Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Multiple Dose, Randomised, Double-blind, Placebo Controlled, 2 Period Crossover Clinical Trial to Assess the Effect of Aclidinium Bromide 400 μg BID on Exercise Endurance in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Verified date | May 2015 |
Source | Almirall, S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 112 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Almirall Investigational Site #10 | Berlin | |
Germany | Almirall Investigational Site #2 | Berlin | |
Germany | Almirall Investigational Site #6 | Berlin | |
Germany | Almirall Investigational Site #4 | Frankfurt | |
Germany | Almirall Investigational Site #5 | Grosshansdorf | |
Germany | Almirall Investigational Site #8 | Hamburg | |
Germany | Almirall Investigational Site #9 | Hamburg | |
Germany | Almirall Investigational Site #3 | Hannover | |
Germany | Almirall Investigational Site #7 | Lübeck | |
Germany | Almirall Investigational Site #1 | Wiesbaden | |
Spain | Almirall Investigational Site #1 | Alicante | |
Spain | Almirall Investigational Site #4 | Barcelona | |
Spain | Almirall Investigational Site #2 | Madrid | |
United Kingdom | Almirall Investigational Site #2 | London |
Lead Sponsor | Collaborator |
---|---|
Almirall, S.A. | Forest Laboratories |
Germany, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Endurance Time (Seconds) | Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment. | Week 3 | No |
Secondary | Change From Baseline in Trough Inspiratory Capacity (IC) (Litres) | Change from baseline in trough IC after 3 weeks of treatment | Week 3 | No |
Secondary | Change From Baseline in Intensity of Dyspnoea | Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment. | Week 3 | No |
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