Trial Outcomes & Findings for A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149 (NCT NCT01709903)
NCT ID: NCT01709903
Last Updated: 2015-03-17
Results Overview
Measurement of QVA149 110/50 μg o.d. to fluticasone/salmeterol 500/50 μg b.i.d. in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
744 participants
Primary outcome timeframe
26 weeks
Results posted on
2015-03-17
Participant Flow
Patients were randomized into 2 treatment arms of the study with an equal 1:1 randomization ratio: QVA149 and Flut/Salm
A total of 1189 patients were screened; 744 (62.6%) completed the screening phase while 445 (37.4%) patients discontinued prior to completion of the screening phase
Participant milestones
| Measure |
QVA149
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Overall Study
STARTED
|
372
|
372
|
|
Overall Study
COMPLETED
|
343
|
333
|
|
Overall Study
NOT COMPLETED
|
29
|
39
|
Reasons for withdrawal
| Measure |
QVA149
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Overall Study
administrative problems
|
2
|
6
|
|
Overall Study
Abnormal test procedure results
|
1
|
0
|
|
Overall Study
In ability to use device
|
1
|
1
|
|
Overall Study
no longer needed study drug
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Adverse Event
|
11
|
18
|
Baseline Characteristics
A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149
Baseline characteristics by cohort
| Measure |
QVA149
n=372 Participants
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
n=369 Participants
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
Total
n=741 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 7.82 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 7.91 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 7.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
341 Participants
n=5 Participants
|
331 Participants
n=7 Participants
|
672 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
314 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
623 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: FAS
Measurement of QVA149 110/50 μg o.d. to fluticasone/salmeterol 500/50 μg b.i.d. in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD.
Outcome measures
| Measure |
QVA149
n=372 Participants
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
n=369 Participants
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d
|
1.248 liters
Standard Error 0.0173
|
1.176 liters
Standard Error 0.0172
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: FAS
Outcome measures
| Measure |
QVA149
n=372 Participants
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
n=369 Participants
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Superiority of QVA 110/50μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d
|
1.259 liters
Standard Error .0170
|
1.183 liters
Standard Error 0.0168
|
SECONDARY outcome
Timeframe: Day 1, 12 and 26 weeksPopulation: Full Analysis set
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 1 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.
Outcome measures
| Measure |
QVA149
n=372 Participants
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
n=369 Participants
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-4 Hours
12 weeks (n=350,338)
|
1.388 Liter
Standard Deviation 0.0163
|
1.262 Liter
Standard Deviation 0.0161
|
|
Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-4 Hours
Day 1 (n=369,364)
|
1.317 Liter
Standard Deviation 0.0096
|
1.252 Liter
Standard Deviation 0.0094
|
|
Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-4 Hours
26 weeks (n=339,323)
|
1.351 Liter
Standard Deviation 0.0167
|
1.229 Liter
Standard Deviation 0.0167
|
SECONDARY outcome
Timeframe: 6,12,18 and 26 weeksPopulation: Full analysis set
Average of Trough Forced Expiratory Volume in one second (FEV1)
Outcome measures
| Measure |
QVA149
n=372 Participants
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
n=369 Participants
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Analysis of FEV1 (L) Trough Response (Pre-dose) Over the Whole Treatment Period
Week 6 (n=356,341)
|
1.256 liter
Standard Error 0.0151
|
1.184 liter
Standard Error 0.0149
|
|
Analysis of FEV1 (L) Trough Response (Pre-dose) Over the Whole Treatment Period
week 12 (n=346,333)
|
1.265 liter
Standard Error 0.0158
|
1.191 liter
Standard Error 0.0156
|
|
Analysis of FEV1 (L) Trough Response (Pre-dose) Over the Whole Treatment Period
week 18 (n=339,332)
|
1.252 liter
Standard Error 0.0166
|
1.174 liter
Standard Error 0.0164
|
|
Analysis of FEV1 (L) Trough Response (Pre-dose) Over the Whole Treatment Period
week 26 (n=338,324)
|
1.226 liter
Standard Error 0.0171
|
1.142 liter
Standard Error 0.0171
|
SECONDARY outcome
Timeframe: 12 and 26 weeksPopulation: Full Analysis Set
Average of Trough Forced Vital Capacity (FVC) at 23 hours 15 min and the 23 hours 45 min post dose
Outcome measures
| Measure |
QVA149
n=372 Participants
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
n=369 Participants
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Analysis of Trough FVC (L) Over the Whole Treatment Period
week 26 (n= 333,323)
|
2.966 liter
Standard Error 0.0334
|
2.793 liter
Standard Error 0.0333
|
|
Analysis of Trough FVC (L) Over the Whole Treatment Period
Day 1 (n=350,351)
|
3.040 liter
Standard Error 0.0288
|
2.957 liter
Standard Error 0.0280
|
|
Analysis of Trough FVC (L) Over the Whole Treatment Period
Week 12 (n=342,332)
|
3.036 liter
Standard Error 0.0304
|
2.835 liter
Standard Error 0.0302
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis set
A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.
Outcome measures
| Measure |
QVA149
n=372 Participants
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
n=369 Participants
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Health Related Quality of Life Analysis of SGRQ Total Score After 26 Weeks of Treatment
Week 26 (n= 340,329)
|
31.20 numbers on a scale
Standard Error 1.118
|
32.00 numbers on a scale
Standard Error 1.118
|
|
Health Related Quality of Life Analysis of SGRQ Total Score After 26 Weeks of Treatment
Week 26 LOCF(n=354,342)
|
31.74 numbers on a scale
Standard Error 1.136
|
32.43 numbers on a scale
Standard Error 1.130
|
SECONDARY outcome
Timeframe: 12 and 26 weeksPopulation: Full Analysis Set
The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea. ."Baseline 12 weeks" and "Baseline 26 weeks", were the baseline scores for available participants analyzed for each time point.
Outcome measures
| Measure |
QVA149
n=372 Participants
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
n=369 Participants
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Analysis of the TDI Focal Score Over the Whole Treatment Period
26 weeks (n=335,326)
|
3.02 Numbers on a scale
Standard Error 0.266
|
2.86 Numbers on a scale
Standard Error 0.266
|
|
Analysis of the TDI Focal Score Over the Whole Treatment Period
Baseline 12 weeks (n=348,337)
|
6.36 Numbers on a scale
Standard Error 0.096
|
6.36 Numbers on a scale
Standard Error 0.104
|
|
Analysis of the TDI Focal Score Over the Whole Treatment Period
12 weeks (n=348,337)
|
2.62 Numbers on a scale
Standard Error 0.240
|
2.40 Numbers on a scale
Standard Error 0.238
|
|
Analysis of the TDI Focal Score Over the Whole Treatment Period
Baseline 26 weeks (n=335,326)
|
6.38 Numbers on a scale
Standard Error 0.097
|
6.40 Numbers on a scale
Standard Error 0.105
|
SECONDARY outcome
Timeframe: 12 and 26 weeksPopulation: Full Analysis set
The number of puffs of rescue medication taken in the previous 12 hours will be recorded in the Patient Diary in the morning and evening. "Baseline 12 weeks" and "Baseline 26 weeks", were the baseline scores for available participants analyzed for each time point. Less puffs taken is better.
Outcome measures
| Measure |
QVA149
n=372 Participants
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
n=369 Participants
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals
Nighttime 12-16 weeks (n=322,307)
|
0.52 # of puffs
Standard Deviation 1.007
|
0.49 # of puffs
Standard Deviation 0.960
|
|
Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals
Night time 24-26 weeks (n=320,304)
|
0.52 # of puffs
Standard Deviation 1.087
|
0.48 # of puffs
Standard Deviation 0.923
|
|
Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals
Baseline Daytime 12-16 weeks (n=329,318)
|
1.57 # of puffs
Standard Deviation 1.934
|
1.69 # of puffs
Standard Deviation 2.130
|
|
Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals
Daytime 12-16 weeks (n=329,318)
|
0.66 # of puffs
Standard Deviation 1.185
|
0.61 # of puffs
Standard Deviation 1.117
|
|
Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals
Baseline Nighttime 12-16 weeks (n=322,307)
|
1.25 # of puffs
Standard Deviation 1.5954
|
1.24 # of puffs
Standard Deviation 1.707
|
|
Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals
Baseline Daytime 24-26 weeks (n=326,315)
|
1.54 # of puffs
Standard Deviation 1.885
|
1.70 # of puffs
Standard Deviation 2.160
|
|
Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals
Daytime 24-26 weeks (n=326,315)
|
0.63 # of puffs
Standard Deviation 1.226
|
0.62 # of puffs
Standard Deviation 1.135
|
|
Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals
Baseline Night time 24-26 weeks (n=320,304)
|
1.23 # of puffs
Standard Deviation 1.588
|
1.21 # of puffs
Standard Deviation 1.702
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Percentage of nights with 'no nighttime awakenings', percentage of days with 'no daytime symptoms', and percentage of 'days able to perform usual daily activities' over 26 weeks (FAS)
Outcome measures
| Measure |
QVA149
n=372 Participants
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Fluticasone/Salmeterol
n=369 Participants
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Symptoms Reported Using E-diary Over 12 and 26 Weeks of Treatment
% days with 'no daytime symptoms' (n=341,334)
|
7.31 % days in study
Standard Error 1.466
|
10.22 % days in study
Standard Error 1.425
|
|
Symptoms Reported Using E-diary Over 12 and 26 Weeks of Treatment
% nights 'no nighttime awakenings' (n=336,322)
|
67.57 % days in study
Standard Error 2.138
|
67.86 % days in study
Standard Error 2.101
|
|
Symptoms Reported Using E-diary Over 12 and 26 Weeks of Treatment
% days able perform daily activities (n=341,334)
|
44.02 % days in study
Standard Error 2.200
|
42.16 % days in study
Standard Error 2.140
|
Adverse Events
QVA149 110mcg/50mcg
Serious events: 20 serious events
Other events: 107 other events
Deaths: 0 deaths
Salmeterol/Fluticasone 50mcg/500mcg
Serious events: 35 serious events
Other events: 135 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QVA149 110mcg/50mcg
n=372 participants at risk
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Salmeterol/Fluticasone 50mcg/500mcg
n=369 participants at risk
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/372
|
0.27%
1/369
|
|
Cardiac disorders
Acute myocardial infarction
|
0.27%
1/372
|
0.00%
0/369
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/372
|
0.27%
1/369
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/372
|
0.27%
1/369
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/372
|
0.27%
1/369
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/372
|
0.27%
1/369
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/372
|
0.27%
1/369
|
|
Cardiac disorders
Cardiac failure congestive
|
0.27%
1/372
|
0.00%
0/369
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/372
|
0.27%
1/369
|
|
Cardiac disorders
Cor pulmonale
|
0.27%
1/372
|
0.00%
0/369
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.00%
0/372
|
0.27%
1/369
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/372
|
0.27%
1/369
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.27%
1/372
|
0.00%
0/369
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/372
|
0.27%
1/369
|
|
Eye disorders
Pterygium
|
0.27%
1/372
|
0.00%
0/369
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/372
|
0.27%
1/369
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/372
|
0.54%
2/369
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.27%
1/372
|
0.00%
0/369
|
|
General disorders
Hyperplasia
|
0.00%
0/372
|
0.27%
1/369
|
|
General disorders
Sudden cardiac death
|
0.27%
1/372
|
0.00%
0/369
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/372
|
0.27%
1/369
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/372
|
0.27%
1/369
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/372
|
0.27%
1/369
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/372
|
0.54%
2/369
|
|
Infections and infestations
Bronchitis
|
0.00%
0/372
|
0.27%
1/369
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/372
|
0.27%
1/369
|
|
Infections and infestations
Lung infection
|
0.27%
1/372
|
0.54%
2/369
|
|
Infections and infestations
Pneumonia
|
0.54%
2/372
|
1.1%
4/369
|
|
Infections and infestations
Septic shock
|
0.00%
0/372
|
0.54%
2/369
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/372
|
0.27%
1/369
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/372
|
0.27%
1/369
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/372
|
0.27%
1/369
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.27%
1/372
|
0.00%
0/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/372
|
0.27%
1/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.27%
1/372
|
0.00%
0/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/372
|
0.27%
1/369
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.27%
1/372
|
0.00%
0/369
|
|
Nervous system disorders
Cerebral infarction
|
0.54%
2/372
|
0.27%
1/369
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/372
|
0.27%
1/369
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/372
|
0.54%
2/369
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.27%
1/372
|
0.00%
0/369
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
6/372
|
4.6%
17/369
|
|
Respiratory, thoracic and mediastinal disorders
Lung cyst
|
0.00%
0/372
|
0.27%
1/369
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/372
|
0.27%
1/369
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.27%
1/372
|
0.00%
0/369
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/372
|
0.54%
2/369
|
|
Vascular disorders
Aortic aneurysm
|
0.27%
1/372
|
0.00%
0/369
|
|
Vascular disorders
Hypotension
|
0.00%
0/372
|
0.27%
1/369
|
Other adverse events
| Measure |
QVA149 110mcg/50mcg
n=372 participants at risk
QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
|
Salmeterol/Fluticasone 50mcg/500mcg
n=369 participants at risk
Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/372
|
1.1%
4/369
|
|
General disorders
Pyrexia
|
0.81%
3/372
|
1.4%
5/369
|
|
Infections and infestations
Bronchitis
|
1.9%
7/372
|
0.81%
3/369
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
30/372
|
12.2%
45/369
|
|
Infections and infestations
Pneumonia
|
0.27%
1/372
|
1.6%
6/369
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
13/372
|
7.0%
26/369
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
1.3%
5/372
|
0.81%
3/369
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.27%
1/372
|
1.4%
5/369
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
18.5%
69/372
|
22.5%
83/369
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.54%
2/372
|
1.6%
6/369
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.54%
2/372
|
1.6%
6/369
|
|
Vascular disorders
Hypertension
|
0.81%
3/372
|
1.4%
5/369
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
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 (ie, data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER