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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000472-22 | EudraCT Number |
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The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d.
delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.
The primary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. The key secondary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QMF149 150/80 μg | Experimental | QMF149 150/80 microgram o.d. delivered via Concept1 |
|
| MF 200 µg | Active Comparator | MF 200 microgram o.d. delivered via Twisthaler® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QMF149 150/80 μg | Drug | QMF149 150/80 μg o.d via Concept1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 | demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| ACQ-7 | ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. the ACQ-7 was used to assess improvements in asthma symptom control. The ACQ-7, a seven-item disease-specific instrument developed and validated to assess asthma control in patients in clinical trials as well as in individuals in clinical practice, was provided to the site. All seven items were then scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating no control. The questions were equally weighted and the total score was the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the patient while the last question (question 7) was completed by the study investigator using spirometry data generated by the spirometry equipment. |
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Inclusion Criteria:
Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (inadequately controlled).
Exclusion Criteria:
Patients who have smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year.
Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization (> 24 hours) or emergency room visit (≤ 24 hours) as follows:
For adults: within 6 weeks of Screening Visit. If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation
For adolescents: Severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR hospitalization (> 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR emergency room visit (≤ 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids within the last 6 months.
Patients who ever required intubation for a severe asthma attack/exacerbation
Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigator's medical judgment )
Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
Patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study.
Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
Patients with Type I diabetes or uncontrolled Type II diabetes.
Patients with narcolepsy and/or insomnia.
Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bulgaria | Bulgaria | Bulgaria | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36472162 | Derived | Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| ID | Title | Description |
|---|---|---|
| FG000 | QMF149 150/80 μg | QMF149 150/80 microgram o.d. delivered via Concept1 |
| FG001 | MF 200 µg | MF 200 microgram o.d. delivered via Twisthaler® |
| 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 20, 2018 | May 29, 2019 |
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| MF 200 μg | Drug | MF 200 μg o.d. via Twisthaler® |
|
|
| week 12 |
| Trough FEV1 at Day 2 | Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing | Day 2 |
| Pre-dose FEV1 at Week 4 | Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose | week 4 |
| FVC Over 12 Weeks | FVC is the total amount of air exhaled during the FEV test. Forced Vital Capacity (FVC) and Forced Expiratory Flow between 25% and 75% of FVC (FEF25-75) will be measured | week 12 |
| PEF Over 4 and 12 Weeks | Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration | week 12 |
| Percentage of Patients With ACQ-7 MID at Week 12 | MID is Minimum Important Difference. ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. Percent of patients achieving the minimal important difference (MID) in ACQ-7 (i.e. at least 0.5 decrease from baseline) will be measured. | week 12 |
| Daily E-diary Over 12 Weeks | Percentage of asthma symptoms free days, the percentage of nights without nighttime awakenings, and the percentage of mornings without symptoms on awakening as recorded by daily electronic Diary (e-Diary) over 12 weeks of treatment | week 12 |
| ACQ-7 at Week 4 | ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control | week 4 |
| Rescue Medication Use Over 12 Weeks | Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary recordings over 12 weeks of treatment | week 12 |
| Percentage of Rescue Medication Free Days Over 12 Weeks | Percentage of rescue medication free days over 12 weeks of treatment period | week 12 |
| Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12 | The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score. | week 12 |
| Number of Patients With Asthma Exacerbation Over 12 Weeks | The exacerbation categories are: mild, moderate, severe and the combination of moderate or severe. Time to first asthma exacerbation by exacerbation category. Annual rate of asthma exacerbations by exacerbation category. | Week 12 |
| The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period | Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS (Systemic Corticosteroids) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations | Week 12 |
| Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period | The annual rate of asthma exacerbations were analyzed using a generalized linear model. | Week 12 |
| Stara Zagora |
| Bulgaria |
| 6000 |
| Bulgaria |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
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| A Pediatric Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
| Full analysis set |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QMF149 150/80 μg | QMF149 150/80 microgram o.d. delivered via Concept1 |
| BG001 | MF 200 µg | MF 200 microgram o.d. delivered via Twisthaler® |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | 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 | Trough FEV1 | demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry. | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables. | Posted | Least Squares Mean | Standard Error | Liters | week 12 |
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| Secondary | ACQ-7 | ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. the ACQ-7 was used to assess improvements in asthma symptom control. The ACQ-7, a seven-item disease-specific instrument developed and validated to assess asthma control in patients in clinical trials as well as in individuals in clinical practice, was provided to the site. All seven items were then scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating no control. The questions were equally weighted and the total score was the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the patient while the last question (question 7) was completed by the study investigator using spirometry data generated by the spirometry equipment. | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables. | Posted | Least Squares Mean | Standard Error | Units on a scale | week 12 |
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| Secondary | Trough FEV1 at Day 2 | Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Least Squares Mean | Standard Error | Liters | Day 2 |
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| Secondary | Pre-dose FEV1 at Week 4 | Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Least Squares Mean | Standard Error | Liters | week 4 |
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| Secondary | FVC Over 12 Weeks | FVC is the total amount of air exhaled during the FEV test. Forced Vital Capacity (FVC) and Forced Expiratory Flow between 25% and 75% of FVC (FEF25-75) will be measured | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Least Squares Mean | Standard Error | Liters | week 12 |
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| Secondary | PEF Over 4 and 12 Weeks | Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Least Squares Mean | Standard Error | L/min | week 12 |
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| Secondary | Percentage of Patients With ACQ-7 MID at Week 12 | MID is Minimum Important Difference. ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. Percent of patients achieving the minimal important difference (MID) in ACQ-7 (i.e. at least 0.5 decrease from baseline) will be measured. | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Number | Percentage | week 12 |
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| Secondary | Daily E-diary Over 12 Weeks | Percentage of asthma symptoms free days, the percentage of nights without nighttime awakenings, and the percentage of mornings without symptoms on awakening as recorded by daily electronic Diary (e-Diary) over 12 weeks of treatment | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Least Squares Mean | Standard Error | Percentage | week 12 |
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| Secondary | ACQ-7 at Week 4 | ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Least Squares Mean | Standard Error | Units on a scale | week 4 |
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| Secondary | Rescue Medication Use Over 12 Weeks | Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary recordings over 12 weeks of treatment | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Least Squares Mean | Standard Error | Number of puffs of rescue medication | week 12 |
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| Secondary | Percentage of Rescue Medication Free Days Over 12 Weeks | Percentage of rescue medication free days over 12 weeks of treatment period | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Least Squares Mean | Standard Error | Percentage | week 12 |
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| Secondary | Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12 | The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score. | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Least Squares Mean | Standard Error | Score | week 12 |
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| Secondary | Number of Patients With Asthma Exacerbation Over 12 Weeks | The exacerbation categories are: mild, moderate, severe and the combination of moderate or severe. Time to first asthma exacerbation by exacerbation category. Annual rate of asthma exacerbations by exacerbation category. | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Number | Number of patients | Week 12 |
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| Secondary | The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period | Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS (Systemic Corticosteroids) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Number | Number of exacerbation | Week 12 |
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| Secondary | Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period | The annual rate of asthma exacerbations were analyzed using a generalized linear model. | The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables | Posted | Number | Count of participants | Week 12 |
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12 weeks
AE additional description
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 | QMF149 150/80 | QMF149 150/80 microgram o.d. delivered via Concept1 | 0 | 396 | 5 | 396 | 69 | 396 |
| EG001 | MF 200 | MF 200 microgram o.d. delivered via Twisthaler® | 0 | 399 | 7 | 399 | 106 | 399 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendix disorder | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dental cyst | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 2, 2019 | May 29, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000600413 | QMF149 |
| C510790 | indacaterol |
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
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