Last reviewed · How we verify
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). (CODEX)
The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 137 |
| Start date | 2007-07 |
| Completion | 2008-08 |
Conditions
- Chronic Obstructive Pulmonary Disease
Interventions
- budesonide/formoterol Turbuhaler 320/9µg
- formoterol Turbuhaler 9µg
- Placebo
Primary outcomes
- Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose — Single measurement taken1 hour post-dose at the end of each 1-week treatment period
Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.
Countries
Germany, Switzerland