Trial Outcomes & Findings for The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01574651)
NCT ID: NCT01574651
Last Updated: 2014-05-22
Results Overview
SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.
COMPLETED
PHASE3
934 participants
Baseline, week 26
2014-05-22
Participant Flow
Participant milestones
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
Overall Study
STARTED
|
476
|
458
|
|
Overall Study
Full Analysis Set (FAS)
|
476
|
458
|
|
Overall Study
Per Protocol Set (PPS)
|
373
|
374
|
|
Overall Study
COMPLETED
|
415
|
406
|
|
Overall Study
NOT COMPLETED
|
61
|
52
|
Reasons for withdrawal
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Administrative problems
|
0
|
1
|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
Patient's inability to use the device
|
0
|
1
|
|
Overall Study
Adverse Event
|
36
|
27
|
|
Overall Study
Abnormal laboratory value(s)
|
1
|
0
|
|
Overall Study
Abnormal test procedure result(s)
|
1
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
6
|
0
|
|
Overall Study
Protocol Violation
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
9
|
10
|
Baseline Characteristics
The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=476 Participants
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=458 Participants
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
Total
n=934 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 Years
STANDARD_DEVIATION 8.43 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 8.15 • n=7 Participants
|
62.9 Years
STANDARD_DEVIATION 8.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=5 Participants
|
160 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
317 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
615 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 26Population: Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated.
SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.
Outcome measures
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=476 Participants
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=458 Participants
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).
Baseline (n=452,441)
|
44.70 Score on a scale
Standard Deviation 17.718
|
45.68 Score on a scale
Standard Deviation 17.720
|
|
St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).
Week 26 (n=475,456)
|
41.30 Score on a scale
Standard Deviation 19.923
|
43.19 Score on a scale
Standard Deviation 19.284
|
SECONDARY outcome
Timeframe: Baseline, week 26Population: Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated
SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative. Superiority of QVA 110/50 μg to tiotropium 18 μg q.d. plus formoterol 12 μg b.i.d. in terms of health related quality of life as assessed by St George's Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment
Outcome measures
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=476 Participants
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=458 Participants
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).
Baseline (n=452,441)
|
44.70 Score on a scale
Standard Deviation 17.718
|
45.68 Score on a scale
Standard Deviation 17.720
|
|
St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).
Week 26 (n=475,456)
|
41.30 Score on a scale
Standard Deviation 19.923
|
43.19 Score on a scale
Standard Deviation 19.284
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated
Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. missing values were replaced by the latest observed value (LOCF)
Outcome measures
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=462 Participants
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=443 Participants
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.
|
1.34 Units on a scale
Standard Deviation 3.440
|
0.87 Units on a scale
Standard Deviation 3.439
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated
The percent of participants with at least one moderate exacerbation within the 26 weeks that required systemic corticosteroids and/or antibiotics during the treatment
Outcome measures
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=476 Participants
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=458 Participants
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks
|
10.9 Percent of participants
|
13.3 Percent of participants
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated
The percent of patients with at least one severe exacerbation within the 26 weeks that required hospitalization. COPD exacerbations were considered to be severe if hospitalization were required.
Outcome measures
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=476 Participants
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=458 Participants
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
Percent of Participants With at Least One Exacerbation Requiring Hospitalization
|
2.1 Percent of participants
|
2.4 Percent of participants
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated
The number of participants with at least one moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required.
Outcome measures
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=476 Participants
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=458 Participants
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period
|
62 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated
Trough FEV1 is the mean value of FEV1 (forced expiratory volume in one second) measured at 23:15h and 23:45h after the morning doses. The baseline value was measured at day 1 prior to the first dose.
Outcome measures
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=476 Participants
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=458 Participants
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
Trough FEV1 at Baseline and Week 26
Baseline
|
1.329 Liters
Standard Deviation 0.4806
|
1.313 Liters
Standard Deviation 0.4525
|
|
Trough FEV1 at Baseline and Week 26
Week 26
|
1.495 Liters
Standard Deviation 0.5060
|
1.409 Liters
Standard Deviation 0.4878
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated
FEV1 30min is the forced expiratory volume in one second measured 30 min after the morning dose.
Outcome measures
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=476 Participants
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=458 Participants
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
FEV1 30 Min After the Morning Dose at Baseline and Week 26
Baseline (n=475,458)
|
1.517 Liters
Standard Deviation 0.5025
|
1.495 Liters
Standard Deviation 0.4860
|
|
FEV1 30 Min After the Morning Dose at Baseline and Week 26
Week 26 (n=476,458)
|
1.605 Liters
Standard Deviation 0.5356
|
1.565 Liters
Standard Deviation 0.5124
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated
Part I of the SGRQ-C covers "symptoms" and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived "weight". A score was calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status.
Outcome measures
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=476 Participants
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=458 Participants
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C
Week 26 (n=476,458)
|
58.31 Score on a scale
Standard Deviation 21.764
|
60.16 Score on a scale
Standard Deviation 20.678
|
|
Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C
Baseline (n=473,457)
|
64.10 Score on a scale
Standard Deviation 19.884
|
64.29 Score on a scale
Standard Deviation 19.768
|
Adverse Events
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
Tiotropium Plus Formoterol and Placebo to QVA149
Serious adverse events
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=476 participants at risk
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=458 participants at risk
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.21%
1/476
|
0.00%
0/458
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/476
|
0.22%
1/458
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/476
|
0.22%
1/458
|
|
Cardiac disorders
Cardiac failure
|
0.21%
1/476
|
0.00%
0/458
|
|
Cardiac disorders
Cardiac failure chronic
|
0.21%
1/476
|
0.00%
0/458
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.21%
1/476
|
0.00%
0/458
|
|
Cardiac disorders
Cor pulmonale
|
0.21%
1/476
|
0.00%
0/458
|
|
Cardiac disorders
Myocardial infarction
|
0.63%
3/476
|
0.22%
1/458
|
|
Cardiac disorders
Myocarditis
|
0.21%
1/476
|
0.00%
0/458
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/476
|
0.22%
1/458
|
|
Cardiac disorders
Tachycardia
|
0.21%
1/476
|
0.00%
0/458
|
|
Eye disorders
Amblyopia
|
0.21%
1/476
|
0.00%
0/458
|
|
Eye disorders
Cataract cortical
|
0.21%
1/476
|
0.00%
0/458
|
|
Eye disorders
Cataract nuclear
|
0.21%
1/476
|
0.00%
0/458
|
|
Eye disorders
Diplopia
|
0.00%
0/476
|
0.22%
1/458
|
|
Eye disorders
Visual acuity reduced
|
0.21%
1/476
|
0.00%
0/458
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.21%
1/476
|
0.22%
1/458
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/476
|
0.22%
1/458
|
|
General disorders
Cardiac death
|
0.00%
0/476
|
0.22%
1/458
|
|
General disorders
Death
|
0.21%
1/476
|
0.00%
0/458
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/476
|
0.22%
1/458
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/476
|
0.22%
1/458
|
|
Immune system disorders
Drug hypersensitivity
|
0.21%
1/476
|
0.00%
0/458
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/476
|
0.22%
1/458
|
|
Infections and infestations
Pneumonia
|
0.00%
0/476
|
0.87%
4/458
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.21%
1/476
|
0.00%
0/458
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.21%
1/476
|
0.00%
0/458
|
|
Injury, poisoning and procedural complications
Contusion
|
0.21%
1/476
|
0.00%
0/458
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/476
|
0.22%
1/458
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/476
|
0.22%
1/458
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.42%
2/476
|
0.00%
0/458
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.21%
1/476
|
0.00%
0/458
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/476
|
0.22%
1/458
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.21%
1/476
|
0.00%
0/458
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.21%
1/476
|
0.00%
0/458
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.42%
2/476
|
0.00%
0/458
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/476
|
0.22%
1/458
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.21%
1/476
|
0.00%
0/458
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/476
|
0.22%
1/458
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.21%
1/476
|
0.00%
0/458
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.21%
1/476
|
0.00%
0/458
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.21%
1/476
|
0.00%
0/458
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.21%
1/476
|
0.00%
0/458
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage unspecified
|
0.21%
1/476
|
0.00%
0/458
|
|
Nervous system disorders
Brain injury
|
0.00%
0/476
|
0.22%
1/458
|
|
Nervous system disorders
Cerebral ischaemia
|
0.21%
1/476
|
0.00%
0/458
|
|
Nervous system disorders
Cerebrovascular accident
|
0.21%
1/476
|
0.00%
0/458
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/476
|
0.22%
1/458
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/476
|
0.22%
1/458
|
|
Psychiatric disorders
Depression
|
0.00%
0/476
|
0.22%
1/458
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/476
|
0.22%
1/458
|
|
Renal and urinary disorders
Renal failure
|
0.21%
1/476
|
0.00%
0/458
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/476
|
0.66%
3/458
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.21%
1/476
|
0.00%
0/458
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/476
|
0.22%
1/458
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.42%
2/476
|
0.22%
1/458
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.21%
1/476
|
0.00%
0/458
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/476
|
0.22%
1/458
|
|
Surgical and medical procedures
Laryngeal fistula repair
|
0.00%
0/476
|
0.22%
1/458
|
|
Surgical and medical procedures
Mastectomy
|
0.21%
1/476
|
0.00%
0/458
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/476
|
0.22%
1/458
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/476
|
0.22%
1/458
|
Other adverse events
| Measure |
QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol
n=476 participants at risk
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
|
Tiotropium Plus Formoterol and Placebo to QVA149
n=458 participants at risk
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.8%
42/476
|
11.6%
53/458
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
26/476
|
4.4%
20/458
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
9/476
|
3.3%
15/458
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER