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Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02892344
Recruitment Status : Completed
First Posted : September 8, 2016
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Mild Asthma
Interventions Drug: QMF149 150/80 μg
Drug: MF 200 μg
Enrollment 802
Recruitment Details  
Pre-assignment Details  
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description QMF149 150/80 microgram o.d. delivered via Concept1 MF 200 microgram o.d. delivered via Twisthaler®
Period Title: Overall Study
Started 398 404
Full Analysis Set 395 399
Completed 394 383
Not Completed 4 21
Reason Not Completed
Protocol deviation             3             4
Adverse Event             1             8
Lost to Follow-up             0             1
Non-compliance with study treatment             0             1
Physician Decision             0             2
Subject/guardian decision             0             4
Technical problems             0             1
Arm/Group Title QMF149 150/80 μg MF 200 µg Total
Hide Arm/Group Description QMF149 150/80 microgram o.d. delivered via Concept1 MF 200 microgram o.d. delivered via Twisthaler® Total of all reporting groups
Overall Number of Baseline Participants 398 404 802
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 398 participants 404 participants 802 participants
46.1  (16.26) 45.1  (16.27) 45.6  (16.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 398 participants 404 participants 802 participants
Female
247
  62.1%
241
  59.7%
488
  60.8%
Male
151
  37.9%
163
  40.3%
314
  39.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 398 participants 404 participants 802 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
98
  24.6%
101
  25.0%
199
  24.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.3%
5
   1.2%
6
   0.7%
White
262
  65.8%
265
  65.6%
527
  65.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
37
   9.3%
33
   8.2%
70
   8.7%
1.Primary Outcome
Title Trough FEV1
Hide Description 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.
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Least Squares Mean (Standard Error)
Unit of Measure: Liters
2.562  (0.0134) 2.379  (0.0134)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.182
Confidence Interval (2-Sided) 95%
0.148 to 0.217
Estimation Comments [Not Specified]
2.Secondary Outcome
Title ACQ-7
Hide Description 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.
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.323  (0.0411) 1.540  (0.0411)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.218
Confidence Interval (2-Sided) 95%
-0.293 to -0.143
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Trough FEV1 at Day 2
Hide Description 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
Time Frame Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Least Squares Mean (Standard Error)
Unit of Measure: Liters
2.490  (0.0108) 2.358  (0.0108)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.132
Confidence Interval (2-Sided) 95%
0.105 to 0.158
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Pre-dose FEV1 at Week 4
Hide Description Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Least Squares Mean (Standard Error)
Unit of Measure: Liters
2.545  (0.0132) 2.369  (0.0131)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.176
Confidence Interval (2-Sided) 95%
0.145 to 0.207
Estimation Comments [Not Specified]
5.Secondary Outcome
Title FVC Over 12 Weeks
Hide Description 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
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Pre dose trough FVC (n=383,379) Number Analyzed 383 participants 379 participants
3.453  (0.0169) 3.353  (0.0169)
Pre-dose trough FEF25-75% (n=383,379) Number Analyzed 383 participants 379 participants
2.030  (0.0228) 1.742  (0.0228)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments Pre-dose trough FVC
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.100
Confidence Interval (2-Sided) 95%
0.061 to 0.139
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments Pre-dose trough FEF25-75%
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.288
Confidence Interval (2-Sided) 95%
0.231 to 0.345
Estimation Comments [Not Specified]
6.Secondary Outcome
Title PEF Over 4 and 12 Weeks
Hide Description Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Least Squares Mean (Standard Error)
Unit of Measure: L/min
Mean Morning PEF (n=382,382) Number Analyzed 382 participants 382 participants
31.0  (1.98) 3.8  (1.97)
Mean Evening PEF (n=386,386) Number Analyzed 386 participants 386 participants
26.8  (1.84) 0.7  (1.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments Mean Morning PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 27.2
Confidence Interval (2-Sided) 95%
22.1 to 32.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments Mean Evening PEF
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 26.1
Confidence Interval (2-Sided) 95%
21.0 to 31.2
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Patients With ACQ-7 MID at Week 12
Hide Description 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.
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Measure Type: Number
Unit of Measure: Percentage
74.7 64.9
8.Secondary Outcome
Title Daily E-diary Over 12 Weeks
Hide Description 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
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Least Squares Mean (Standard Error)
Unit of Measure: Percentage
% of nights with no night-time awakenings Number Analyzed 384 participants 384 participants
13.4  (1.37) 8.7  (1.36)
% of mornings with no symptoms on awakening Number Analyzed 384 participants 384 participants
14.7  (1.53) 11.2  (1.53)
% of asthma symptom-free days Number Analyzed 373 participants 380 participants
17.1  (1.68) 14.4  (1.65)
9.Secondary Outcome
Title ACQ-7 at Week 4
Hide Description 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
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.454  (0.0408) 1.658  (0.0406)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.204
Confidence Interval (2-Sided) 95%
-0.277 to -0.131
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Rescue Medication Use Over 12 Weeks
Hide Description Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary recordings over 12 weeks of treatment
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Least Squares Mean (Standard Error)
Unit of Measure: Number of puffs of rescue medication
Night-time number of puffs of rescue medication Number Analyzed 384 participants 384 participants
-0.26  (0.025) -0.16  (0.025)
Daytime number of puffs of rescue medication Number Analyzed 388 participants 389 participants
-0.39  (0.033) -0.24  (0.032)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments Night-time number of puffs of rescue medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.16 to -0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments Daytime number of puffs of rescue medication
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.22 to -0.08
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Rescue Medication Free Days Over 12 Weeks
Hide Description Percentage of rescue medication free days over 12 weeks of treatment period
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Least Squares Mean (Standard Error)
Unit of Measure: Percentage
22.2  (1.81) 14.1  (1.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
4.3 to 11.8
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12
Hide Description 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.
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Least Squares Mean (Standard Error)
Unit of Measure: Score
5.779  (0.0475) 5.630  (0.0473)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.149
Confidence Interval (2-Sided) 95%
0.064 to 0.234
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Patients With Asthma Exacerbation Over 12 Weeks
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Measure Type: Number
Unit of Measure: Number of patients
Mild asthma exacerbation 11 29
Moderate asthma exacerbation 7 23
Severe asthma exacerbation 3 11
Moderate or severe asthma exacerbation 10 32
14.Secondary Outcome
Title The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
Hide Description 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
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Measure Type: Number
Unit of Measure: Number of exacerbation
Moderate or severe asthma exacerbation Number Analyzed 394 participants 397 participants
0.08 0.31
All (mild, moderate, severe) asthma exacerbation Number Analyzed 394 participants 397 participants
0.20 0.67
15.Secondary Outcome
Title Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
Hide Description The annual rate of asthma exacerbations were analyzed using a generalized linear model.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title QMF149 150/80 μg MF 200 µg
Hide Arm/Group Description:
QMF149 150/80 microgram o.d. delivered via Concept1
MF 200 microgram o.d. delivered via Twisthaler®
Overall Number of Participants Analyzed 395 399
Measure Type: Number
Unit of Measure: Count of participants
10 32
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QMF149 150/80 μg, MF 200 µg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
0.14 to 0.59
Estimation Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description AE additional description
 
Arm/Group Title QMF149 150/80 MF 200
Hide Arm/Group Description QMF149 150/80 microgram o.d. delivered via Concept1 MF 200 microgram o.d. delivered via Twisthaler®
All-Cause Mortality
QMF149 150/80 MF 200
Affected / at Risk (%) Affected / at Risk (%)
Total   0/396 (0.00%)   0/399 (0.00%) 
Hide Serious Adverse Events
QMF149 150/80 MF 200
Affected / at Risk (%) Affected / at Risk (%)
Total   5/396 (1.26%)   7/399 (1.75%) 
Gastrointestinal disorders     
Appendix disorder  1  0/396 (0.00%)  1/399 (0.25%) 
Dental cyst  1  1/396 (0.25%)  0/399 (0.00%) 
Hepatobiliary disorders     
Autoimmune hepatitis  1  0/396 (0.00%)  1/399 (0.25%) 
Infections and infestations     
Abscess oral  1  1/396 (0.25%)  0/399 (0.00%) 
Bronchitis  1  0/396 (0.00%)  2/399 (0.50%) 
Urinary tract infection  1  0/396 (0.00%)  1/399 (0.25%) 
Viral upper respiratory tract infection  1  0/396 (0.00%)  1/399 (0.25%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/396 (0.00%)  1/399 (0.25%) 
Fibula fracture  1  0/396 (0.00%)  1/399 (0.25%) 
Incisional hernia  1  1/396 (0.25%)  0/399 (0.00%) 
Tibia fracture  1  0/396 (0.00%)  1/399 (0.25%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/396 (0.00%)  1/399 (0.25%) 
Osteoarthritis  1  1/396 (0.25%)  0/399 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer  1  1/396 (0.25%)  0/399 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/396 (0.25%)  1/399 (0.25%) 
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
QMF149 150/80 MF 200
Affected / at Risk (%) Affected / at Risk (%)
Total   69/396 (17.42%)   106/399 (26.57%) 
Infections and infestations     
Bronchitis  1  1/396 (0.25%)  5/399 (1.25%) 
Influenza  1  4/396 (1.01%)  4/399 (1.00%) 
Nasopharyngitis  1  17/396 (4.29%)  19/399 (4.76%) 
Pharyngitis  1  5/396 (1.26%)  2/399 (0.50%) 
Sinusitis  1  5/396 (1.26%)  5/399 (1.25%) 
Upper respiratory tract infection  1  4/396 (1.01%)  10/399 (2.51%) 
Viral upper respiratory tract infection  1  1/396 (0.25%)  5/399 (1.25%) 
Injury, poisoning and procedural complications     
Overdose  1  5/396 (1.26%)  10/399 (2.51%) 
Nervous system disorders     
Headache  1  4/396 (1.01%)  9/399 (2.26%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  20/396 (5.05%)  60/399 (15.04%) 
Cough  1  5/396 (1.26%)  4/399 (1.00%) 
Dysphonia  1  5/396 (1.26%)  2/399 (0.50%) 
Dyspnoea  1  0/396 (0.00%)  4/399 (1.00%) 
Rhinitis allergic  1  4/396 (1.01%)  0/399 (0.00%) 
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02892344    
Other Study ID Numbers: CQVM149B2303
2016-000472-22 ( EudraCT Number )
First Submitted: August 29, 2016
First Posted: September 8, 2016
Results First Submitted: May 29, 2019
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019