Trial Outcomes & Findings for Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma (NCT NCT02892344)
NCT ID: NCT02892344
Last Updated: 2026-01-13
Results Overview
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.
COMPLETED
PHASE3
802 participants
week 12
2026-01-13
Participant Flow
Participant milestones
| Measure |
QMF149 150/80 μg
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Overall Study
STARTED
|
398
|
404
|
|
Overall Study
Full analysis set
|
395
|
399
|
|
Overall Study
COMPLETED
|
394
|
383
|
|
Overall Study
NOT COMPLETED
|
4
|
21
|
Reasons for withdrawal
| Measure |
QMF149 150/80 μg
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Overall Study
Protocol deviation
|
3
|
4
|
|
Overall Study
Adverse Event
|
1
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Non-compliance with study treatment
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Subject/guardian decision
|
0
|
4
|
|
Overall Study
Technical problems
|
0
|
1
|
Baseline Characteristics
Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma
Baseline characteristics by cohort
| Measure |
QMF149 150/80 μg
n=398 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=404 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
Total
n=802 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.1 Years
STANDARD_DEVIATION 16.26 • n=210 Participants
|
45.1 Years
STANDARD_DEVIATION 16.27 • n=19 Participants
|
45.6 Years
STANDARD_DEVIATION 16.26 • n=123 Participants
|
|
Sex: Female, Male
Female
|
247 Participants
n=210 Participants
|
241 Participants
n=19 Participants
|
488 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=210 Participants
|
163 Participants
n=19 Participants
|
314 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
98 Participants
n=210 Participants
|
101 Participants
n=19 Participants
|
199 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=210 Participants
|
5 Participants
n=19 Participants
|
6 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
262 Participants
n=210 Participants
|
265 Participants
n=19 Participants
|
527 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
37 Participants
n=210 Participants
|
33 Participants
n=19 Participants
|
70 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: week 12Population: 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.
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.
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Trough FEV1
|
2.562 Liters
Standard Error 0.0134
|
2.379 Liters
Standard Error 0.0134
|
SECONDARY outcome
Timeframe: week 12Population: 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.
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.
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
ACQ-7
|
1.323 Units on a scale
Standard Error 0.0411
|
1.540 Units on a scale
Standard Error 0.0411
|
SECONDARY outcome
Timeframe: Day 2Population: 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
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
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Trough FEV1 at Day 2
|
2.490 Liters
Standard Error 0.0108
|
2.358 Liters
Standard Error 0.0108
|
SECONDARY outcome
Timeframe: week 4Population: 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
Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Pre-dose FEV1 at Week 4
|
2.545 Liters
Standard Error 0.0132
|
2.369 Liters
Standard Error 0.0131
|
SECONDARY outcome
Timeframe: week 12Population: 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
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
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
FVC Over 12 Weeks
Pre dose trough FVC (n=383,379)
|
3.453 Liters
Standard Error 0.0169
|
3.353 Liters
Standard Error 0.0169
|
|
FVC Over 12 Weeks
Pre-dose trough FEF25-75% (n=383,379)
|
2.030 Liters
Standard Error 0.0228
|
1.742 Liters
Standard Error 0.0228
|
SECONDARY outcome
Timeframe: week 12Population: 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
Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
PEF Over 4 and 12 Weeks
Mean Evening PEF (n=386,386)
|
26.8 L/min
Standard Error 1.84
|
0.7 L/min
Standard Error 1.84
|
|
PEF Over 4 and 12 Weeks
Mean Morning PEF (n=382,382)
|
31.0 L/min
Standard Error 1.98
|
3.8 L/min
Standard Error 1.97
|
SECONDARY outcome
Timeframe: week 12Population: 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
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.
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Percentage of Patients With ACQ-7 MID at Week 12
|
74.7 Percentage
|
64.9 Percentage
|
SECONDARY outcome
Timeframe: week 12Population: 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
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
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Daily E-diary Over 12 Weeks
% of mornings with no symptoms on awakening
|
14.7 Percentage
Standard Error 1.53
|
11.2 Percentage
Standard Error 1.53
|
|
Daily E-diary Over 12 Weeks
% of asthma symptom-free days
|
17.1 Percentage
Standard Error 1.68
|
14.4 Percentage
Standard Error 1.65
|
|
Daily E-diary Over 12 Weeks
% of nights with no night-time awakenings
|
13.4 Percentage
Standard Error 1.37
|
8.7 Percentage
Standard Error 1.36
|
SECONDARY outcome
Timeframe: week 4Population: 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
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
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
ACQ-7 at Week 4
|
1.454 Units on a scale
Standard Error 0.0408
|
1.658 Units on a scale
Standard Error 0.0406
|
SECONDARY outcome
Timeframe: week 12Population: 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
Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary recordings over 12 weeks of treatment
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Rescue Medication Use Over 12 Weeks
Night-time number of puffs of rescue medication
|
-0.26 Number of puffs of rescue medication
Standard Error 0.025
|
-0.16 Number of puffs of rescue medication
Standard Error 0.025
|
|
Rescue Medication Use Over 12 Weeks
Daytime number of puffs of rescue medication
|
-0.39 Number of puffs of rescue medication
Standard Error 0.033
|
-0.24 Number of puffs of rescue medication
Standard Error 0.032
|
SECONDARY outcome
Timeframe: week 12Population: 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
Percentage of rescue medication free days over 12 weeks of treatment period
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Percentage of Rescue Medication Free Days Over 12 Weeks
|
22.2 Percentage
Standard Error 1.81
|
14.1 Percentage
Standard Error 1.80
|
SECONDARY outcome
Timeframe: week 12Population: 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
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.
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12
|
5.779 Score
Standard Error 0.0475
|
5.630 Score
Standard Error 0.0473
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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.
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Number of Patients With Asthma Exacerbation Over 12 Weeks
Mild asthma exacerbation
|
11 Number of patients
|
29 Number of patients
|
|
Number of Patients With Asthma Exacerbation Over 12 Weeks
Moderate asthma exacerbation
|
7 Number of patients
|
23 Number of patients
|
|
Number of Patients With Asthma Exacerbation Over 12 Weeks
Severe asthma exacerbation
|
3 Number of patients
|
11 Number of patients
|
|
Number of Patients With Asthma Exacerbation Over 12 Weeks
Moderate or severe asthma exacerbation
|
10 Number of patients
|
32 Number of patients
|
SECONDARY outcome
Timeframe: Week 12Population: 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
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
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
Moderate or severe asthma exacerbation
|
0.08 Number of exacerbation
|
0.31 Number of exacerbation
|
|
The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
All (mild, moderate, severe) asthma exacerbation
|
0.20 Number of exacerbation
|
0.67 Number of exacerbation
|
SECONDARY outcome
Timeframe: Week 12Population: 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
The annual rate of asthma exacerbations were analyzed using a generalized linear model.
Outcome measures
| Measure |
QMF149 150/80 μg
n=395 Participants
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200 µg
n=399 Participants
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
|
10 Count of participants
|
32 Count of participants
|
Adverse Events
QMF149 150/80
MF 200
Serious adverse events
| Measure |
QMF149 150/80
n=396 participants at risk
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200
n=399 participants at risk
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/396 • 12 weeks
AE additional description
|
0.50%
2/399 • 12 weeks
AE additional description
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/396 • 12 weeks
AE additional description
|
0.25%
1/399 • 12 weeks
AE additional description
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/396 • 12 weeks
AE additional description
|
0.25%
1/399 • 12 weeks
AE additional description
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/396 • 12 weeks
AE additional description
|
0.25%
1/399 • 12 weeks
AE additional description
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/396 • 12 weeks
AE additional description
|
0.25%
1/399 • 12 weeks
AE additional description
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.25%
1/396 • 12 weeks
AE additional description
|
0.00%
0/399 • 12 weeks
AE additional description
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/396 • 12 weeks
AE additional description
|
0.25%
1/399 • 12 weeks
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/396 • 12 weeks
AE additional description
|
0.25%
1/399 • 12 weeks
AE additional description
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.25%
1/396 • 12 weeks
AE additional description
|
0.00%
0/399 • 12 weeks
AE additional description
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.25%
1/396 • 12 weeks
AE additional description
|
0.00%
0/399 • 12 weeks
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.25%
1/396 • 12 weeks
AE additional description
|
0.25%
1/399 • 12 weeks
AE additional description
|
|
Gastrointestinal disorders
Appendix disorder
|
0.00%
0/396 • 12 weeks
AE additional description
|
0.25%
1/399 • 12 weeks
AE additional description
|
|
Gastrointestinal disorders
Dental cyst
|
0.25%
1/396 • 12 weeks
AE additional description
|
0.00%
0/399 • 12 weeks
AE additional description
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/396 • 12 weeks
AE additional description
|
0.25%
1/399 • 12 weeks
AE additional description
|
|
Infections and infestations
Abscess oral
|
0.25%
1/396 • 12 weeks
AE additional description
|
0.00%
0/399 • 12 weeks
AE additional description
|
Other adverse events
| Measure |
QMF149 150/80
n=396 participants at risk
QMF149 150/80 microgram o.d. delivered via Concept1
|
MF 200
n=399 participants at risk
MF 200 microgram o.d. delivered via Twisthaler®
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
0.25%
1/396 • 12 weeks
AE additional description
|
1.3%
5/399 • 12 weeks
AE additional description
|
|
Infections and infestations
Influenza
|
1.0%
4/396 • 12 weeks
AE additional description
|
1.0%
4/399 • 12 weeks
AE additional description
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
17/396 • 12 weeks
AE additional description
|
4.8%
19/399 • 12 weeks
AE additional description
|
|
Infections and infestations
Pharyngitis
|
1.3%
5/396 • 12 weeks
AE additional description
|
0.50%
2/399 • 12 weeks
AE additional description
|
|
Infections and infestations
Sinusitis
|
1.3%
5/396 • 12 weeks
AE additional description
|
1.3%
5/399 • 12 weeks
AE additional description
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
4/396 • 12 weeks
AE additional description
|
2.5%
10/399 • 12 weeks
AE additional description
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.25%
1/396 • 12 weeks
AE additional description
|
1.3%
5/399 • 12 weeks
AE additional description
|
|
Injury, poisoning and procedural complications
Overdose
|
1.3%
5/396 • 12 weeks
AE additional description
|
2.5%
10/399 • 12 weeks
AE additional description
|
|
Nervous system disorders
Headache
|
1.0%
4/396 • 12 weeks
AE additional description
|
2.3%
9/399 • 12 weeks
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.1%
20/396 • 12 weeks
AE additional description
|
15.0%
60/399 • 12 weeks
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
5/396 • 12 weeks
AE additional description
|
1.0%
4/399 • 12 weeks
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.3%
5/396 • 12 weeks
AE additional description
|
0.50%
2/399 • 12 weeks
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/396 • 12 weeks
AE additional description
|
1.0%
4/399 • 12 weeks
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.0%
4/396 • 12 weeks
AE additional description
|
0.00%
0/399 • 12 weeks
AE additional description
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER