Trial Outcomes & Findings for Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma (NCT NCT00941798)
NCT ID: NCT00941798
Last Updated: 2012-08-31
Results Overview
Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.
COMPLETED
PHASE2
2283 participants
Up to 21 months
2012-08-31
Participant Flow
2283 patients were screened. 1518 patients were randomized.
Participant milestones
| Measure |
QMF149 Twisthaler® 500/400
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Overall Study
STARTED
|
755
|
763
|
|
Overall Study
Full Analysis Set
|
749
|
759
|
|
Overall Study
COMPLETED
|
561
|
578
|
|
Overall Study
NOT COMPLETED
|
194
|
185
|
Reasons for withdrawal
| Measure |
QMF149 Twisthaler® 500/400
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
72
|
74
|
|
Overall Study
Adverse Event
|
43
|
23
|
|
Overall Study
Lost to Follow-up
|
29
|
23
|
|
Overall Study
Protocol Violation
|
17
|
20
|
|
Overall Study
Administrative problems
|
13
|
23
|
|
Overall Study
Lack of Efficacy
|
10
|
17
|
|
Overall Study
Patient's inability to use device
|
6
|
1
|
|
Overall Study
Abnormal test procedure results
|
3
|
1
|
|
Overall Study
Abnormal laboratory values
|
1
|
2
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma
Baseline characteristics by cohort
| Measure |
QMF149 Twisthaler® 500/400
n=749 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=759 Participants
Mometasone Twisthaler®, 400 µg QD
|
Total
n=1508 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
42.4 years
STANDARD_DEVIATION 14.75 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 14.58 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 14.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
436 Participants
n=5 Participants
|
449 Participants
n=7 Participants
|
885 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
313 Participants
n=5 Participants
|
310 Participants
n=7 Participants
|
623 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 21 monthsPopulation: Full analysis set: all randomized patients who received at least one dose of study medication.
Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=749 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=759 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Time to First Serious Asthma Exacerbation
|
13.3 months
Interval 0.0 to 19.6
|
13.4 months
Interval 0.0 to 20.3
|
SECONDARY outcome
Timeframe: up to 21 monthsPopulation: Full analysis set: all randomized patients who received at least one dose of study medication.
The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=749 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=759 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: Full analysis set: all randomized patients who received at least one dose of study medication.
Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months).
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=749 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=759 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids
|
124 participants
|
171 participants
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: Full analysis set: all randomized patients who received at least one dose of study medication.
The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) \>= 20% from mean baseline on \>= 3 consecutive days, nighttime symptom score \>= 2 on \>= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) \>=20% from baseline at evening visits, daytime symptom score of 3 or 4 on \>= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use \>= 8 puffs on \>= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms).
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=749 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=759 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Number of Patients With at Least One Asthma Worsening Post-baseline
|
533 participants
|
637 participants
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment\*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=674 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=699 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit
|
0.06 liters
Standard Error 0.025
|
-0.07 liters
Standard Error 0.024
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dosePopulation: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FEV1 data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FEV1 = treatment + visit + treatment\*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=578 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=607 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit
5 minutes post-dose (n = 578, 607)
|
0.09 liters
Standard Error 0.018
|
-0.04 liters
Standard Error 0.018
|
|
Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit
30 minutes post-dose (n = 576, 605)
|
0.12 liters
Standard Error 0.020
|
-0.05 liters
Standard Error 0.020
|
|
Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit
1 hour post-dose (n = 575, 602)
|
0.13 liters
Standard Error 0.021
|
-0.06 liters
Standard Error 0.021
|
|
Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit
2 hours post-dose (n = 568, 601)
|
0.14 liters
Standard Error 0.022
|
-0.05 liters
Standard Error 0.022
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dosePopulation: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FVC data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FVC = treatment + visit + treatment\*visit interaction + baseline FVC + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=578 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=607 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC) at Final Visit
5 minutes post-dose (n = 578, 607)
|
-0.03 liter
Standard Error 0.023
|
-0.11 liter
Standard Error 0.023
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Final Visit
30 minutes post-dose (n = 576, 605)
|
-0.03 liter
Standard Error 0.025
|
-0.13 liter
Standard Error 0.024
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Final Visit
1 hour post-dose (n = 575, 602)
|
-0.01 liter
Standard Error 0.025
|
-0.13 liter
Standard Error 0.025
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Final Visit
2 hours post-dose (n = 568, 601)
|
-0.02 liter
Standard Error 0.026
|
-0.13 liter
Standard Error 0.026
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and at final visit were included in this analysis.
PEF was performed every morning and evening prior to study medication use except evenings on the day of clinic visits. Baseline is average over the last 14 days prior to start of treatment. Analysis of covariance model: change from baseline in PEF = treatment + baseline PEF + region + history of asthma related hospitalization in the past 12 months + history of asthma worsening in the past 12 months + African American patient.
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=731 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=748 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period
Morning PEF (n = 730, 746)
|
0.43 liters per second
Standard Error 0.075
|
0.00 liters per second
Standard Error 0.075
|
|
Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period
Evening PEF (n = 731, 748)
|
0.27 liters per second
Standard Error 0.076
|
-0.15 liters per second
Standard Error 0.075
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=731 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=749 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime
Morning (n = 730, 746)
|
22.3 percentage of days
Standard Error 2.17
|
18.4 percentage of days
Standard Error 2.17
|
|
Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime
Daytime (n = 731, 749)
|
27.1 percentage of days
Standard Error 2.96
|
19.5 percentage of days
Standard Error 2.95
|
|
Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime
Nighttime (n = 730, 746)
|
23.6 percentage of days
Standard Error 2.69
|
17.3 percentage of days
Standard Error 2.68
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and endpoint were included in this analysis.
Total asthma symptom score = morning symptoms (0, 1) + daytime score (0-4) + nighttime score (0-4). The range is from 0 to 9. A lower number indicates improvement. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=731 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=749 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime
Total (n = 708, 733)
|
-1.22 units on a scale
Standard Error 0.088
|
-0.94 units on a scale
Standard Error 0.088
|
|
Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime
Daytime (n = 731, 749)
|
-0.50 units on a scale
Standard Error 0.043
|
-0.39 units on a scale
Standard Error 0.043
|
|
Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime
Nighttime (n = 730, 746)
|
-0.46 units on a scale
Standard Error 0.037
|
-0.36 units on a scale
Standard Error 0.037
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
24 hours consists of both 12 hour daytime and 12 hour nighttime. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=692 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=711 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime
24 hours (n = 669, 696)
|
29.1 percentage of days
Standard Error 2.88
|
17.9 percentage of days
Standard Error 2.88
|
|
Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime
Daytime (n = 692, 711)
|
23.6 percentage of days
Standard Error 2.74
|
13.8 percentage of days
Standard Error 2.74
|
|
Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime
Nighttime (n = 691, 708)
|
24.6 percentage of days
Standard Error 2.69
|
14.5 percentage of days
Standard Error 2.68
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)Population: Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.
The Asthma Control Questionnaire score ranges from 0 (good control of asthma) to 6 (poor control of asthma). A negative change in score indicates improvement in asthma control. Repeated measures of analysis of covariance model: change from baseline in ACQ score = treatment + visit + treatment\*visit interaction + baseline ACQ score + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.
Outcome measures
| Measure |
QMF149 Twisthaler® 500/400
n=675 Participants
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=687 Participants
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit
|
-0.55 units on a scale
Standard Error 0.052
|
-0.32 units on a scale
Standard Error 0.052
|
Adverse Events
QMF149 Twisthaler® 500/400
Mometasone Twisthaler®
Serious adverse events
| Measure |
QMF149 Twisthaler® 500/400
n=749 participants at risk
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=759 participants at risk
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.13%
1/749
|
0.00%
0/759
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/749
|
0.13%
1/759
|
|
Cardiac disorders
Angina unstable
|
0.13%
1/749
|
0.00%
0/759
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/749
|
0.13%
1/759
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/749
|
0.13%
1/759
|
|
Cardiac disorders
Coronary artery disease
|
0.13%
1/749
|
0.00%
0/759
|
|
Cardiac disorders
Myocardial ischaemia
|
0.13%
1/749
|
0.00%
0/759
|
|
Cardiac disorders
Palpitations
|
0.00%
0/749
|
0.13%
1/759
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/749
|
0.13%
1/759
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.13%
1/749
|
0.13%
1/759
|
|
Eye disorders
Eye haemorrhage
|
0.13%
1/749
|
0.00%
0/759
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.13%
1/749
|
0.00%
0/759
|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
1/749
|
0.00%
0/759
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/749
|
0.13%
1/759
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/749
|
0.26%
2/759
|
|
Gastrointestinal disorders
Nausea
|
0.27%
2/749
|
0.00%
0/759
|
|
Gastrointestinal disorders
Pancreatitis
|
0.13%
1/749
|
0.00%
0/759
|
|
Gastrointestinal disorders
Vomiting
|
0.27%
2/749
|
0.00%
0/759
|
|
General disorders
Chest pain
|
0.13%
1/749
|
0.26%
2/759
|
|
General disorders
Cyst
|
0.00%
0/749
|
0.13%
1/759
|
|
General disorders
Multi-organ failure
|
0.00%
0/749
|
0.13%
1/759
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/749
|
0.26%
2/759
|
|
General disorders
Pyrexia
|
0.13%
1/749
|
0.00%
0/759
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.13%
1/749
|
0.00%
0/759
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.27%
2/749
|
0.00%
0/759
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/749
|
0.13%
1/759
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/749
|
0.13%
1/759
|
|
Infections and infestations
Appendicitis
|
0.27%
2/749
|
0.26%
2/759
|
|
Infections and infestations
Cellulitis
|
0.13%
1/749
|
0.00%
0/759
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/749
|
0.26%
2/759
|
|
Infections and infestations
External ear cellulitis
|
0.00%
0/749
|
0.13%
1/759
|
|
Infections and infestations
Gastroenteritis
|
0.13%
1/749
|
0.00%
0/759
|
|
Infections and infestations
Malaria
|
0.13%
1/749
|
0.00%
0/759
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/749
|
0.13%
1/759
|
|
Infections and infestations
Pneumonia
|
0.00%
0/749
|
0.53%
4/759
|
|
Infections and infestations
Septic shock
|
0.00%
0/749
|
0.13%
1/759
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
1/749
|
0.00%
0/759
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/749
|
0.13%
1/759
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/749
|
0.13%
1/759
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/749
|
0.13%
1/759
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.13%
1/749
|
0.00%
0/759
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.13%
1/749
|
0.00%
0/759
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.13%
1/749
|
0.00%
0/759
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.13%
1/749
|
0.00%
0/759
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.13%
1/749
|
0.00%
0/759
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/749
|
0.13%
1/759
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/749
|
0.13%
1/759
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/749
|
0.13%
1/759
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/749
|
0.13%
1/759
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.13%
1/749
|
0.00%
0/759
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/749
|
0.13%
1/759
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/749
|
0.13%
1/759
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/749
|
0.13%
1/759
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.13%
1/749
|
0.00%
0/759
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.13%
1/749
|
0.00%
0/759
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/749
|
0.13%
1/759
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteochondroma
|
0.00%
0/749
|
0.13%
1/759
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.13%
1/749
|
0.00%
0/759
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.13%
1/749
|
0.13%
1/759
|
|
Nervous system disorders
Carotid artery occlusion
|
0.13%
1/749
|
0.00%
0/759
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/749
|
0.13%
1/759
|
|
Nervous system disorders
Radicular pain
|
0.13%
1/749
|
0.00%
0/759
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/749
|
0.13%
1/759
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/749
|
0.13%
1/759
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.40%
3/749
|
0.13%
1/759
|
|
Psychiatric disorders
Abnormal behaviour
|
0.13%
1/749
|
0.00%
0/759
|
|
Reproductive system and breast disorders
Colpocele
|
0.00%
0/749
|
0.13%
1/759
|
|
Reproductive system and breast disorders
Endometriosis
|
0.13%
1/749
|
0.00%
0/759
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.13%
1/749
|
0.00%
0/759
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.27%
2/749
|
1.2%
9/759
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/749
|
0.13%
1/759
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/749
|
0.26%
2/759
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.13%
1/749
|
0.00%
0/759
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.13%
1/749
|
0.00%
0/759
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.13%
1/749
|
0.00%
0/759
|
|
Vascular disorders
Aortic aneurysm
|
0.13%
1/749
|
0.00%
0/759
|
Other adverse events
| Measure |
QMF149 Twisthaler® 500/400
n=749 participants at risk
QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
|
Mometasone Twisthaler®
n=759 participants at risk
Mometasone Twisthaler®, 400 µg QD
|
|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.6%
12/749
|
1.1%
8/759
|
|
General disorders
Pyrexia
|
1.2%
9/749
|
1.8%
14/759
|
|
Infections and infestations
Acute sinusitis
|
2.1%
16/749
|
1.1%
8/759
|
|
Infections and infestations
Bronchitis
|
5.2%
39/749
|
7.6%
58/759
|
|
Infections and infestations
Influenza
|
3.5%
26/749
|
3.6%
27/759
|
|
Infections and infestations
Laryngitis
|
0.67%
5/749
|
1.6%
12/759
|
|
Infections and infestations
Lower respiratory tract infection
|
1.7%
13/749
|
1.2%
9/759
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
112/749
|
14.0%
106/759
|
|
Infections and infestations
Pharyngitis
|
3.9%
29/749
|
3.6%
27/759
|
|
Infections and infestations
Respiratory tract infection
|
1.7%
13/749
|
2.0%
15/759
|
|
Infections and infestations
Rhinitis
|
2.8%
21/749
|
1.8%
14/759
|
|
Infections and infestations
Sinusitis
|
7.3%
55/749
|
6.9%
52/759
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
83/749
|
12.6%
96/759
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
2.0%
15/749
|
2.8%
21/759
|
|
Infections and infestations
Urinary tract infection
|
1.9%
14/749
|
1.8%
14/759
|
|
Infections and infestations
Viral infection
|
1.3%
10/749
|
3.2%
24/759
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.9%
29/749
|
4.7%
36/759
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
16/749
|
1.4%
11/759
|
|
Nervous system disorders
Headache
|
3.5%
26/749
|
4.0%
30/759
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
26.0%
195/749
|
35.4%
269/759
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.5%
266/749
|
8.3%
63/759
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.6%
12/749
|
1.7%
13/759
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
24/749
|
2.4%
18/759
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.9%
29/749
|
3.3%
25/759
|
|
Vascular disorders
Hypertension
|
1.7%
13/749
|
1.8%
14/759
|
Additional Information
Study Director
Novartis Pharmaceuticals
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.
- Publication restrictions are in place
Restriction type: OTHER