Evaluation of an oxygen enhanced magnetic resonance imaging method on patients with chronic obstructive pulmonary disease during 8 weeks treatment with either symbicort Turbuhaler or oxis Turbuhaler
Study identifier:D6256M00046
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An open, randomised, parallel group multi-centre, methodology study, evaluating the Sensitivity of Oxygen-Enhanced Magnetic Resonance Imaging (OE-MRI) in detecting and comparing response to 8 weeks treatment with budesonide/formoterol Turbuhaler® (320/9 µg bid) and formoterol Turbuhaler® (9 µg bid) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
Medical condition
COPD method evaluation
Phase
N/A
Healthy volunteers
No
Study drug
Formoterol Turbuhaler, Budesonide/Formoterol Turbuhaler
Sex
All
Actual Enrollment
59
Study type
Interventional
Age
40 Years - 150 Years
Date
Study Start Date: 01 Aug 2011
Primary Completion Date: 01 Jun 2012
Study Completion Date: 01 Jun 2012
Study design
Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Feb 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 Single Dose evaluation placebo (V5) | Drug: Formoterol Turbuhaler 9 microgram on visit 5 single dose |
| Active Comparator: 2 Single Dose evaluation formoterol (V5) | Drug: Budesonide/Formoterol Turbuhaler 320/9 microgram twice daily during 8 weeks Drug: Formoterol Turbuhaler 9 microgram twice daily during 8 weeks |
