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, Salmeterol, 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
