Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
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Brief Summary
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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
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This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.

Official Title
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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).

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Aclidinium bromide
* Drug: Placebo Tiotropium
* Drug: Tiotropium
* Drug: Placebo LAS34273


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tiotropium<br>1 puff, 1 day treatment | Drug: Tiotropium<br>* 1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00<br>|
| Placebo Comparator: Placebo<br>Tiotropium or Aclidinium Placebo, 1 day treatment | Drug: Placebo Tiotropium<br>* 1 puff once daily, 1 day treatment<br>Drug: Placebo LAS34273<br>* 1 puff, 1 dat treatment<br>|
| Experimental: Aclidinium bromide<br>200 micrograms, once daily, 1 day treatment | Drug: Aclidinium bromide<br>* 200 micrograms, once daily, 1 day treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 Percentage Increase | Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD