At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 137 enrolled
Drug / intervention
budesonide/formoterol Turbuhaler 320/9µg +2 moredrug
Likely dose
budesonide/formoterol Turbuhaler 320/9µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 4 clinical trial evaluating budesonide/formoterol Turbuhaler 320/9µg, formoterol Turbuhaler 9µg, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 137 participants across 9 sites in 2 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesGermany, Switzerland
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2007
Enrollment StartJul 2007
Primary CompletionAug 2008
TodayJul 2026
First PostedJun 21, 2007
Enrollment StartJul 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.0 years ago
Interventions
budesonide/formoterol Turbuhaler 320/9µgdrug
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
formoterol Turbuhaler 9µgdrug
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
Placeboother
Placebo, 1 inhalation twice daily