Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Randomised, 4-week, Placebo-controlled, Double-blind, 6 Arm Parallel Group, Dose-finding Clinical Trial, to Assess the Efficacy, Safety and Pharmacokinetics of Three Different Doses of Formoterol Combined With the Inhaled Anticholinergic Aclidinium Bromide, Aclidinium Bromide Monotherapy and Formoterol Monotherapy All Administrated Once Daily by Inhalation Via Almirall Inhaler in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease.
NCT number | NCT00626522 |
Other study ID # | CT001148 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | February 21, 2008 |
Last updated | May 28, 2015 |
Start date | January 2008 |
Verified date | May 2015 |
Source | Almirall, S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: National Health and Medical Research Council |
Study type | Interventional |
The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials
Status | Completed |
Enrollment | 513 |
Est. completion date | |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Males and females between 40 and 80 years of age inclusive, - current or ex-smokers of =10 pack-year and with a clinical diagnosis of moderate to severe stable COPD Exclusion Criteria: - History or current diagnosis of asthma - Allergic rhinitis or atopy - Respiratory tract infection or acute COPD exacerbation in the last 6 weeks - Hospitalised for an acute COPD exacerbation in the last 3 months - Contraindication to the use of anticholinergic drugs |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Pr. Philip Thompson | Nedlands |
Lead Sponsor | Collaborator |
---|---|
Almirall, S.A. | Forest Laboratories |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary Function Tests | several | No | |
Secondary | Pharmacokinetics and Safety | several | Yes |
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