Evaluate onset of effect in patients with Chronic Obstructive Pulmonary Disease (COPD) treated with formoterol Turbuhaler®
Study identifier:D5127C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomised, placebo-controlled, double-blind (double-dummy technique),crossover, multi-centre study, to evaluate onset of effect in patients with Chronic Obstructive Pulmonary Disease (COPD) treated with formoterol Turbuhaler® 9 μg, compared with Serevent® Diskus® 50 μg.
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
Formoterol, Formoterol, Formoterol, Formoterol, Formoterol, Formoterol, Salmeterol, Salmeterol, Salmeterol, Salmeterol, Salmeterol, Salmeterol, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo
Sex
All
Actual enrollment
109
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Jan 2010
Primary Completion Date: 01 May 2010
Study Completion Date: 01 May 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Formoterol, then Salmeterol, then Placebo Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler | Drug: Formoterol Formoterol Turbuhaler 9 μg and Placebo Diskus Drug: Salmeterol Salmeterol Diskus 50 μg and Placebo Turbuhaler Drug: Placebo Placebo Diskus and Placebo Turbuhaler |
| Experimental: Salmeterol, then Palcebo, then Formoterol Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus | Drug: Formoterol Formoterol Turbuhaler 9 μg and Placebo Diskus Drug: Salmeterol Salmeterol Diskus 50 μg and Placebo Turbuhaler Drug: Placebo Placebo Diskus and Placebo Turbuhaler |
| Experimental: Placebo, then Formoterol, then Salmeterol Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler | Drug: Formoterol Formoterol Turbuhaler 9 μg and Placebo Diskus Drug: Salmeterol Salmeterol Diskus 50 μg and Placebo Turbuhaler Drug: Placebo Placebo Diskus and Placebo Turbuhaler |
| Experimental: Formoterol, then Placebo, then Salmeterol Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler | Drug: Formoterol Formoterol Turbuhaler 9 μg and Placebo Diskus Drug: Salmeterol Salmeterol Diskus 50 μg and Placebo Turbuhaler Drug: Placebo Placebo Diskus and Placebo Turbuhaler |
| Experimental: Salmeterol, then Formoterol, then Placebo Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler | Drug: Formoterol Formoterol Turbuhaler 9 μg and Placebo Diskus Drug: Salmeterol Salmeterol Diskus 50 μg and Placebo Turbuhaler Drug: Placebo Placebo Diskus and Placebo Turbuhaler |
| Experimental: Placebo, then Salmeterol, then Formoterol Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus | Drug: Formoterol Formoterol Turbuhaler 9 μg and Placebo Diskus Drug: Salmeterol Salmeterol Diskus 50 μg and Placebo Turbuhaler Drug: Placebo Placebo Diskus and Placebo Turbuhaler |
Contacts
Investigators
Principal Investigator
Mario Cazzola
Italy
