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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
Location
Research Site
BERLIN, Germany
Location
Research Site
ERFURT, Germany
Location
Research Site
FULDA, Germany
Location
Research Site
FURTH, Germany
Location
Research Site
GEESTHACHT, Germany
Location
Research Site
GROBHANSDORF, Germany
Location
Research Site
LEIPZIG, Germany
Location
Research Site
NEURUPPIN, Germany
| 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
