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Trial Outcomes & Findings for Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35) (NCT NCT01044459)

NCT ID: NCT01044459

Last Updated: 2017-04-20

Results Overview

Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

605 participants

Primary outcome timeframe

From baseline to 52 weeks

Results posted on

2017-04-20

Participant Flow

Patient recruitment occurred from November of 2009 to April of 2010 at 109 study sites (106 sites in the United States and 3 additional sites in Canada). A total of 97 study sites randomized patients (94 in the United States and 3 in Canada).

A 2-week run-in period was used to assess the stability of patients' disease and to establish each patient's baseline characteristics. The run-in period was followed by a 52-week double-blind treatment period.

Participant milestones

Participant milestones
Measure
Aclidinium Bromide 200µg
Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Aclidinium Bromide 400µg
Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Overall Study
STARTED
312
293
Overall Study
COMPLETED
179
162
Overall Study
NOT COMPLETED
133
131

Reasons for withdrawal

Reasons for withdrawal
Measure
Aclidinium Bromide 200µg
Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Aclidinium Bromide 400µg
Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Overall Study
Withdrawal by Subject
21
28
Overall Study
Terminated by Sponsor
22
21
Overall Study
Adverse Event
22
20
Overall Study
Lack of Efficacy
23
12
Overall Study
Protocol Violation
11
16
Overall Study
Other Reason
7
14
Overall Study
COPD exacerbation
9
8
Overall Study
Lost to Follow-up
18
12

Baseline Characteristics

Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Aclidinium Bromide 200µg
n=311 Participants
Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Aclidinium Bromide 400µg
n=291 Participants
Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Total
n=602 Participants
Total of all reporting groups
Age, Continuous
63.0 years
STANDARD_DEVIATION 9.5 • n=99 Participants
64.2 years
STANDARD_DEVIATION 9.9 • n=107 Participants
63.6 years
STANDARD_DEVIATION 9.7 • n=206 Participants
Age, Customized
≥ 40 to < 60 years
113 participants
n=99 Participants
96 participants
n=107 Participants
209 participants
n=206 Participants
Age, Customized
≥ 60 to < 70 years
115 participants
n=99 Participants
99 participants
n=107 Participants
214 participants
n=206 Participants
Age, Customized
≥ 70 years
83 participants
n=99 Participants
96 participants
n=107 Participants
179 participants
n=206 Participants
Sex: Female, Male
Female
127 Participants
n=99 Participants
124 Participants
n=107 Participants
251 Participants
n=206 Participants
Sex: Female, Male
Male
184 Participants
n=99 Participants
167 Participants
n=107 Participants
351 Participants
n=206 Participants
Region of Enrollment
United States
305 participants
n=99 Participants
284 participants
n=107 Participants
589 participants
n=206 Participants
Region of Enrollment
Canada
6 participants
n=99 Participants
7 participants
n=107 Participants
13 participants
n=206 Participants

PRIMARY outcome

Timeframe: From baseline to 52 weeks

Population: Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study.

Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.

Outcome measures

Outcome measures
Measure
Aclidinium Bromide 200µg
n=310 Participants
Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Aclidinium Bromide 400µg
n=290 Participants
Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
0.034 L
Standard Error 0.015
0.072 L
Standard Error 0.015

SECONDARY outcome

Timeframe: 52 weeks

Population: Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study.

Change From Baseline in Peak FEV1 in liters at Week 52.

Outcome measures

Outcome measures
Measure
Aclidinium Bromide 200µg
n=310 Participants
Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Aclidinium Bromide 400µg
n=290 Participants
Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Change From Baseline in Peak FEV1
0.185 L
Standard Error 0.015
0.214 L
Standard Error 0.015

Adverse Events

Aclidinium Bromide 200µg

Serious events: 29 serious events
Other events: 60 other events
Deaths: 0 deaths

Aclidinium Bromide 400µg

Serious events: 29 serious events
Other events: 58 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Aclidinium Bromide 200µg
n=311 participants at risk
Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Aclidinium Bromide 400µg
n=291 participants at risk
Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
1.6%
5/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
2.1%
6/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Cardiac disorders
Acute Myocardial Infarction
0.64%
2/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.69%
2/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Infections and infestations
Pneumonia
0.64%
2/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.69%
2/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.69%
2/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Blood and lymphatic system disorders
Anaemia
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Cardiac disorders
Angina Pectoris
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Psychiatric disorders
Anxiety
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Cardiac disorders
Atrial Fibrillation
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Cardiac disorders
Cadiac Failure Congestive
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Nervous system disorders
Carotid Artery Occlusion
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Hepatobiliary disorders
Cholecystitis Chronic
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Infections and infestations
Clostridial Infection
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Gastrointestinal disorders
Colitis
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Metabolism and nutrition disorders
Dehydration
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Nervous system disorders
Depressed Level of Consciousness
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Psychiatric disorders
Depression
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Injury, poisoning and procedural complications
Fall
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Injury, poisoning and procedural complications
Femur Fracture
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Gastrointestinal disorders
Gastrointestinal Haemorrhage
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Gastrointestinal disorders
Haematochezia
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Infections and infestations
Haemophilus Infection
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Nervous system disorders
Hypoaesthesia
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Gastrointestinal disorders
Intestinal Obstruction
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Infections and infestations
Lobar Pneumonia
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Liver
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to the mediastinum
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Vascular disorders
Peripheral arterial occlusive disease
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer metastatic
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Respiratory, thoracic and mediastinal disorders
Pneumonia pneumococcal
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Renal and urinary disorders
Renal failure
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Renal and urinary disorders
Renal failure acute
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Infections and infestations
Septic shock
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Nervous system disorders
Subarachnoid haemorrhage
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Psychiatric disorders
Suicidal ideation
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Nervous system disorders
Syncope
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Infections and infestations
Tracheobronchitis
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Nervous system disorders
Transient ischaemic attack
0.00%
0/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.34%
1/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Gastrointestinal disorders
Abdominal hernia
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Gastrointestinal disorders
Abdominal pain
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Cardiac disorders
Acute coronary syndrome
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Renal and urinary disorders
Acute prerenal failure
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Cardiac disorders
Aortic valve incompetence
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Hepatobiliary disorders
Bile duct stenosis
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Infections and infestations
Biliary sepsis
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Investigations
Blood glucose increased
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Nervous system disorders
Cerebrovascular accident
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Gastrointestinal disorders
Constipation
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Cardiac disorders
Coronary artery disease
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Psychiatric disorders
Delirium
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Eye disorders
Diplopia
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Infections and infestations
Diverticulitis
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Nervous system disorders
Dizziness
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Psychiatric disorders
Drug dependence
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Investigations
Electrocardiogram T wave inversion
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Musculoskeletal and connective tissue disorders
Flank pain
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Renal and urinary disorders
Haematuria
0.64%
2/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Nervous system disorders
Hemiparesis
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Gastrointestinal disorders
Hiatus hernia
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Gastrointestinal disorders
Intestinal ischaemia
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Cardiac disorders
Left atrial dilatation
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Cardiac disorders
Mitral valve stenosis
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Injury, poisoning and procedural complications
Multiple drug overdose
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Cardiac disorders
Myocardial infarction
0.64%
2/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.64%
2/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Renal and urinary disorders
Renal mass
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Infections and infestations
Sepsis syndrome
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Cardiac disorders
Sick sinus syndrome
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Injury, poisoning and procedural complications
Spinal compression fracture
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Nervous system disorders
Thermohypoaesthesia
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
Ear and labyrinth disorders
Vestibular disorder
0.32%
1/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
0.00%
0/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg

Other adverse events

Other adverse events
Measure
Aclidinium Bromide 200µg
n=311 participants at risk
Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Aclidinium Bromide 400µg
n=291 participants at risk
Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
19.3%
60/311 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg
19.9%
58/291 • Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada).
Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg

Additional Information

AstraZeneca Clinical

Study Information Center

Phone: 1-877-240-9479

Results disclosure agreements

  • Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
  • Publication restrictions are in place

Restriction type: OTHER