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)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT01471171
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Aclidinium bromide Aclidinium Bromide 3-week treatment periods Placebo Placebo 3-week treatment periods
- Primary Outcome Measures
Name Time Method Change From Baseline in Endurance Time (Seconds) Week 3 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Trough Inspiratory Capacity (IC) (Litres) Week 3 Change from baseline in trough IC after 3 weeks of treatment
Change From Baseline in Intensity of Dyspnoea Week 3 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.
Trial Locations
- Locations (10)
Almirall Investigational Site #3
🇩🇪Hannover, Germany
Almirall Investigational Site #8
🇩🇪Hamburg, Germany
Almirall Investigational Site #6
🇩🇪Berlin, Germany
Almirall Investigational Site #10
🇩🇪Berlin, Germany
Almirall Investigational Site #2
🇬🇧London, United Kingdom
Almirall Investigational Site #4
🇪🇸Barcelona, Spain
Almirall Investigational Site #5
🇩🇪Grosshansdorf, Germany
Almirall Investigational Site #9
🇩🇪Hamburg, Germany
Almirall Investigational Site #1
🇪🇸Alicante, Spain
Almirall Investigational Site #7
🇩🇪Lübeck, Germany