Trial Outcomes & Findings for A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00363896)

NCT ID: NCT00363896

Last Updated: 2017-01-06

Results Overview

Trough FEV1 (mean of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 843 participants
• Primary outcome timeframe: Week 28
• Results posted on: 2017-01-06

Participant Flow

The study was conducted in 132 sites: 1 in Andorra, 5 in Austria, 4 in Belgium, 10 in Bulgaria, 8 in the Czech Republic, 3 in Denmark, 9 in France, 10 in Germany, 8 in Hungary, 6 in Italy, 4 in Netherlands, 9 in Poland, 9 in Romania, 25 in Russia, 8 in Spain, 13 in the UK. First patient was screened in Aug 2006 and last patient visit was May 2008.

Following a screening visit, patients entered a 14-day run-in period during which they used inhaled salbutamol administered via a pressurised metered dose inhaler (pMDI) as rescue medication on an "as needed" basis. The 14-day run-in period was used to assess the stability of each patient's disease and 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	627	216
Overall Study COMPLETED	538	169
Overall Study NOT COMPLETED	89	47

Reasons for withdrawal

Measure	Aclidinium Bromide 200 μg Once-daily Aclidinium bromide 200 μg once-daily by inhalation	Placebo Placebo by inhalation
Overall Study Withdrawal by Subject	29	16
Overall Study Adverse Event	24	13
Overall Study COPD exacerbation	13	7
Overall Study Lack of Efficacy	12	8
Overall Study Protocol Violation	6	1
Overall Study Lost to Follow-up	3	0
Overall Study Non-fulfilment of entry criteria	1	0
Overall Study Other	1	2

Baseline Characteristics

A Trial Assessing LAS34273 in Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Measure	Aclidinium Bromide 200 μg Once-daily n=627 Participants Aclidinium bromide 200 μg once-daily by inhalation	Placebo n=216 Participants Placebo by inhalation	Total n=843 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	378 Participants n=5 Participants	134 Participants n=7 Participants	512 Participants n=5 Participants
Age, Categorical >=65 years	249 Participants n=5 Participants	82 Participants n=7 Participants	331 Participants n=5 Participants
Age, Continuous	62.6 years STANDARD_DEVIATION 8.2 • n=5 Participants	61.9 years STANDARD_DEVIATION 8.3 • n=7 Participants	62.4 years STANDARD_DEVIATION 8.2 • n=5 Participants
Gender Female	139 Participants n=5 Participants	41 Participants n=7 Participants	180 Participants n=5 Participants
Gender Male	488 Participants n=5 Participants	175 Participants n=7 Participants	663 Participants n=5 Participants
Region of Enrollment Andorra	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Austria	14 participants n=5 Participants	4 participants n=7 Participants	18 participants n=5 Participants
Region of Enrollment Belgium	9 participants n=5 Participants	2 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Bulgaria	61 participants n=5 Participants	20 participants n=7 Participants	81 participants n=5 Participants
Region of Enrollment Czech Republic	43 participants n=5 Participants	15 participants n=7 Participants	58 participants n=5 Participants
Region of Enrollment Germany	56 participants n=5 Participants	18 participants n=7 Participants	74 participants n=5 Participants
Region of Enrollment Denmark	9 participants n=5 Participants	3 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Spain	31 participants n=5 Participants	10 participants n=7 Participants	41 participants n=5 Participants
Region of Enrollment France	36 participants n=5 Participants	14 participants n=7 Participants	50 participants n=5 Participants
Region of Enrollment United Kingdom	46 participants n=5 Participants	13 participants n=7 Participants	59 participants n=5 Participants
Region of Enrollment Hungary	39 participants n=5 Participants	15 participants n=7 Participants	54 participants n=5 Participants
Region of Enrollment Italy	12 participants n=5 Participants	5 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Netherlands	17 participants n=5 Participants	6 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment Poland	64 participants n=5 Participants	22 participants n=7 Participants	86 participants n=5 Participants
Region of Enrollment Romania	37 participants n=5 Participants	13 participants n=7 Participants	50 participants n=5 Participants
Region of Enrollment Russian Federation	150 participants n=5 Participants	55 participants n=7 Participants	205 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 28

Population: 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 of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 28 weeks

Outcome measures

Measure	Aclidinium 200 μg Once-daily n=616 Participants Aclidinium bromide 200 μg once-daily via inhalation	Placebo n=210 Participants Placebo once-daily via inhalation
Trough FEV1 (L) at 28 Weeks on Treatment	1.422 Liters Standard Error 0.011	1.356 Liters Standard Error 0.017

PRIMARY outcome

Timeframe: Week 12

Population: 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 of two highest FEV1 values assessed at 23 and 24 hours after inhalation) at 12 weeks

Outcome measures

Measure	Aclidinium 200 μg Once-daily n=616 Participants Aclidinium bromide 200 μg once-daily via inhalation	Placebo n=210 Participants Placebo once-daily via inhalation
Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment	1.428 Liters Standard Error 0.010	1.366 Liters Standard Error 0.016

SECONDARY outcome

Timeframe: Week 52

Population: 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 200 μg Once-daily n=616 Participants Aclidinium bromide 200 μg once-daily via inhalation	Placebo n=210 Participants Placebo once-daily via 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 weeks

Population: 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 200 μg Once-daily n=591 Participants Aclidinium bromide 200 μg once-daily via inhalation	Placebo n=200 Participants Placebo once-daily via 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)	48.1 Percentage of Patients	39.5 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)	52.0 Percentage of Patients	60.5 Percentage of Patients

Adverse Events

Aclidinium Bromide 200 μg Once-daily

Serious events: 50 serious events

Other events: 232 other events

Deaths: 0 deaths

Placebo

Serious events: 22 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aclidinium Bromide 200 μg Once-daily n=627 participants at risk Aclidinium bromide 200 μg once-daily by inhalation	Placebo n=216 participants at risk Placebo by inhalation
Cardiac disorders Acute myocardial infarction	0.16% 1/627 • 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% 0/216 • 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	0.32% 2/627 • 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% 0/216 • 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	0.16% 1/627 • 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.	0.46% 1/216 • 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 Atrioventricular block	0.16% 1/627 • 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% 0/216 • 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 arrest	0.00% 0/627 • 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.	0.46% 1/216 • 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	0.16% 1/627 • 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% 0/216 • 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 fibrillation	0.16% 1/627 • 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% 0/216 • 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 Cardiopulmonary failure	0.00% 0/627 • 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.	0.46% 1/216 • 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 Extrasystoles	0.16% 1/627 • 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% 0/216 • 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 Mitrial valve incompetence	0.16% 1/627 • 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% 0/216 • 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	0.00% 0/627 • 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.	0.46% 1/216 • 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 Supraventricular extrasystoles	0.00% 0/627 • 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.	0.46% 1/216 • 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.
Eye disorders Angle closure glaucoma	0.16% 1/627 • 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% 0/216 • 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 Cataract cortical	0.16% 1/627 • 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% 0/216 • 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 Open angle glaucoma	0.16% 1/627 • 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% 0/216 • 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	0.16% 1/627 • 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% 0/216 • 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 pain	0.00% 0/627 • 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.	0.46% 1/216 • 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 Acute abdomen	0.16% 1/627 • 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% 0/216 • 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	0.16% 1/627 • 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% 0/216 • 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 Diverticular perforation	0.00% 0/627 • 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.	0.46% 1/216 • 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	0.16% 1/627 • 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.	0.46% 1/216 • 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 Intestinal ischaemia	0.16% 1/627 • 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% 0/216 • 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 acute	0.16% 1/627 • 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% 0/216 • 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 Peritonitis	0.00% 0/627 • 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.	0.46% 1/216 • 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	0.16% 1/627 • 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% 0/216 • 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 Sudden cardiac death	0.32% 2/627 • 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% 0/216 • 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 Bronchopneumonia	0.00% 0/627 • 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.	0.46% 1/216 • 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 Hepatitis C	0.00% 0/627 • 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.	0.46% 1/216 • 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 Lobar pneumonia	0.16% 1/627 • 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.	0.46% 1/216 • 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 Oesophageal candidiasis	0.00% 0/627 • 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.	0.46% 1/216 • 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	1.3% 8/627 • Number of events 9 • 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.	1.4% 3/216 • 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.
Infections and infestations Sepsis	0.16% 1/627 • 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% 0/216 • 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 Septic shock	0.00% 0/627 • 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.	0.46% 1/216 • 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 Brain contusion	0.00% 0/627 • 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.	0.46% 1/216 • 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 Femur fracture	0.16% 1/627 • 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% 0/216 • 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 Foot fracture	0.16% 1/627 • 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% 0/216 • 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 Injury	0.00% 0/627 • 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.	0.46% 1/216 • 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 Pneumothorax traumatic	0.00% 0/627 • 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.	0.46% 1/216 • 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 Rib fracture	0.00% 0/627 • 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.	0.93% 2/216 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/627 • 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.	0.46% 1/216 • 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) Bladder cancer	0.16% 1/627 • 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% 0/216 • 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 cancer recurrent	0.16% 1/627 • 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% 0/216 • 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) Bronchial carcinoma	0.16% 1/627 • 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% 0/216 • 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	0.00% 0/627 • 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.	0.46% 1/216 • 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	0.16% 1/627 • 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% 0/216 • 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	0.00% 0/627 • 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.	0.46% 1/216 • 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 neoplasm malignant	0.16% 1/627 • 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% 0/216 • 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) Malignant pleural effusion	0.00% 0/627 • 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.	0.46% 1/216 • 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) Meningioma	0.16% 1/627 • 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% 0/216 • 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 lung	0.00% 0/627 • 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.	0.46% 1/216 • 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 bronchial carcinoma	0.16% 1/627 • 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% 0/216 • 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 malignant melanoma	0.16% 1/627 • 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% 0/216 • 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) Pancreatic carcinoma	0.16% 1/627 • 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% 0/216 • 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 neoplasm	0.16% 1/627 • 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% 0/216 • 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) Tongue neoplasm malignant stage unspecified	0.16% 1/627 • 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% 0/216 • 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	0.16% 1/627 • 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% 0/216 • 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	0.00% 0/627 • 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.	0.46% 1/216 • 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 Dizziness	0.16% 1/627 • 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% 0/216 • 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 Ischaemic stroke	0.16% 1/627 • 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% 0/216 • 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 Sciatica	0.16% 1/627 • 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% 0/216 • 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 Trigeminal neuralgia	0.00% 0/627 • 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.	0.46% 1/216 • 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.
Psychiatric disorders Depression suicidal	0.16% 1/627 • 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% 0/216 • 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	0.16% 1/627 • 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% 0/216 • 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.
Pregnancy, puerperium and perinatal conditions Phimosis	0.16% 1/627 • 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% 0/216 • 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	0.16% 1/627 • 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% 0/216 • 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 Chronic obstructive pulmonary disease	0.32% 2/627 • 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.	0.93% 2/216 • 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 Epistaxis	0.32% 2/627 • 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% 0/216 • 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 Pneumothorax	0.16% 1/627 • 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% 0/216 • 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	0.32% 2/627 • 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% 0/216 • 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 oedema	0.16% 1/627 • 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.	0.46% 1/216 • 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 Respiratory failure	0.00% 0/627 • 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.	1.4% 3/216 • 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.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.16% 1/627 • 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% 0/216 • 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 Cardiovascular insufficiency	0.16% 1/627 • 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% 0/216 • 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 Deep vein thrombosis	0.16% 1/627 • 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% 0/216 • 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 Femoral artery occlusion	0.16% 1/627 • 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% 0/216 • 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 Hypertensive crisis	0.16% 1/627 • 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% 0/216 • 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 Iliac artery emolism	0.16% 1/627 • 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% 0/216 • 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 Iliac artery thrombosis	0.16% 1/627 • 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% 0/216 • 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 ischaemia	0.16% 1/627 • 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% 0/216 • 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=627 participants at risk Aclidinium bromide 200 μg once-daily by inhalation	Placebo n=216 participants at risk Placebo by inhalation
Infections and infestations Nasopharyngitis	16.3% 102/627 • 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.	14.4% 31/216 • 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	11.3% 71/627 • 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.	12.5% 27/216 • 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	4.8% 30/627 • 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.	4.6% 10/216 • 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	4.6% 29/627 • 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.	3.7% 8/216 • 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

AstraZeneca Clinical

Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

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