from Baseline in Pre-Dose Morning Forced Vital Capacity (FVC) at all clinic visits are presented by treatment in the ITT population. Please note that adjusted mean was reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | Liters | Pre-dose morning, week 4 (V3), week 12 (V4), week 18 (V5), week 24 (V6) |
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| Secondary | Change From Baseline in 2-Hour Post-Dose Morning FVC at All Clinic Visits | FVC is defined as the total amount of air exhaled during the FEV test. Forced vital capacity, together with Forced Expiratory Volume, are lung function tests that are measured during spirometry. The lower the capacity, the worse the respiratory functionality. Change from Baseline in 2-hour post-dose Forced Vital Capacity (FVC) at all clinic visits are presented by treatment in the ITT population. Please note that adjusted mean is reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | liters | 2-hour post dose, week 4 (V3), week 12 (V4), week 18 (V5), week 24 (V6) |
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| Secondary | Change From Pre-Dose to the 2-Hour Post-Dose Value of FVC at Each Visit From Visit 3 Onwards | FVC is defined as the total amount of air exhaled during the FEV test. Forced vital capacity, together with Forced Expiratory Volume, are lung function tests that are measured during spirometry. The lower the capacity, the worse the respiratory functionality. Change from Pre-Dose to the 2-Hour Post-Dose Value of Forced Vital Capacity (FVC) at all clinic visits from V3 onwards are presented by treatment in the ITT population. Please note that adjusted mean is reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | Liters | From Pre-Dose to the 2-Hour Post-Dose at week 4 (V3), week 12 (V4), week 18 (V5) and week 24 (V6) |
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| Secondary | Pre-Dose FEV1/FVC at All Clinic Visits | The FEV1/FVC ratio, also called modified Tiffeneau-Pinelli index, is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease. The FEV1/FVC ratio is used to determine if the pattern is obstructive, restrictive, or normal. Chronic airflow limitation can be generally defined as fixed ratio of forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) < 0.70 after bronchodilation. So the lower the value, the worse the outcome and the pattern. Pre-dose FEV1/FVC at each visit was summarised by treatment group using descriptive statistics. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | Standard Deviation | ratio | Pre-dose at baseline (V1), week 0 (V2), week 4 (V3), week 12 (V4), week 18 (V5), week 24 (V6) |
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| Secondary | Change From Baseline in Pre-dose Morning Forced Expiratory Flow Measured Between 25% and 75% of a Forced Vital Capacity (FEF25-75%) at All Clinic Visits | FEF25-75% is defined as "forced expiratory flow over the middle one-half of the FVC; the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled." A reduced FEF25-75% is thought to be a marker of small airway obstruction. Hence, the lower the parameter, the worse the status of airways. Among the various measurements collected during conventional spirometry, forced expiratory flow at 25% and 75% of the pulmonary volume (FEF25-75) measures the average flow rates of medium-to-small airways during the forced vital capacity (FVC) segment to testing and presents the status of those airways in patients. The changes from baseline in pre-dose morning FEF25-75% at baseline and at all subsequent clinic visits are presented by treatment in the ITT population. Please note: adjusted mean is reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | Liters | Pre-dose morning at week 4 (V3), week 12 (V4), week 18 (V5) and week 24 (V6) |
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| Secondary | Change From Baseline in Pre-dose Morning Inspiratory Capacity (IC) at All Clinic Visits | IC is the maximum volume of air that can be inspired following a normal, quiet expiration and is equal to tidal volume + inspiratory reserve volume. In airflow obstruction, hyperinflation of the lung and chest wall during tidal breathing (and during exercise) increases the work of breathing and contributes to the sensation of dyspnoea. The lower the volume, the worse the outcome and, consequently, the impairment. Please note that adjusted mean is reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | Liters | Pre-dose morning at week 4 (V3), week 12 (V4), week 18 (V5) and week 24 (V6) |
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| Secondary | Change From Baseline in the Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 12 and Week 24 | The SGRQ measures health impairment in patients with COPD. It is in two parts: Part I produces the Symptoms score, Part 2 the Activity and Impacts scores. Scaling of items
Lower the scores, better the health. Each item is "weighted" empirically. Scores range from 0 to 100, higher scores mean poor health. Part 1(Q 1-8) covers the patients' recollection of their symptoms over a preceding period that may range 1 month to 1 year. Part 2 (Q 9-16) addresses patients' current state. Activity score just measures disturbances to patients daily physical activity. Impacts score covers a wide range of disturbances of psycho-social function. Please note: adjusted mean is reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | At weeks 12 and 24 |
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| Secondary | Change From Baseline in the Number of Patients With SGRQ Total Score ≤ -4 (Defined as "Responders") at Week 24 | The percentage of patients classified as SGRQ total score responders (i.e. change from baseline in total score ≤ -4) at Week 24 was reported. SGRQ response = Change from baseline in total score ≤ -4; SGRQ non-response = Change from baseline in total score > -4 or missing data. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Count of Participants | Participants | At week 24 |
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| Secondary | Changes From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) at All Clinical Visits | The COPD assessment test (CAT) is a self-administered questionnaire assessing globally the impact of COPD (cough, sputum, dysnea, chest tighteness) on health status. It's a simple, eight-item/question, health status instrument for patients with COPD to define the level of its impact on daily life. Each item can score from 0 (best outcome) to 5 (worst outcome). Hence, CAT total score, which is the sum of the single items' scores, ranges from 0 to 40. Higher scores denote a more severe impact of COPD on a patient's life. No target score represents the best achievable outcome. Please note that adjusted mean is reported with its 95%IC. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | At week 4 (V3), week 12 (V4), week 18 (V5) and week 24 (V6) |
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| Secondary | Change From Baseline to Each Inter-Visit Period and to the Entire Randomised Treatment Period in the Percentage of Days Without Intake of Rescue Medication | The percentage (%) of days without intake of rescue medications was evaluated on the basis of the infos recorded daily by each patient. The % of days in the run-in period was calculated as follows: % of days without rescue medication = (Number of days without rescue medication during the run-in period / Number of days with consistent data recorded during this period)*100. The % of days in each inter-visit period during the randomised treatment period was calculated as follows: • % of days without rescue medication = (Number of days without rescue medication during the inter-visit period / Number of days with consistent data recorded during this period)*100. The % of days in the entire randomised treatment period was calculated as follows: • % of days without rescue medication = (Number of days without rescue medication during the randomised treatment period / Number of days with consistent data recorded during this period)*100. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | Standard Deviation | percentage of days | Weeks 1-4 (V2-V3); Weeks 5-12 (V3-V4); Weeks 13-18 (V4-V5); Weeks 19-24 (V5-V6); Weeks 1-24 (randomised treatment period) |
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| Secondary | Change From Baseline to Each Inter-Visit Period and to the Entire Treatment Period in the Average Use of Rescue Medication (Number of Puffs/Day) | The average use of rescue medication is expressed in "puffs/day". Data on each interval indicated in the timeframe and over the 24-week of the randomised treatment period is presented. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | Standard Deviation | puffs/day | Weeks 1-4 (V2-V3); Weeks 5-12 (V3-V4); Weeks 13-18 (V4-V5); Weeks 19-24 (V5-V6); Weeks 1-24 (randomised treatment period) |
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| Secondary | EQ-5D-3L Index at All Clinic Visits | The EQ-5D-3L (euro quality of life) consists of the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprises 5 dimensions:
| Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | Standard Deviation | index (decimal number) | At week 0 (V2), week 12 (V4) and week 24 (V6) |
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| Secondary | EQ-5D-3L VAS Scores at All Clinic Visits | The EQ-5D-3L (euro quality of life) consists of the EQ-5D descriptive system and the EQ VAS. The EQ VAS records the patient's self-rated health on a vertical, visual analogue scale where the endpoints are 'Worst imaginable health state' (0) and 'Best imaginable health state' (100). | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Mean | Standard Deviation | score on a scale | At week 0 (V2), week 12 (V4) and week 24 (V6) |
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| Secondary | Total Number of Hospital Admissions Due to COPD and to Other Causes | This health-economic outcome is expressed by the number of Hospital Admissions due to COPD and to Other Causes overall. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Number | no of admission | From baseline to week 24 (V6) |
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| Secondary | Total Number of Oxygen Therapy Use Due to COPD | This health-economic outcome is expressed by the number of oxygen therapy use due to COPD. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Number | no of oxygen therapy | From baseline to week 24 (V6) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Unplanned Diagnostic or Instrumental Tests Performed Due to COPD | This health-economic outcome is expressed by the number of Diagnostic or Instrumental tests performed due to COPD. | Intention-to-treat (ITT) Population: All unique randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline. If a patient was unintentionally randomised twice in the study, only the data collected from the initial randomisation site were considered for analysis. | Posted | Number | no of tests | From baseline to week 24 (V6) |
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| Secondary | Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | AE=An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. Serious AE= An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. ADR=A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility Serious ADR=An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. Severe AE= "Severe" refers to the intensity of an AE; the event itself may be of relatively minor medical significance but intense. | Safety Population: all randomised patients who received at least one dose of the study treatment. | Posted | Number | number of events | From baseline to week 24 (V6) |
|
Throughout the study from screening (V1, week -2), during the whole treatment period (V2-V5) till the End of Study (V6, at week 24 or at earlier patient withdrawal)
It was the Investigator's responsibility to collect all the AEs (adverse events), both serious and non-serious, derived by spontaneous, unsolicited reports of patients, by observation and by routine open questioning from the signature of the ICF until the patient's study participation ended.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CHF 5993 100/6/12.5 µg - Safety Population | Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg (BDP/FF/GB), 2 inhalations bid, for a total daily dose of 400/24/50 μg BDP/FF/GB respectively, administered via pMDI. If patients were used to inhaling their pMDI COPD medications with a spacer device, the AeroChamber PlusTM was used with the study pMDI treatments, dispensed to the patients at V2 (Week 0) and V4 (Week 12). CHF 5993 100/6/12.5 µg: Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose | 1 | 352 | 40 | 352 | 215 | 352 |
| EG001 | Symbicort Turbuhaler 160/4.5 µg - Safety Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg | 3 | 355 | 60 | 355 | 238 | 355 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrolithiasis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| subdural hematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ostearthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Papillary cystadenoma lymphomatous | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Phaeochromocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Erythropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac valve disease | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure Chronic | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cor pulmonale chronic | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tachiycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ventricular arrythmia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ventricular dyskinesia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Inner ear disorders | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thyroid cyst | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Angle closure glaucome | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lacrimation increase | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Refraction disorder | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic gasritis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric dilatation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric mucosal lesion | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrolithiasis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gingival ulceration | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Large intestinal polyp | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukoplakia oral | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mesenteric vascular insufficiency | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mouth ulcerations | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oesophageal disorder | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic hepatitis C | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Latent syphilis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Mycobacterial infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Tinea capitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Computerised tomogram kidney | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Electrocardiogram ST segment abnormal | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphocyte percentage decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphocyte percentage increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutrophil percentage decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutrophil percentage increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fluid imbalance | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyponantraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Intervetebral disc protusion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Oesophageal papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Papillary cystadenoma lymphomatosum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Phaechromocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebral arteriosclerosis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Monoplegia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neuritis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Subdural effusion | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tic | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Prostatic calcification | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural adhesion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary bulla | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Reflux laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Macule | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Aortic arteriosclerosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
The TRIVERSYTI study was impacted in its later stage by the COVID-19 pandemic. The study conduct was adapted shortly after the breakthrough of the pandemic to ensure the safety of the patients and staff as well as the study continuity. Additionally, the monitoring activities were impacted by the partial or total lockdown at country level as a result of the global spread of COVID-19.Specific process for performing and reporting of Remote Visits was followed due to COVID spread.
Results of this study may be published or presented at scientific meetings. If a publication is presented by the Investigator, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Data from individual study sites must not be published separately.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial INFO | Chiesi Farmaceutici S.p.A. | +39 0521 2791 | clinicaltrials_info@chiesi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2019 | Feb 10, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| D000068759 | Formoterol Fumarate |
| D006024 | Glycopyrrolate |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D000644 | Quaternary Ammonium Compounds |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| China |
|
| Taiwan |
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - ITT Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|
|
|
|
|
|
|
| OG001 | Symbicort Turbuhaler 160/4.5 µg - Safety Population | Fixed combination of 160 µg budesonide (BUD) + 4.5 µg formoterol fumarate (FF), 2 inhalations a day, for a total daily dose of 640/18 μg BUD/FF respectively, administered via dry powder inhaler (DPI). 160 µg budesonide + 4.5 µg formoterol fumarate: Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg |
|
|