Evaluation of efficacy on exercise tolerance of Symbicort (budesonide/formoterol) compared to placebo and Oxis in patients with severe COPD - CODEX
Study identifier:D5892C00014
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multi-centre, Randomised, Double-blind, Cross-over Design Study to Evaluate Efficacy on Exercise Tolerance of Symbicort ®(Budesonide/Formoterol) 320/9μg One Inhalation Twice Daily Compared With Placebo and Oxis® 9μg One Inhalation Twice Daily in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD).
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 4
Healthy volunteers
No
Study drug
budesonide/formoterol Turbuhaler 320/9µg, formoterol Turbuhaler 9µg
Sex
All
Actual Enrollment
137
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Jul 2007
Primary Completion Date: 01 Aug 2008
Study Completion Date: 01 Aug 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Symbicort then Formoterol then Placebo Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily | Drug: budesonide/formoterol Turbuhaler 320/9µg Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms Drug: formoterol Turbuhaler 9µg Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily Other: Placebo Placebo, 1 inhalation twice daily |
| Experimental: Formoterol then Symbicort then Placebo Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily | Drug: budesonide/formoterol Turbuhaler 320/9µg Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms Drug: formoterol Turbuhaler 9µg Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily Other: Placebo Placebo, 1 inhalation twice daily |
| Placebo Comparator: Placebo then Formoterol then Symbicort Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | Drug: budesonide/formoterol Turbuhaler 320/9µg Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms Drug: formoterol Turbuhaler 9µg Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily Other: Placebo Placebo, 1 inhalation twice daily |
Contacts
Investigators
Principal Investigator
Tomas Andersson
AstraZeneca
