Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Placebo

Drug: Aclidinium Bromide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01471171

M/34273/40

Details and patient eligibility

About

The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.

Enrollment

112 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
Post-salbutamol Forced Expiratory Volume in one second(FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) < 70%.
Current or ex-smokers of ≥ 10 pack-years
Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value

Exclusion criteria

History or current diagnosis of asthma
Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Patients with an oxygen saturation < 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
Contra-indications of cardiopulmonary exercise testing.
Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.