Trial Outcomes & Findings for A Study to Assess the Long-term Safety of QVA149 (NCT NCT01120717)
NCT ID: NCT01120717
Last Updated: 2013-01-31
Results Overview
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
339 participants
Primary outcome timeframe
52 weeks + Follow-up (Up to Day 394)
Results posted on
2013-01-31
Participant Flow
Randomization ratio in the study was 2:1 for QVA149 and Placebo groups. Patients were not stratified by COPD disease severity.
Participant milestones
| Measure |
QVA149
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
|
Placebo
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
113
|
|
Overall Study
Safety Population: Received Study Drug
|
225
|
113
|
|
Overall Study
COMPLETED
|
194
|
89
|
|
Overall Study
NOT COMPLETED
|
32
|
24
|
Reasons for withdrawal
| Measure |
QVA149
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
|
Placebo
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
6
|
|
Overall Study
Adverse Event
|
10
|
6
|
|
Overall Study
Protocol Deviation
|
2
|
5
|
|
Overall Study
Unsatisfactory Therapeutic Effect
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Abnormal Test Procedure Result(s)
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Long-term Safety of QVA149
Baseline characteristics by cohort
| Measure |
QVA149
n=225 Participants
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
|
Placebo
n=113 Participants
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
|
Total
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62.5 years
STANDARD_DEVIATION 8.81 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 8.14 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 8.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
174 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeks + Follow-up (Up to Day 394)Population: Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with safety assessments were included in this analysis.
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.
Outcome measures
| Measure |
QVA149
n=225 Participants
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
|
Placebo
n=113 Participants
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
|
|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events or Death
Adverse events
|
130 participants
|
64 participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events or Death
Serious adverse events
|
37 participants
|
12 participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events or Death
Death - 1st treatment day to 30d after last dose
|
4 participants
|
1 participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events or Death
Death - last dose + 30d until end of follow-up
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full analysis set - all randomized patients who received at least one dose of study drug. Only patients with the required data were included in this analysis.
Pre-dose FEV1 is defined as the average of the FEV1 15 minutes pre-dose and FEV1 45 minutes pre-dose. A mixed model was used with treatment as a fixed effect, average of 15 min and 45 min pre-dose FEV1 at visit 3 as the baseline measurement, and FEV1 prior to inhalation and FEV1 60 min post inhalation of two short acting bronchodialators as covariates. The model also included smoking status at baseline, history of ICS use and country as fixed effects with center nested within country as a random effect.
Outcome measures
| Measure |
QVA149
n=191 Participants
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
|
Placebo
n=88 Participants
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
|
|---|---|---|
|
Pre-dose FEV1
|
1.607 Liter
Standard Error 0.0230
|
1.418 Liter
Standard Error 0.0297
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.
Clinically notable hematology values were: hemoglobin - male \<115g/L, female \<95 g/L; hematocrit - male \<0.37v/v, female \<0.32v/v; white cell count - \<2.8 10E9/L or \>16.0 10E9/L; platelets - \<75 10E9/L or \>700 10E9/L
Outcome measures
| Measure |
QVA149
n=225 Participants
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
|
Placebo
n=113 Participants
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
|
|---|---|---|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hematocrit - male <0.37v/v (n = 164, 77)
|
11 participants
|
3 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hematocrit - female <0.32v/v (n = 49, 25)
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hemoglobin - male <115g/L (n = 164, 77)
|
9 participants
|
1 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Hemoglobin - female <95g/L (n = 50, 25)
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
WBC (total) - <2.8 10E9/L (n = 214, 102)
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
WBC (total) - >16.0 10E9/L (n = 214, 102)
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Platelet count (direct) - <75 10E9/L (n = 214,102)
|
1 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Platelet count (direct) - >700 10E9/L (n=214, 102)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.
Clinically notable biochemistry values were: sodium \<125mmol/L or \>160mmol/L; potassium \<3.0mmol/L or \>6.0mmol/L; BUN \>9.99mmol/L; creatinine \>176.8µmol/L; total protein (serum) \<40g/L or \>95g/L; albumin \<25g/L; bilirubin (total) \>34.2µmol/L; SGPT \>3 x ULN; SGOT \> 3 x ULN; gamma glutamyltransferase \>3 x ULN; alkaline phosphatase (serum) \>3 x ULN; glucose \<2.78mmol/L or \>9.99mmol/L
Outcome measures
| Measure |
QVA149
n=214 Participants
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
|
Placebo
n=101 Participants
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
|
|---|---|---|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
BUN - >9.99mmol/L
|
14 participants
|
4 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Creatinine - >176.8µmol/L
|
1 participants
|
1 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Total protein (serum) - >95g/L
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Albumin - <25g/L
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Sodium - <125mmol/L
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Sodium - >160mmol/L
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Potassium - <3.0mmol/L
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Potassium - >6.0mmol/L
|
2 participants
|
1 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Total protein (serum) - <40g/L
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Bilirubin (total) - >34.2µmol/L (n = 213, 101)
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
SGPT - >3 x ULN
|
2 participants
|
1 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
SGOT - >3 x ULN
|
1 participants
|
2 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Gamma glutamyltransferase - >3 x ULN
|
8 participants
|
7 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Alkaline phosphatase, serum - >3 x ULN
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Glucose - <2.78mmol/L
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Glucose - >9.99mmol/L
|
16 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.
Clinically notable vital sign values were: pulse rate - low, \<40 bpm or \<=50 bpm and decrease from baseline \>=15bpm; pulse rate high, \>130 bpm or \>=120bpm and increase from baseline \>=15 bpm. Systolic blood pressure - low, \<75 mmHg or \<=90 mmHg and decrease from baseline \>=20 mmHg; high, \>200 mmHg or \>=180 mmHg and increase from baseline \>=20 mmHg. Diastolic blood pressure - low, \<40 mmHg or \<=50 mmHg and decrease from baseline \>=15 mmHg; high, \>115 mmHg or \>=105 mmHg and increase from baseline \>=15 mmHg.
Outcome measures
| Measure |
QVA149
n=225 Participants
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
|
Placebo
n=113 Participants
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
|
|---|---|---|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Diastolic blood pressure - high
|
2 participants
|
2 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Pulse rate - low
|
0 participants
|
1 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Pulse rate - high
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Systolic blood pressure - low
|
0 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Systolic blood pressure - high
|
3 participants
|
0 participants
|
|
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Diastolic blood pressure - low
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.
Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).
Outcome measures
| Measure |
QVA149
n=225 Participants
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
|
Placebo
n=113 Participants
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
|
|---|---|---|
|
Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
30 to 60ms change from baseline
|
7 participants
|
5 participants
|
|
Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
> 60ms change from baseline
|
0 participants
|
1 participants
|
Adverse Events
QVA149
Serious events: 37 serious events
Other events: 82 other events
Deaths: 0 deaths
Placebo
Serious events: 12 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QVA149
n=225 participants at risk
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
|
Placebo
n=113 participants at risk
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Cardiac disorders
Cardiac failure congestive
|
0.89%
2/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Cardiac disorders
Coronary artery disease
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Cardiac disorders
Myocardial ischaemia
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Cardiac disorders
Sinus tachycardia
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Ear and labyrinth disorders
Vertigo
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Gastrointestinal disorders
Bezoar
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Immune system disorders
Drug hypersensitivity
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Infections and infestations
Lower respiratory tract infection
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Infections and infestations
Pneumonia
|
3.6%
8/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Infections and infestations
Upper respiratory tract infection
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Infections and infestations
Urinary tract infection
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Injury, poisoning and procedural complications
Contusion
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.89%
2/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Nervous system disorders
Intracranial pressure increased
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Nervous system disorders
Transient ischaemic attack
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Renal and urinary disorders
Urinary retention
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.3%
12/225 • Adverse Events were collected up to Day 394
|
3.5%
4/113 • Adverse Events were collected up to Day 394
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/225 • Adverse Events were collected up to Day 394
|
0.88%
1/113 • Adverse Events were collected up to Day 394
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Vascular disorders
Essential hypertension
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Vascular disorders
Hypertension
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
|
Vascular disorders
Thrombosis
|
0.44%
1/225 • Adverse Events were collected up to Day 394
|
0.00%
0/113 • Adverse Events were collected up to Day 394
|
Other adverse events
| Measure |
QVA149
n=225 participants at risk
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
|
Placebo
n=113 participants at risk
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
|
|---|---|---|
|
Infections and infestations
Lower respiratory tract infection
|
6.2%
14/225 • Adverse Events were collected up to Day 394
|
3.5%
4/113 • Adverse Events were collected up to Day 394
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
11/225 • Adverse Events were collected up to Day 394
|
7.1%
8/113 • Adverse Events were collected up to Day 394
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.0%
18/225 • Adverse Events were collected up to Day 394
|
13.3%
15/113 • Adverse Events were collected up to Day 394
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
24.9%
56/225 • Adverse Events were collected up to Day 394
|
23.9%
27/113 • Adverse Events were collected up to Day 394
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
18/225 • Adverse Events were collected up to Day 394
|
6.2%
7/113 • Adverse Events were collected up to Day 394
|
|
Vascular disorders
Hypertension
|
1.3%
3/225 • Adverse Events were collected up to Day 394
|
5.3%
6/113 • Adverse Events were collected up to Day 394
|
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER