Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Phase 3
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Registration Number
- NCT00435760
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tiotropium Tiotropium 1 puff, 1 day treatment Placebo Placebo Tiotropium Tiotropium or Aclidinium Placebo, 1 day treatment Placebo Placebo LAS34273 Tiotropium or Aclidinium Placebo, 1 day treatment Aclidinium bromide Aclidinium bromide 200 micrograms, once daily, 1 day treatment
- Primary Outcome Measures
Name Time Method FEV1 Percentage Increase 30 minutes Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes
- Secondary Outcome Measures
Name Time Method Normalised Area FEV1 AUC 0-3h 0-3 hours Normalised area under the curve (AUC) 0-3 hours of FEV1 and change form baseline in FEV1 at 30 min
Trial Locations
- Locations (1)
Respiratory Clinical Trials Ltd
🇬🇧London, United Kingdom