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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20180475 | Other Identifier | http://www.chinadrugtrials.org.cn/ |
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Primary Objective
To demonstrate that CHF 1535 pMDI is non-inferior to Symbicort® Turbohaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 at Week 24) in patients with COPD.
Secondary Objectives
This was a Phase III, multicenter, randomized, double-blind, double-dummy, active-controlled, 2-arm parallel-group study designed to evaluate the non-inferiority of CHF 1535 100/6 µg pMDI (400/24 µg/day) versus Symbicort® Turbohaler® 160/4.5 µg (640/18 µg/day) in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).
The study included the following phases:
The total study duration per participant was 30 weeks, including the 6-week run-in period, 24-week treatment phase, and follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF 1535 100/6 µg pMDI | Experimental | The experimental arm included 377 patients who received CHF 1535, a fixed-dose combination of beclometasone dipropionate (100 µg) and formoterol fumarate (6 µg). The treatment was administered as two inhalations twice daily (b.i.d.) via a pressurized metered-dose inhaler (pMDI), resulting in a total daily dose of 400 µg of beclometasone dipropionate and 24 µg of formoterol fumarate. During the initial 4-week run-in phase, patients in this group were treated with Symbicort® Turbohaler® 160/4.5 µg, administered as two inhalations b.i.d., to stabilize their clinical condition. After this period, patients transitioned to the randomized treatment phase, where they received CHF 1535 for 24 weeks. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
|
| Symbicort® Turbohaler® | Active Comparator | The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo | Drug | 2 inhalations BID Total Daily Dose = 400/24µg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pre-dose Morning First Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) measures lung function by quantifying the volume of air forcefully exhaled during the first second of a forced expiratory maneuver. Spirometry was conducted at baseline and Week 24 to assess treatment effects in patients with moderate-to-severe COPD. Baseline FEV1, recorded during the run-in phase before randomization, was used as the reference for changes post-treatment. Tests were performed under controlled conditions using calibrated equipment. Patients inhaled deeply to full capacity and exhaled forcefully into the spirometer. Each completed at least three acceptable maneuvers, with the highest value recorded for analysis. FEV1 higher values indicate better lung function. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction, making it a key parameter in COPD management. | Baseline and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pre-dose Morning FEV1 at All the Other Clinic Visits in Patients With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) is a key measure of lung function that quantifies the volume of air a patient can exhale forcefully in the first second of a forced expiratory maneuver. Spirometry was conducted at baseline and at Weeks 4, 12, 18, and 24 to evaluate treatment effects in patients with moderate-to-severe COPD. Baseline FEV1, recorded during the run-in phase before randomization, served as a reference for post-treatment changes. Tests were performed under controlled conditions with calibrated equipment. Patients were seated, instructed to inhale deeply to full capacity, and exhale forcefully into the spirometer. At least three acceptable and repeatable maneuvers were completed, and the highest value was used for analysis. FEV1 is measured in liters (L), with higher values indicating better lung function. Increases in FEV1 reflect improved airway patency and reduced obstruction, while decreases indicate worsening airflow limitation. |
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Inclusion Criteria:
Patients had to meet all of the following criteria to be eligible for enrolment into the study:
Male and female adults aged ≥40 years, of Chinese ethnicity with written informed consent prior to any study-related procedure;
Patients with a diagnosis of COPD (according to the GOLD document [1], updated 2017) 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, 10 to 15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI; Note: If this criterion was not met at screening, the test could be repeated no more than 7 days before the randomisation visit;
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 in treatment 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 Turbohaler®);
A cooperative attitude and ability to be trained to use correctly the COPD questionnaires.
Exclusion Criteria:
Patients requiring use of the following medications:
COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period;
Changes in dose, schedule, formulation or product of oral xanthine derivatives (e.g. theophylline) in the month prior to the screening visit or during the run-in period. Stop of xanthines prior to the screening visit was allowed;
Known respiratory disorders other than COPD which may have impacted the efficacy of the study treatment according to the Investigator's judgement. This could have included, but was not limited to, α-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease;
Diagnosis of asthma, history of allergic rhinitis or atopy (atopy which may have risen contra-indications or impacted the efficacy of the study according to the Investigator's judgement);
Patients treated with long-acting antihistamines (e.g. astemizole, terfenadine) unless taken at stable regimen at least 2 months prior to screening and maintained constant during the study, or if taken as required (PRN);
Patients requiring long-term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;
History of hypersensitivity to β2-agonists, corticosteroids or any of the excipients contained in any of the formulations used in the study;
Patients treated with non-cardioselective β-blockers in the 4 weeks preceding the screening visit or during the run-in period;
Patients who had a clinically significant (CS) active cardiovascular condition (such as, but not limited to, unstable ischemic 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:
An abnormal and CS 12-lead ECG that resulted in an active medical problem which may have impacted the safety of the patient or showed Fridericia-corrected QT interval (QTcF) >450 ms for males or QTcF >470 ms for females;
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, significant hepatic impairment, significant renal impairment or other which may impact the feasibility of the results of the study according to the Investigator's judgment;
CS laboratory abnormalities indicating a significant or unstable concomitant disease which may have impacted the efficacy or the safety of the study treatment according to the Investigator's judgment;
Patients with serum potassium levels <3.5 mEq/L (or 3.5 mmol/L);
History of alcohol abuse and/or substance/drug abuse within 12 months prior to the screening visit;
Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they were using one or more of the following highly effective contraceptive measures:
Participation in an interventional clinical trial with intake of the last dose of any investigational drug <12 weeks preceding baseline visit (last dose <5 half-lives prior to baseline visit for biologics).
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| Name | Affiliation | Role |
|---|---|---|
| Professor Fuqiang WEN, M.D., Ph.D. | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 15604 - Anhui Provincial Hospital | Hefei | Anhui | 230001 | China | ||
| Site 15635 - The Second Hospital of Anhui Medical Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39529298 | Result | Wen F, Wu Y, Xing C, Zhu Y, Chen Y, Mei X, Corradi M, Cappellini G, Calabro E, Amodio S, Zhu C, Galkin D. Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised Study. COPD. 2024 Dec;21(1):2425157. doi: 10.1080/15412555.2024.2425157. Epub 2024 Nov 11. |
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After enrollment, participants entered a 6-week run-in phase with open-label Symbicort® Turbohaler® (budesonide/formoterol) to standardize baseline therapy. During this phase, spirometry, adherence, and rescue medication use were monitored to ensure eligibility and compliance. Participants who failed to meet inclusion criteria or demonstrated protocol violations were excluded before randomization. This phase ensured consistency in baseline conditions prior to treatment assignment.
Recruitment occurred across 50 centers in China, where 1,182 patients were screened, and 750 were randomized to CHF 1535 (377) or Symbicort® (373). Pre-screening evaluated eligibility, followed by screening with medical history review, spirometry, and inclusion/exclusion criteria confirmation. Eligible patients entered a 6-week run-in phase with open-label Symbicort® Turbohaler® to standardize therapy before randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | CHF 1535 100/6 µg pMDI - ITT Population | 2 inhalations BID Total Daily Dose = 400/24µg CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo: The experimental arm included 377 patients who received CHF 1535, a fixed-dose combination of beclometasone dipropionate (100 µg) and formoterol fumarate (6 µg). The treatment was administered as two inhalations twice daily (b.i.d.) via a pressurized metered-dose inhaler (pMDI), resulting in a total daily dose of 400 µg of beclometasone dipropionate and 24 µg of formoterol fumarate. During the initial 4-week run-in phase, patients in this group were treated with Symbicort® Turbohaler® 160/4.5 µg, administered as two inhalations b.i.d., to stabilize their clinical condition. After this period, patients transitioned to the randomized treatment phase, where they received CHF 1535 for 24 weeks. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
| 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 | Nov 9, 2017 | Jan 21, 2026 |
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| Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo | Drug | 2 inhalations BID Total Daily Dose = 640/18µg |
|
|
| Baseline and week 4, week 12, week 18 |
| Change From Baseline in Pre-dose Morning Force Vital Capacity (FVC) at All Timepoints | Forced Vital Capacity (FVC) measures the total volume of air a patient can exhale forcefully after a full inhalation, offering key insights into lung function. Baseline FVC, recorded during the run-in phase before randomization, served as a reference for evaluating changes during treatment. Spirometry tests were conducted in controlled settings with calibrated, high-precision equipment to ensure accuracy and reliability. Patients performed the test while seated, inhaling deeply to full lung capacity and exhaling forcefully and completely into the spirometer. At least three acceptable maneuvers meeting predefined criteria for consistency were required, with the highest FVC value recorded for analysis. The procedure adhered to standardized protocols, including calibration of equipment before each test, coaching by trained technicians, and monitoring for quality control. FVC is measured in liters (L); higher values indicate improved lung capacity and reduced airway obstruction. | Baseline and week 4, week 12, week 18 and week 24 |
| Change From Baseline in Pre-dose Morning Inspiratory Capacity (IC) at All Timepoints | Inspiratory Capacity (IC) measures the maximum volume of air a patient can inhale after a normal exhalation, providing key insights into lung expansion and respiratory mechanics. Baseline IC, recorded during the run-in phase before randomization, was used as a reference for treatment-related changes. Spirometry tests were performed in controlled conditions using calibrated, high-precision equipment to ensure accuracy. Patients exhaled to their functional residual capacity, then inhaled deeply into the spirometer. At least three acceptable maneuvers were completed, and the highest IC value was recorded. The procedure followed standardized protocols, including pre-test calibration, technician coaching, and quality control monitoring. IC is measured in liters (L), with higher values indicating improved lung capacity, reduced restriction, and enhanced respiratory function. | Baseline and week 4, week 12, week 18 and week 24 |
| Change From Baseline in Pre-dose Maximal Mid-expiratory Flow (MMEF) at All Timepoints | Maximal Mid-Expiratory Flow (MMEF) measured the mean expiratory flow during the middle 50% of a forced vital capacity (FVC) maneuver, reflecting airflow through small airways. It was an important indicator of small airway function, often impaired in diseases like COPD. MMEF was measured using spirometry under standardized conditions with calibrated equipment. Patients inhaled deeply to full lung capacity and exhaled forcefully into the spirometer. The highest value from at least three acceptable maneuvers was recorded. MMEF was expressed in liters per second (L/sec), with lower values indicating increased resistance in small airways, a hallmark of COPD and asthma. The parameter was particularly sensitive to detecting early changes in small airway function that may not yet be apparent in larger airway measurements like FEV1 or FVC. This sensitivity made MMEF valuable for assessing treatment efficacy and progression in diseases affecting small airway mechanics. | Baseline and week 4, week 12, week 18 and week 24 |
| Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score and Domain Scores at Week 12 and Week 24 | The SGRQ is a validated tool used to assess health-related quality of life in patients with chronic respiratory diseases. It consists of 76 items across 3 domains:
Each domain score = sum of the weights of the positive items of that domain / sum of the weights of all items of that domain)*100. Total score (0 - 100) is calculated by combining the weighted scores from each domain, with higher scores indicating a greater burden of disease and poorer quality of life. A reduction of 4 points or more in the total score is considered clinically significant. | Baseline, week 12, week 24 |
| Change From Baseline in COPD Assessment Test (CAT) | The COPD Assessment Test (CAT) is a validated eight-item questionnaire designed to assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on a patient's health status. It evaluates symptoms and quality of life, including cough, phlegm production, chest tightness, breathlessness during physical activity, sleep quality, and energy levels. Each item is scored from 0 (no impact) to 5 (severe impact), resulting in a total score range of 0 to 40, where higher scores indicate a greater disease burden and worse health status. The CAT was completed at baseline and during scheduled clinic visits throughout the treatment period. Scores were calculated by summing the responses to all eight items. A reduction in the CAT score reflects improvement in the patient's condition, with a change of 2 points or more considered clinically significant. This outcome captures changes in the patient's quality of life and provides a direct measure of the perceived impact of COPD on daily living. | At week 4, week 12, week 18 and week 24 |
| Rate of Moderate and Severe COPD Exacerbations Over 24 Weeks of Treatment. - Moderate Exacerbations Require Treatment With Systemic Corticosteroids and/or Antibiotics - Severe Exacerbations Require Hospitalisation or Result in Death | This outcome measures the frequency of moderate and severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during the treatment period. A moderate exacerbation is defined as a worsening of respiratory symptoms requiring treatment with systemic corticosteroids, antibiotics, or both, without hospitalization. A severe exacerbation is defined as a worsening of symptoms requiring hospitalization or resulting in death. Exacerbations were recorded from the start of treatment to the final scheduled visit, using data from patient-reported symptom diaries, healthcare provider assessments, and verified medical records. | Over 24 weeks of treatment |
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". A SAE is defined as any untoward medical occurrence or effect that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Over 29 weeks (from Visit 0 to Visit 6) |
| Hefei |
| Anhui |
| 231200 |
| China |
| Site 15613 - Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| Site 15611 - Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
| Site 15640 - Peking University Shougang Hospital | Beijing | Beijing Municipality | 100144 | China |
| Site 15626 - Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Site 15612 - Beijing Tong Ren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
| Site 15634 - Chongqing General Hospital | Chongqing | Chongqing Municipality | 400013 | China |
| Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District | Chongqing | Chongqing Municipality | 400020 | China |
| Site 15636 - Fujian Province Hospital | Fuzhou | Fujian | 350001 | China |
| Site 15650 - The First Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China |
| Site 15630 - Dongguan People's Hospital | Dongguan | Guangdong | 523059 | China |
| Site 15607 - The First People's Hospital of Shunde | Foshan | Guangdong | 528300 | China |
| Site 15619 - The Third Affiliated Hospital of Southern Medical University | Guangzhou | Guangdong | 510000 | China |
| Site 15608 - The First Affiliated Hospital Sun Yat-sen University | Guangzhou | Guangdong | 510030 | China |
| Site 15646 - The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510260 | China |
| Site 15651 - The Second Xiangya Hospital of Central South University | Guangzhou | Guangdong | 510260 | China |
| Site 15614 - Guangzhou Panyu central hospital | Guangzhou | Guangdong | 511400 | China |
| Site 15618 - Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | 524000 | China |
| Site 15656 - The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi Zhuang | 530021 | China |
| Site 15637 - Affiliated Hospital of Zunyi Medical College | Zunyi | Guizhou | 563099 | China |
| Site 15623 - Haikou People's Hospital | Haikou | Hainan | 570208 | China |
| Site 15645 - Hainan General Hospital | Haikou | Hainan | 570311 | China |
| Site 15654 - Henan Provincial People's Hospital | Zhengzhou | Henan | 450003 | China |
| Site 15617 - Henan Provincial Chest Hospital | Zhengzhou | Henan | 450008 | China |
| Site 15622 - The Third Hospital of Changsha | Changsha | Hu'nan | 410015 | China |
| Site 15647 - The Second hospital. University of South China | Hengyang | Hu'nan | 421001 | China |
| Site 15653 - Xiangtan Central Hospital | Xiangtan | Hu'nan | 411100 | China |
| Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | 010050 | China |
| Site 15657 - Zhong Da Hospital, Southeast University | Nanjing | Jiangsu | 210009 | China |
| Site 15627 - Nanjing Medical University Affiliated 2nd Hospital | Nanjing | Jiangsu | 210011 | China |
| Site 15621 - Wuxi People's Hospital | Wuxi | Jiangsu | 241023 | China |
| Site 15632 - Xuzhou Central Hospital | Xuzhou | Jiangsu | 221009 | China |
| Site 15659 - Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
| Site 15658 - Jilin Province People's Hospital | Changchun | Jilin | 130021 | China |
| Site 15643 - No.2 Hospital Affiliated to Jilin University | Changchun | Jilin | 130041 | China |
| Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University | Dalian | Liaoning | 116033 | China |
| Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University | Taiyuan | Shan'xi | 030001 | China |
| Site 15644 - Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Site 15629 - Shanghai East Hospital | Shanghai | Shanghai Municipality | 2000120 | China |
| Site 15628 - Shanghai Xuhui Center Hospital | Shanghai | Shanghai Municipality | 200031 | China |
| Site 15601 - Huadong Hospital Afflilliated to Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Site 15631 - Shanghai Yangpu District Centre Hospital | Shanghai | Shanghai Municipality | 200090 | China |
| Site 15610 - Tong Ren Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200336 | China |
| Site 15606 - Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| Site 15625 - Central Hospital of Shanghai Minhang District | Shanghai | Shanghai Municipality | 201199 | China |
| Site 15638 - Second Hospital of Shanxi Medical | Taiyuan | Shanxi | 0300001 | China |
| Site 15605 - West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Site 15609 - Tianjin First Center Hospital | Tianjin | Tianjin Municipality | 300192 | China |
| Site 15633 - Tianjin Haihe Hospital | Tianjin | Tianjin Municipality | 300350 | China |
| Site 15602 - Hangzhou First People's Hospital | Hangzhou | Zhejiang | 310006 | China |
| Site 15642 - Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang | 317000 | China |
| Site 15639 -The second Affiliated Hospital of Wenzhou Medical College | Wenzhou | Zhejiang | 325027 | China |
| FG001 | Symbicort® Turbohaler® - ITT Population | 2 inhalations BID Total Daily Dose = 640/18µg Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo: The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
| Safety Population (SAF) |
|
| Intention-to-treat Population (ITT) |
|
| Per Protocol Population (PP) |
|
| COMPLETED |
|
| NOT COMPLETED |
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Intention-to-Treat (ITT) population all randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | CHF 1535 100/6 µg pMDI - ITT Population | 2 inhalations BID Total Daily Dose = 400/24µg CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo: The experimental arm included 377 patients who received CHF 1535, a fixed-dose combination of beclometasone dipropionate (100 µg) and formoterol fumarate (6 µg). The treatment was administered as two inhalations twice daily (b.i.d.) via a pressurized metered-dose inhaler (pMDI), resulting in a total daily dose of 400 µg of beclometasone dipropionate and 24 µg of formoterol fumarate. During the initial 4-week run-in phase, patients in this group were treated with Symbicort® Turbohaler® 160/4.5 µg, administered as two inhalations b.i.d., to stabilize their clinical condition. After this period, patients transitioned to the randomized treatment phase, where they received CHF 1535 for 24 weeks. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
| BG001 | Symbicort® Turbohaler® - ITT Population | 2 inhalations BID Total Daily Dose = 640/18µg Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo: The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Pre-dose Morning First Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) measures lung function by quantifying the volume of air forcefully exhaled during the first second of a forced expiratory maneuver. Spirometry was conducted at baseline and Week 24 to assess treatment effects in patients with moderate-to-severe COPD. Baseline FEV1, recorded during the run-in phase before randomization, was used as the reference for changes post-treatment. Tests were performed under controlled conditions using calibrated equipment. Patients inhaled deeply to full capacity and exhaled forcefully into the spirometer. Each completed at least three acceptable maneuvers, with the highest value recorded for analysis. FEV1 higher values indicate better lung function. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction, making it a key parameter in COPD management. | The Intention-to-Treat (ITT) population included all randomized patients who received at least one dose of study treatment and had at least one post-baseline efficacy assessment. | Posted | Mean | 95% Confidence Interval | liters | Baseline and week 24 |
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| Secondary | Change From Baseline in Pre-dose Morning FEV1 at All the Other Clinic Visits in Patients With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) is a key measure of lung function that quantifies the volume of air a patient can exhale forcefully in the first second of a forced expiratory maneuver. Spirometry was conducted at baseline and at Weeks 4, 12, 18, and 24 to evaluate treatment effects in patients with moderate-to-severe COPD. Baseline FEV1, recorded during the run-in phase before randomization, served as a reference for post-treatment changes. Tests were performed under controlled conditions with calibrated equipment. Patients were seated, instructed to inhale deeply to full capacity, and exhale forcefully into the spirometer. At least three acceptable and repeatable maneuvers were completed, and the highest value was used for analysis. FEV1 is measured in liters (L), with higher values indicating better lung function. Increases in FEV1 reflect improved airway patency and reduced obstruction, while decreases indicate worsening airflow limitation. | The Intention-to-Treat (ITT) population included all randomized patients who received at least one dose of study treatment and had at least one post-baseline efficacy assessment. | Posted | Mean | 95% Confidence Interval | liters | Baseline and week 4, week 12, week 18 |
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| Secondary | Change From Baseline in Pre-dose Morning Force Vital Capacity (FVC) at All Timepoints | Forced Vital Capacity (FVC) measures the total volume of air a patient can exhale forcefully after a full inhalation, offering key insights into lung function. Baseline FVC, recorded during the run-in phase before randomization, served as a reference for evaluating changes during treatment. Spirometry tests were conducted in controlled settings with calibrated, high-precision equipment to ensure accuracy and reliability. Patients performed the test while seated, inhaling deeply to full lung capacity and exhaling forcefully and completely into the spirometer. At least three acceptable maneuvers meeting predefined criteria for consistency were required, with the highest FVC value recorded for analysis. The procedure adhered to standardized protocols, including calibration of equipment before each test, coaching by trained technicians, and monitoring for quality control. FVC is measured in liters (L); higher values indicate improved lung capacity and reduced airway obstruction. | The Intention-to-Treat (ITT) population included all randomized patients who received at least one dose of study treatment and had at least one post-baseline efficacy assessment. | Posted | Mean | 95% Confidence Interval | liters | Baseline and week 4, week 12, week 18 and week 24 |
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| Secondary | Change From Baseline in Pre-dose Morning Inspiratory Capacity (IC) at All Timepoints | Inspiratory Capacity (IC) measures the maximum volume of air a patient can inhale after a normal exhalation, providing key insights into lung expansion and respiratory mechanics. Baseline IC, recorded during the run-in phase before randomization, was used as a reference for treatment-related changes. Spirometry tests were performed in controlled conditions using calibrated, high-precision equipment to ensure accuracy. Patients exhaled to their functional residual capacity, then inhaled deeply into the spirometer. At least three acceptable maneuvers were completed, and the highest IC value was recorded. The procedure followed standardized protocols, including pre-test calibration, technician coaching, and quality control monitoring. IC is measured in liters (L), with higher values indicating improved lung capacity, reduced restriction, and enhanced respiratory function. | The Intention-to-Treat (ITT) population included all randomized patients who received at least one dose of study treatment and had at least one post-baseline efficacy assessment. | Posted | Mean | 95% Confidence Interval | liters | Baseline and week 4, week 12, week 18 and week 24 |
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| Secondary | Change From Baseline in Pre-dose Maximal Mid-expiratory Flow (MMEF) at All Timepoints | Maximal Mid-Expiratory Flow (MMEF) measured the mean expiratory flow during the middle 50% of a forced vital capacity (FVC) maneuver, reflecting airflow through small airways. It was an important indicator of small airway function, often impaired in diseases like COPD. MMEF was measured using spirometry under standardized conditions with calibrated equipment. Patients inhaled deeply to full lung capacity and exhaled forcefully into the spirometer. The highest value from at least three acceptable maneuvers was recorded. MMEF was expressed in liters per second (L/sec), with lower values indicating increased resistance in small airways, a hallmark of COPD and asthma. The parameter was particularly sensitive to detecting early changes in small airway function that may not yet be apparent in larger airway measurements like FEV1 or FVC. This sensitivity made MMEF valuable for assessing treatment efficacy and progression in diseases affecting small airway mechanics. | The Intention-to-Treat (ITT) population included all randomized patients who received at least one dose of study treatment and had at least one post-baseline efficacy assessment. | Posted | Mean | 95% Confidence Interval | L/sec | Baseline and week 4, week 12, week 18 and week 24 |
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| Secondary | Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score and Domain Scores at Week 12 and Week 24 | The SGRQ is a validated tool used to assess health-related quality of life in patients with chronic respiratory diseases. It consists of 76 items across 3 domains:
Each domain score = sum of the weights of the positive items of that domain / sum of the weights of all items of that domain)*100. Total score (0 - 100) is calculated by combining the weighted scores from each domain, with higher scores indicating a greater burden of disease and poorer quality of life. A reduction of 4 points or more in the total score is considered clinically significant. | The Intention-to-Treat (ITT) population included all randomized patients who received at least one dose of study treatment and had at least one post-baseline efficacy assessment. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, week 12, week 24 |
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| Secondary | Change From Baseline in COPD Assessment Test (CAT) | The COPD Assessment Test (CAT) is a validated eight-item questionnaire designed to assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on a patient's health status. It evaluates symptoms and quality of life, including cough, phlegm production, chest tightness, breathlessness during physical activity, sleep quality, and energy levels. Each item is scored from 0 (no impact) to 5 (severe impact), resulting in a total score range of 0 to 40, where higher scores indicate a greater disease burden and worse health status. The CAT was completed at baseline and during scheduled clinic visits throughout the treatment period. Scores were calculated by summing the responses to all eight items. A reduction in the CAT score reflects improvement in the patient's condition, with a change of 2 points or more considered clinically significant. This outcome captures changes in the patient's quality of life and provides a direct measure of the perceived impact of COPD on daily living. | The Intention-to-Treat (ITT) population included all randomized patients who received at least one dose of study treatment and had at least one post-baseline efficacy assessment. | Posted | Mean | 95% Confidence Interval | score on a scale | At week 4, week 12, week 18 and week 24 |
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| Secondary | Rate of Moderate and Severe COPD Exacerbations Over 24 Weeks of Treatment. - Moderate Exacerbations Require Treatment With Systemic Corticosteroids and/or Antibiotics - Severe Exacerbations Require Hospitalisation or Result in Death | This outcome measures the frequency of moderate and severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during the treatment period. A moderate exacerbation is defined as a worsening of respiratory symptoms requiring treatment with systemic corticosteroids, antibiotics, or both, without hospitalization. A severe exacerbation is defined as a worsening of symptoms requiring hospitalization or resulting in death. Exacerbations were recorded from the start of treatment to the final scheduled visit, using data from patient-reported symptom diaries, healthcare provider assessments, and verified medical records. | The Intention-to-Treat (ITT) population included all randomized patients who received at least one dose of study treatment and had at least one post-baseline efficacy assessment. | Posted | Number | 95% Confidence Interval | Exacerbation per year | Over 24 weeks of treatment |
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| Secondary | Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". A SAE is defined as any untoward medical occurrence or effect that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. | Safety population included all randomised patients who received at least one administration of the study treatment. | Posted | Count of Participants | Participants | Over 29 weeks (from Visit 0 to Visit 6) |
|
Adverse events (AEs) were recorded throughout the study, from screening (Day -42), to the end of treatment (Week 24), and up to the final follow-up visit at Week 26±2 weeks. AEs and overall mortality presented here represent the safety set (i.e. all patients receiving any amount of study drug, including both run-ins and randomized patients). As per planned analysis, AEs were collected in a combined manner: i.e. data on the run-in phase were combined with the ones of the reported arms.
An adverse event (AE) was defined as any untoward medical occurrence in a patient administered a medicinal product, regardless of a causal relationship with the treatment. This included any unfavorable and unintended sign, symptom, or disease temporally associated with the investigational drug. AEs were collected from the signing of the informed consent form (ICF) until the end of the study participation.
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 | Run-in and Randomized CHF 1535 100/6 µg pMDI (SAF Population) | Patients in this arm received:
To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. | 2 | 377 | 45 | 377 | 179 | 377 |
| EG001 | Run-in and Randomized Symbicort® Turbohaler® (SAF Population) | Patients in this arm received:
To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. | 3 | 373 | 47 | 373 | 172 | 373 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cor pulmonale chronic | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pterygium | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Remnant gastritis | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Renal artery restenosis | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Lung squamous cell carcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cor pulmonale chronic | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Defect conduction intraventricular | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Degenerative aortic valve disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Right ventricular enlargement | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Panophthalmitis | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pterygium | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coeliac artery stenosis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Sexually transmitted disease carrier | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Animal scratch | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Conjunctival laceration | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Calcium ionised decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Carcinoembryonic antigen increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Electrocardiogram P wave abnormal | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Electrocardiogram ST segment abnormal | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Electrocardiogram ST segment depression | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Lymphocyte percentage decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Monocyte percentage decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Neutrophil percentage increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Occult blood | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary occult blood positive | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bone formation increased | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Senile osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Carotid artery dissection | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebral atrophy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Occipital neuralgia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Device physical property issue | Product Issues | MedDRA 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chyluria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Calculus prostatic | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Scrotal dermatitis | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural thickening | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Subclavian artery stenosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
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 | Jul 29, 2022 | Jan 21, 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 |
|---|---|
| D005581 | Foster Home Care |
| D001507 | Beclomethasone |
| D000068759 | Formoterol Fumarate |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| 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 |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Based on the estimated historical effect, a non-inferiority margin of -0.070 L for the difference between CHF 1535 pMDI and Symbicort® Turbohaler® was specified. |
| OG001 | Symbicort® Turbohaler® - ITT Population | 2 inhalations BID Total Daily Dose = 640/18µg Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo: The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
|
|
|
| OG001 | Symbicort® Turbohaler® - ITT Population | 2 inhalations BID Total Daily Dose = 640/18µg Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo: The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
|
|
|
| OG001 | Symbicort® Turbohaler® - ITT Population | 2 inhalations BID Total Daily Dose = 640/18µg Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo: The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
|
|
|
| OG001 | Symbicort® Turbohaler® - ITT Population | 2 inhalations BID Total Daily Dose = 640/18µg Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo: The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
|
|
|
| OG001 | Symbicort® Turbohaler® - ITT Population | 2 inhalations BID Total Daily Dose = 640/18µg Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo: The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
|
|
|
| OG001 | Symbicort® Turbohaler® - ITT Population | 2 inhalations BID Total Daily Dose = 640/18µg Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo: The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
|
|
|
| OG001 | Symbicort® Turbohaler® - ITT Population | 2 inhalations BID Total Daily Dose = 640/18µg Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo: The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
|
|
|
| OG001 | Symbicort® Turbohaler® - SAF Population | 2 inhalations BID Total Daily Dose = 640/18µg Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo: The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d. |
|
|