Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Single Dose, Double-blind, Double-dummy, 3 Period Cross-over, Placebo Controlled Clinical Trial to Assess the Reate of Onset of Action of Inhaled Aclidinium Bromide 200µg Compared to Placebo and Tiotropium 18µg in Patients With Chronic Obstructive Pulmonary Disease (COPD).
This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.
Status | Completed |
Enrollment | 115 |
Est. completion date | August 2007 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Males and females aged = 40 years - Current or ex-smokers of = 10 pack-year - Clinical diagnosis of 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 - Evidence of contraindicated use of anticholinergic drugs |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Respiratory Clinical Trials Ltd | London |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FEV1 Percentage Increase | Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes | 30 minutes | No |
Secondary | Normalised Area FEV1 AUC 0-3h | Normalised area under the curve (AUC) 0-3 hours of FEV1 and change form baseline in FEV1 at 30 min | 0-3 hours | No |
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