Trial Outcomes & Findings for Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD) (NCT NCT00358436)
NCT ID: NCT00358436
Last Updated: 2017-01-04
Results Overview
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
804 participants
Primary outcome timeframe
28 weeks
Results posted on
2017-01-04
Participant Flow
This study was conducted in a total of 119 enrolling sites: 72 sites in the United States, 13 sites in Argentina, 13 sites in Australia, 7 sites in Canada, 2 sites in Mexico, 3 sites in New Zealand and 9 sites in South Africa. The first patient was screened in August 2006 and the last patient visit was in June 2008.
Following a screening visit, patients entered a 14-day run-in period during which they used inhaled salbutamol on an as needed basis. Patients also stopped taking any other COPD medications prohibited by the study protocol. The 14-day run-in period was used to assess the stability of disease and established the patient's baseline characteristics.
Participant milestones
| Measure |
Aclidinium Bromide 200 μg Once-daily
Aclidinium bromide 200 μg once-daily by inhalation
|
Placebo
Placebo by inhalation
|
|---|---|---|
|
Overall Study
STARTED
|
600
|
204
|
|
Overall Study
COMPLETED
|
446
|
118
|
|
Overall Study
NOT COMPLETED
|
154
|
86
|
Reasons for withdrawal
| Measure |
Aclidinium Bromide 200 μg Once-daily
Aclidinium bromide 200 μg once-daily by inhalation
|
Placebo
Placebo by inhalation
|
|---|---|---|
|
Overall Study
Adverse Event
|
29
|
13
|
|
Overall Study
Lack of Efficacy
|
34
|
36
|
|
Overall Study
Lost to Follow-up
|
11
|
6
|
|
Overall Study
Protocol Violation
|
8
|
3
|
|
Overall Study
Withdrawal by Subject
|
40
|
17
|
|
Overall Study
Non-fulfilment of inclusion/exclusion
|
4
|
0
|
|
Overall Study
COPD exacerbation
|
22
|
10
|
|
Overall Study
Other
|
6
|
1
|
Baseline Characteristics
Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)
Baseline characteristics by cohort
| Measure |
Aclidinium Bromide 200 μg Once-daily
n=600 Participants
Aclidinium bromide 200 μg once-daily by inhalation
|
Placebo
n=204 Participants
Placebo by inhalation
|
Total
n=804 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
292 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
377 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
308 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
427 Participants
n=5 Participants
|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
65.2 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Gender
Female
|
217 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Gender
Male
|
383 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
507 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
122 participants
n=5 Participants
|
42 participants
n=7 Participants
|
164 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
70 participants
n=5 Participants
|
25 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
33 participants
n=5 Participants
|
10 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
12 participants
n=5 Participants
|
4 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
61 participants
n=5 Participants
|
20 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
295 participants
n=5 Participants
|
101 participants
n=7 Participants
|
396 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 weeksPopulation: Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks
Outcome measures
| Measure |
Aclidinium Bromide 200 μg Once-daily
n=594 Participants
Aclidinium bromide 200 μg once-daily by inhalation
|
Placebo
n=201 Participants
Placebo by inhalation
|
|---|---|---|
|
Trough FEV1 (L) at 28 Weeks on Treatment
|
1.220 Liters
Standard Error 0.008
|
1.162 Liters
Standard Error 0.014
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks
Outcome measures
| Measure |
Aclidinium Bromide 200 μg Once-daily
n=594 Participants
Aclidinium bromide 200 μg once-daily by inhalation
|
Placebo
n=201 Participants
Placebo by inhalation
|
|---|---|---|
|
Trough FEV1 (L) at 12 Weeks on Treatment
|
1.233 Liters
Standard Error 0.007
|
1.171 Liters
Standard Error 0.012
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.
Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.
Outcome measures
| Measure |
Aclidinium Bromide 200 μg Once-daily
n=594 Participants
Aclidinium bromide 200 μg once-daily by inhalation
|
Placebo
n=201 Participants
Placebo by inhalation
|
|---|---|---|
|
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
|
NA Days
The median time to first moderate or severe COPD exacerbation could not be estimated for either group since fewer than 50% of the population had experienced a moderate or severe exacerbation.
|
NA Days
The median time to first moderate or severe COPD exacerbation could not be estimated for either group since fewer than 50% of the population had experienced a moderate or severe exacerbation.
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and had at least the baseline and one post-baseline value available for the primary efficacy variable.
Percentage of patients who achieved a clinically relevant improvement in health-related quality of life at 52 weeks, as measured by at least a 4-unit decrease from baseline in St George's Respiratory Questionnaire (SGRQ) total score
Outcome measures
| Measure |
Aclidinium Bromide 200 μg Once-daily
n=574 Participants
Aclidinium bromide 200 μg once-daily by inhalation
|
Placebo
n=195 Participants
Placebo by inhalation
|
|---|---|---|
|
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment
Yes (% Patients with 4-unit decrease)
|
39.0 Percentage of Patients
|
32.8 Percentage of Patients
|
|
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at 52 Weeks on Treatment
No (% Patients without 4-unit decrease)
|
61.0 Percentage of Patients
|
67.2 Percentage of Patients
|
Adverse Events
Aclidinium Bromide 200 μg Once-daily
Serious events: 62 serious events
Other events: 445 other events
Deaths: 0 deaths
Placebo
Serious events: 23 serious events
Other events: 136 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aclidinium Bromide 200 μg Once-daily
n=600 participants at risk
Aclidinium bromide 200 μg once-daily by inhalation
|
Placebo
n=204 participants at risk
Placebo by inhalation
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.33%
2/600 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Acute myocardial infection
|
0.33%
2/600 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Angina pectoris
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.98%
2/204 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Atrial flutter
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.98%
2/204 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.33%
2/600 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
2/600 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Gastrointestinal disorders
Constipation
|
0.33%
2/600 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.33%
2/600 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Infections and infestations
Lobar pneumonia
|
0.50%
3/600 • Number of events 3 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Myocardial infarction
|
0.83%
5/600 • Number of events 5 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.33%
2/600 • Number of events 3 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Infections and infestations
Pneumonia
|
0.83%
5/600 • Number of events 5 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
1.5%
3/204 • Number of events 3 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.98%
2/204 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.33%
2/600 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.98%
2/204 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Nervous system disorders
Syncope
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.98%
2/204 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.33%
2/600 • Number of events 2 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Angina unstable
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Atrial fibrillation
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Atrial thrombosis
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Eye disorders
Retinal detachment
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Gastrointestinal disorders
Diverticulum
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
General disorders
Chest pain
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
General disorders
Condition aggravated
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Immune system disorders
Drug hypersensitivity
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Infections and infestations
Pneumonia Haemophilus
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Infections and infestations
Rickettsiosis
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Infections and infestations
Urosepsis
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Injury, poisoning and procedural complications
Ulnar fracture
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar carcinoma
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointerstinal tract adenoma
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Nervous system disorders
Cerebral infarction
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Nervous system disorders
Convulsion
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Nervous system disorders
Headache
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Nervous system disorders
Myelopathy
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Nervous system disorders
Presycope
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Psychiatric disorders
Anxiety
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Psychiatric disorders
Depression
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Renal and urinary disorders
Scleroderma renal crisis
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Respiratory, thoracic and mediastinal disorders
Bullous lung disease
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Skin and subcutaneous tissue disorders
Angioneurotic oedema
|
0.17%
1/600 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.00%
0/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Vascular disorders
Hypotension
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
0.49%
1/204 • Number of events 1 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
Other adverse events
| Measure |
Aclidinium Bromide 200 μg Once-daily
n=600 participants at risk
Aclidinium bromide 200 μg once-daily by inhalation
|
Placebo
n=204 participants at risk
Placebo by inhalation
|
|---|---|---|
|
Nervous system disorders
Headache
|
14.2%
85/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
12.7%
26/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Infections and infestations
Nasopharyngitis
|
12.7%
76/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
11.3%
23/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.8%
65/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
9.8%
20/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
42/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
3.9%
8/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
40/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
7.4%
15/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
29/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
4.9%
10/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
29/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
3.9%
8/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Vascular disorders
Hypertension
|
4.5%
27/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
2.9%
6/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Infections and infestations
Sinusitis
|
4.5%
27/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
4.4%
9/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.2%
25/600 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
5.4%
11/204 • 52 Weeks
Only COPD exacerbations that were fatal or life-threatening are included here. Other COPD exacerbations were not reported as AEs but were included as part of the efficacy evaluations.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All the information related to this clinical trial is considered strictly confidential and is the property of Almirall. This information will not be given to a third party without the written consent of Almirall. Publication and/or presentation, whether complete or partial, of any part of the data or results of this trial will be subject to revision and written agreement between the investigator and Almirall.
- Publication restrictions are in place
Restriction type: OTHER