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 Overview
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Brief Summary
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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 chronic obstructive pulmonary disease (COPD) following treatment with either Oxis Turbuhaler or Symbicort Turbuhaler.

Official Title
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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)

Conditions
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COPD Method Evaluation, Chronic Obstructive Pulmonary Disease Method Evaluation

Intervention / Treatment
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* Drug: Formoterol Turbuhaler
* Drug: Budesonide/Formoterol Turbuhaler
* Drug: Formoterol Turbuhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Single Dose evaluation placebo (V5) | Drug: Formoterol Turbuhaler<br>* 9 microgram on visit 5 single dose<br>|
| Active Comparator: 2<br>Single Dose evaluation formoterol (V5) | Drug: Budesonide/Formoterol Turbuhaler<br>* 320/9 microgram twice daily during 8 weeks<br>Drug: Formoterol Turbuhaler<br>* 9 microgram twice daily during 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen enhanced MRI V4 | Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters | Visit 4 | 
| Oxygen enhanced MRI V5 | Oxygen enhanced MRI parameters | Visit 5 | 
| Oxygen enhanced MRI V7 | Oxygen enhanced MRI parameters | Visit 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transferability of OE-MRI technique | Transferability of OE-MRI technique to a second centre | 10 months | 
| OE-MRI variables | Relationship with OE-MRI variables and change in lung function | patients will fill in a patient diary at home between visit 2 and 7 | 
| Impulse oscillometry parameters V2 | Impulse oscillometry parameters | Visit 2 | 
| Impulse oscillometry parameters V4 | Impulse oscillometry parameters | Visit 4 | 
| Impulse oscillometry parameters V5 | Impulse oscillometry parameters | Visit 5 | 
| Impulse oscillometry parameters V7 | Impulse oscillometry parameters | Visit 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen enhanced magnetic resonance imaging, chronic obstructive pulmonary disease, method evaluation