Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
COPD Method Evaluation
Chronic Obstructive Pulmonary Disease Method Evaluation
Eligibility:
All Genders
40+ years
Phase:
EARLY_PHASE1
Brief Summary
The main purpose of this study is to evaluate the sensitivity of a new oxygen enhanced magnetic resonance imaging (OE-MRI) method in detecting changes in the lungs of patients with moderate to severe ...
Eligibility Criteria
Inclusion
- Age greater than or equal to 40 years
- Male and female
- Clinical diagnosis of moderate to severe COPD according GOLD guidelines
- Current or ex smoker with a smoking history equivalent to at least 20 cigarettes smoked per day for 10 years
- A Modified Medical Research Council (MMRC) dyspnoea scale score of ≥2.
- FEV1/FVC \< 0.7 (post-bronchodilator)
- FEV1 \> 40 % PN and \< 70 % PN (post-bronchodilator)
- Clinical Study Protocol Local Amendment affects UK:
- \- FEV1 \> 30 % PN and \< 80 % PN (post-bronchodilator)
Exclusion
- Current diagnosis of asthma according to GINA guidelines
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures as judged by the investigator
- Significant upper or lower respiratory tract infection not fully recovered in the 4 weeks prior to visit 1
- Participation in or scheduled for an intensive COPD rehabilitation program
- Claustrophobia, pacemaker, clips within the brain, previous brain or heart surgery, history of metal in the eye or other MRI contraindication such as obesity or inability to stay in the supine position for 60 minutes
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01257048
Start Date
August 1 2011
End Date
June 1 2012
Last Update
September 3 2012
Active Locations (2)
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1
Research Site
Lund, Sweden
2
Research Site
Manchester, United Kingdom