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A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

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: NCT01682863
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: QVA149
Drug: QAB149
Drug: Placebo
Enrollment 614
Recruitment Details Patients were randomized to each treatment arm in 1:1:1 ratio.
Pre-assignment Details Six hundred fifteen patients were randomized. One patient was randomized but did not receive treatment due to an adverse event. In the safety set, patients were analyzed according to the treatment received. Therefore, protocol enrollment and analysis set was 614 but the participant flow was 615
Arm/Group Title QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB149 75 ug od
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 204 204 207
Safety Set 204 204 206
Full Analysis Set (FAS) 204 [1] 204 206
Randomized Set 204 204 207 [2]
Completed 177 187 183
Not Completed 27 17 24
Reason Not Completed
Subject/guardian decision             19             12             10
Lost to Follow-up             5             1             6
Death             1             3             4
Protocol deviation             1             0             1
Technical problems             1             0             0
Adverse Event             0             1             2
Physician Decision             0             0             1
[1]
included all randomized patients who received at least one dose of study medication
[2]
1 randomized patient was not treated; experienced an AE prior to receiving any study drug
Arm/Group Title QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB149 75 ug od Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 204 204 207 615
Hide Baseline Analysis Population Description
The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Patients were analyzed according to the treatment they were assigned to at randomization.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 204 participants 204 participants 207 participants 615 participants
64.0  (7.90) 63.9  (8.50) 62.8  (8.52) 63.6  (8.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants 204 participants 207 participants 615 participants
Female
73
  35.8%
81
  39.7%
58
  28.0%
212
  34.5%
Male
131
  64.2%
123
  60.3%
149
  72.0%
403
  65.5%
1.Primary Outcome
Title Number of Patients With Adverse Events, Serious Adverse Events, and Death
Hide Description The overall rate of adverse events reported from initiation through 30 days post last dose.
Time Frame 56 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included.
Arm/Group Title QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB149 75 ug od
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 204 204 206
Measure Type: Number
Unit of Measure: Number of Patients
Patients with at least one SAEs 26 25 24
Patients with at least one AE 139 142 139
Death 1 3 5
2.Secondary Outcome
Title Time to Premature Discontinuation of Treatment
Hide Description methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl
Time Frame 56 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.
Arm/Group Title QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB149 75 ug od
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 204 204 206
Median (95% Confidence Interval)
Unit of Measure: Days
384.0 [1] 
(384.0 to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA- Not estimable
3.Secondary Outcome
Title Change From Baseline in Pre-dose Trough FEV1
Hide Description Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
Time Frame Day 29, 57,, 85, 141, 197, 253, 309 and 365
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.
Arm/Group Title QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB149 75 ug od
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 192 196 199
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Day 29 0.164  (0.0144) 0.194  (0.0143) 0.109  (0.0143)
Day 57 0.178  (0.0151) 0.199  (0.0149) 0.107  (0.0149)
Day 85 0.166  (0.0158) 0.201  (0.0157) 0.095  (0.0157)
Day 141 0.174  (0.0173) 0.198  (0.0170) 0.087  (0.0171)
Day 197 0.138  (0.0167) 0.181  (0.0165) 0.079  (0.0166)
Day 253 0.142  (0.0168) 0.153  (0.0165) 0.074  (0.0167)
Day 309 0.096  (0.0162) 0.123  (0.0161) 0.050  (0.0162)
Day 365 0.116  (0.0169) 0.116  (0.0167) 0.037  (0.0169)
4.Secondary Outcome
Title Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Hide Description Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
Time Frame Day 1, 29, 57, 85, 141, 197, 253, 309, and 365
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.
Arm/Group Title QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB149 75 ug od
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 200 202 202
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Day 1 0.166  (0.0088) 0.178  (0.0088) 0.122  (0.0089)
Day 29 0.257  (0.0152) 0.287  (0.0151) 0.173  (0.0151)
Day 57 0.267  (0.0157) 0.302  (0.0155) 0.173  (0.0154)
Day 85 0.269  (0.0164) 0.301  (0.0162) 0.170  (0.0162)
Day 141 0.268  (0.0182) 0.288  (0.0179) 0.170  (0.0181)
Day 197 0.229  (0.0178) 0.278  (0.0175) 0.157  (0.0177)
Day 253 0.231  (0.0178) 0.240  (0.0175) 0.140  (0.0176)
Day 309 0.199  (0.0170) 0.222  (0.0169) 0.125  (0.0170)
Day 365 0.212  (0.0175) 0.221  (0.0173) 0.104  (0.0174)
5.Secondary Outcome
Title Change From Baseline in FVC Measurement at All Post-baseline Time Points
Hide Description Pulmonary function assessments were performed using centralized spirometry according to international standards.
Time Frame Day1, 29, 57, 85, 141, 197, 253, 309, and 365
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.
Arm/Group Title QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB149 75 ug od
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 200 202 202
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Day 1 0.316  (0.0201) 0.349  (0.0200) 0.248  (0.0203)
Day 29 0.375  (0.0274) 0.440  (0.0271) 0.280  (0.0272)
Day 57 0.390  (0.0274) 0.439  (0.0271) 0.279  (0.0271)
Day 85 0.388  (0.0287) 0.432  (0.0283) 0.268  (0.0284)
Day 141 0.382  (0.0297) 0.403  (0.0292) 0.235  (0.0295)
Day 197 0.313  (0.0288) 0.400  (0.0284) 0.220  (0.0288)
Day 253 0.310  (0.0303) 0.365  (0.0298) 0.205  (0.0301)
Day 309 0.272  (0.0284) 0.334  (0.0281) 0.185  (0.0285)
Day 365 0.312  (0.0286) 0.323  (0.0282) 0.139  (0.0286)
6.Secondary Outcome
Title Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation
Hide Description Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis.
Arm/Group Title QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB149 75 ug od
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 204 204 206
Measure Type: Number
Unit of Measure: Percentage of participants
23.5 24.9 27.0
7.Secondary Outcome
Title Change From Baseline in Mean Total Daily Symptom Scores
Hide Description The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.
Arm/Group Title QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB149 75 ug od
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 198 199 198
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-1.57  (0.133) -1.56  (0.133) -1.31  (0.135)
8.Secondary Outcome
Title Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period
Hide Description Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.
Arm/Group Title QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB149 75 ug od
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 198 199 198
Least Squares Mean (Standard Error)
Unit of Measure: Number of puffs
-1.89  (0.164) -1.62  (0.164) -1.73  (0.166)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB75
Hide Arm/Group Description [Not Specified] [Not Specified] QVA149 27.5/25 μg capsules
All-Cause Mortality
QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB75
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB75
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/204 (12.75%)   25/204 (12.25%)   24/206 (11.65%) 
Blood and lymphatic system disorders       
ANAEMIA  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
Cardiac disorders       
ACUTE MYOCARDIAL INFARCTION  1  2/204 (0.98%)  0/204 (0.00%)  0/206 (0.00%) 
ANGINA UNSTABLE  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
ATRIAL FIBRILLATION  1  1/204 (0.49%)  1/204 (0.49%)  0/206 (0.00%) 
ATRIAL FLUTTER  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
ATRIOVENTRICULAR BLOCK SECOND DEGREE  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
BRADYCARDIA  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
CARDIAC FAILURE  1  0/204 (0.00%)  1/204 (0.49%)  1/206 (0.49%) 
CARDIAC FAILURE ACUTE  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
CARDIAC TAMPONADE  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
CARDIO-RESPIRATORY ARREST  1  0/204 (0.00%)  1/204 (0.49%)  1/206 (0.49%) 
CARDIOGENIC SHOCK  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
CORONARY ARTERY OCCLUSION  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
MYOCARDIAL INFARCTION  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
MYOCARDIAL ISCHAEMIA  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
PERICARDIAL EFFUSION  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
SILENT MYOCARDIAL INFARCTION  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
Congenital, familial and genetic disorders       
ASPLENIA  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
Gastrointestinal disorders       
ABDOMINAL PAIN  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
HIATUS HERNIA  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
INGUINAL HERNIA  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
INGUINAL HERNIA STRANGULATED  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
INTESTINAL OBSTRUCTION  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
LARGE INTESTINE PERFORATION  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
ORAL PAIN  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
General disorders       
FACIAL PAIN  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
NON-CARDIAC CHEST PAIN  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
Infections and infestations       
ARTHRITIS INFECTIVE  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
BRONCHITIS  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
BRONCHOPNEUMONIA  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
DIVERTICULITIS  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
ERYSIPELAS  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
H1N1 INFLUENZA  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  1/204 (0.49%)  1/204 (0.49%)  0/206 (0.00%) 
LUNG INFECTION  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
MENINGITIS  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
PNEUMONIA  1  4/204 (1.96%)  1/204 (0.49%)  2/206 (0.97%) 
PYELONEPHRITIS  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
PYELONEPHRITIS ACUTE  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
SEPSIS  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
SINUSITIS  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION BACTERIAL  1  2/204 (0.98%)  0/204 (0.00%)  0/206 (0.00%) 
URINARY TRACT INFECTION  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
Injury, poisoning and procedural complications       
BRAIN HERNIATION  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
RIB FRACTURE  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
SKULL FRACTURED BASE  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
SUBDURAL HAEMORRHAGE  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
Metabolism and nutrition disorders       
DEHYDRATION  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
HYPERGLYCAEMIA  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
HYPOGLYCAEMIA  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
Musculoskeletal and connective tissue disorders       
INTERVERTEBRAL DISC PROTRUSION  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
ADENOCARCINOMA OF COLON  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
BONE CANCER  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
COLON CANCER  1  1/204 (0.49%)  0/204 (0.00%)  1/206 (0.49%) 
KAPOSI'S SARCOMA  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
LUNG NEOPLASM MALIGNANT  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
METASTASES TO LUNG  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
METASTASES TO PERITONEUM  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
METASTASES TO SPINE  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
NON-SMALL CELL LUNG CANCER STAGE IV  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
PROSTATE CANCER  1  1/204 (0.49%)  0/204 (0.00%)  1/206 (0.49%) 
RENAL CELL CARCINOMA  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
SQUAMOUS CELL CARCINOMA  1  1/204 (0.49%)  1/204 (0.49%)  0/206 (0.00%) 
SQUAMOUS CELL CARCINOMA OF LUNG  1  1/204 (0.49%)  1/204 (0.49%)  0/206 (0.00%) 
Nervous system disorders       
BRAIN OEDEMA  1  0/204 (0.00%)  2/204 (0.98%)  0/206 (0.00%) 
CEREBRAL ISCHAEMIA  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
SUBARACHNOID HAEMORRHAGE  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
TRANSIENT ISCHAEMIC ATTACK  1  1/204 (0.49%)  1/204 (0.49%)  0/206 (0.00%) 
Psychiatric disorders       
PANIC ATTACK  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
SUICIDE ATTEMPT  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
Renal and urinary disorders       
RENAL FAILURE ACUTE  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
RENAL IMPAIRMENT  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
Reproductive system and breast disorders       
BENIGN PROSTATIC HYPERPLASIA  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
Respiratory, thoracic and mediastinal disorders       
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  8/204 (3.92%)  5/204 (2.45%)  10/206 (4.85%) 
HAEMOTHORAX  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
PLEURAL EFFUSION  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
PNEUMONIA ASPIRATION  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
PULMONARY MASS  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
RESPIRATORY FAILURE  1  0/204 (0.00%)  0/204 (0.00%)  1/206 (0.49%) 
Vascular disorders       
AORTIC DISSECTION  1  1/204 (0.49%)  0/204 (0.00%)  1/206 (0.49%) 
HAEMATOMA  1  0/204 (0.00%)  1/204 (0.49%)  0/206 (0.00%) 
HYPOTENSION  1  1/204 (0.49%)  0/204 (0.00%)  0/206 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
QVA149 27.5/12.5 ug Bid QVA149 27.5/25 ug Bid QAB75
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   118/204 (57.84%)   117/204 (57.35%)   112/206 (54.37%) 
Gastrointestinal disorders       
CONSTIPATION  1  1/204 (0.49%)  3/204 (1.47%)  1/206 (0.49%) 
DIARRHOEA  1  5/204 (2.45%)  2/204 (0.98%)  3/206 (1.46%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  4/204 (1.96%)  0/204 (0.00%)  0/206 (0.00%) 
NAUSEA  1  2/204 (0.98%)  4/204 (1.96%)  1/206 (0.49%) 
TOOTHACHE  1  0/204 (0.00%)  5/204 (2.45%)  4/206 (1.94%) 
VOMITING  1  3/204 (1.47%)  2/204 (0.98%)  0/206 (0.00%) 
General disorders       
NON-CARDIAC CHEST PAIN  1  0/204 (0.00%)  4/204 (1.96%)  4/206 (1.94%) 
OEDEMA PERIPHERAL  1  1/204 (0.49%)  6/204 (2.94%)  5/206 (2.43%) 
PYREXIA  1  3/204 (1.47%)  4/204 (1.96%)  0/206 (0.00%) 
Infections and infestations       
BRONCHITIS  1  2/204 (0.98%)  7/204 (3.43%)  8/206 (3.88%) 
INFLUENZA  1  1/204 (0.49%)  2/204 (0.98%)  4/206 (1.94%) 
LOWER RESPIRATORY TRACT INFECTION  1  8/204 (3.92%)  4/204 (1.96%)  6/206 (2.91%) 
NASOPHARYNGITIS  1  19/204 (9.31%)  18/204 (8.82%)  22/206 (10.68%) 
PHARYNGITIS  1  3/204 (1.47%)  0/204 (0.00%)  3/206 (1.46%) 
PNEUMONIA  1  5/204 (2.45%)  3/204 (1.47%)  1/206 (0.49%) 
RESPIRATORY TRACT INFECTION VIRAL  1  3/204 (1.47%)  2/204 (0.98%)  6/206 (2.91%) 
RHINITIS  1  4/204 (1.96%)  3/204 (1.47%)  2/206 (0.97%) 
SINUSITIS  1  5/204 (2.45%)  7/204 (3.43%)  6/206 (2.91%) 
UPPER RESPIRATORY TRACT INFECTION  1  10/204 (4.90%)  10/204 (4.90%)  9/206 (4.37%) 
UPPER RESPIRATORY TRACT INFECTION BACTERIAL  1  10/204 (4.90%)  14/204 (6.86%)  13/206 (6.31%) 
URINARY TRACT INFECTION  1  0/204 (0.00%)  4/204 (1.96%)  3/206 (1.46%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  7/204 (3.43%)  6/204 (2.94%)  7/206 (3.40%) 
Injury, poisoning and procedural complications       
CONTUSION  1  3/204 (1.47%)  2/204 (0.98%)  1/206 (0.49%) 
Metabolism and nutrition disorders       
HYPERGLYCAEMIA  1  3/204 (1.47%)  0/204 (0.00%)  1/206 (0.49%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  2/204 (0.98%)  5/204 (2.45%)  3/206 (1.46%) 
BACK PAIN  1  10/204 (4.90%)  7/204 (3.43%)  5/206 (2.43%) 
MUSCLE SPASMS  1  1/204 (0.49%)  4/204 (1.96%)  1/206 (0.49%) 
MUSCULOSKELETAL PAIN  1  0/204 (0.00%)  3/204 (1.47%)  1/206 (0.49%) 
PAIN IN EXTREMITY  1  3/204 (1.47%)  1/204 (0.49%)  2/206 (0.97%) 
Nervous system disorders       
HEADACHE  1  5/204 (2.45%)  7/204 (3.43%)  4/206 (1.94%) 
Psychiatric disorders       
INSOMNIA  1  3/204 (1.47%)  2/204 (0.98%)  1/206 (0.49%) 
Respiratory, thoracic and mediastinal disorders       
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  70/204 (34.31%)  64/204 (31.37%)  71/206 (34.47%) 
COUGH  1  3/204 (1.47%)  13/204 (6.37%)  7/206 (3.40%) 
DYSPNOEA  1  1/204 (0.49%)  3/204 (1.47%)  6/206 (2.91%) 
NASAL CONGESTION  1  0/204 (0.00%)  1/204 (0.49%)  4/206 (1.94%) 
OROPHARYNGEAL PAIN  1  4/204 (1.96%)  5/204 (2.45%)  3/206 (1.46%) 
PRODUCTIVE COUGH  1  1/204 (0.49%)  3/204 (1.47%)  2/206 (0.97%) 
Skin and subcutaneous tissue disorders       
PRURITUS  1  3/204 (1.47%)  0/204 (0.00%)  0/206 (0.00%) 
SKIN LESION  1  3/204 (1.47%)  0/204 (0.00%)  0/206 (0.00%) 
Vascular disorders       
HYPERTENSION  1  5/204 (2.45%)  10/204 (4.90%)  4/206 (1.94%) 
HYPOTENSION  1  0/204 (0.00%)  3/204 (1.47%)  0/206 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01682863    
Other Study ID Numbers: CQVA149A2340
2012-001998-93
First Submitted: September 7, 2012
First Posted: September 11, 2012
Results First Submitted: June 22, 2015
Results First Posted: March 30, 2016
Last Update Posted: March 30, 2016