Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Registration Number
- NCT01462929
- Lead Sponsor
- AstraZeneca
- Brief Summary
The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 414
- Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
- Post-salbutamol (FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
- Current or ex-smokers of 10 ≥pack-years.
- Patients with no history or current diagnosis of asthma.
- No evidence of an exacerbation within 6 weeks prior to the screening visit.
- No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
- No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aclidinium bromide Aclidinium bromide Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment Placebo Placebo Placebo comparator administered during 6 weeks of treatment Tiotropium Tiotropium Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment
- Primary Outcome Measures
Name Time Method Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment Week 6 Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment Week 6 Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.
Trial Locations
- Locations (22)
Almirall Investigational Site #14
🇵🇱Tarnow, Poland
Almirall Investigational Site #17
🇵🇱Krakow, Poland
Almirall Investigational Site #9
🇩🇪Frankfurt, Germany
Almirall Investigational Site #4
🇵🇱Proszowice, Poland
Almirall Investigational Site #16
🇵🇱Lodz, Poland
Almirall Investigational Site #1
🇭🇺Szarvas, Hungary
Almirall Investigational Site #24
🇩🇪Koln, Germany
Almirall Investigational Site #21
🇩🇪Berlin, Germany
Almirall Investigational Site #6
🇵🇱Sopot, Poland
Almirall Investigational Site #19
🇵🇱Warszawa, Poland
Almirall Investigational Site #8
🇵🇱Bialystok, Poland
Almirall Investigational Site #13
🇵🇱Wroclaw, Poland
Almirall Investigational Site #20
🇵🇱Lodz, Poland
Almirall Investigational Site #2
🇵🇱Elblag, Poland
Almirall Investigational Site #23
🇩🇪Rudersdorf, Germany
Almirall Investigational Site #22
🇩🇪Hannover, Germany
Almirall Investigational Site #11
🇭🇺Szigetszentmiklos, Hungary
Almirall Investigational Site #12
🇵🇱Wilkowice-Bystra, Poland
Almirall Investigational Site #10
🇵🇱Krakow, Poland
Almirall Investigational Site #3
🇭🇺Matrahaza, Hungary
Almirall Investigational Site #18
🇵🇱Bialystok, Poland
Almirall Investigational Site #5
🇩🇪Hannover, Germany