Chronic Obstructive Pulmonary Disease Method Evaluation Clinical Trial
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)
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.
| Status | Completed |
| Enrollment | 34 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Research Site | Lund | |
| United Kingdom | Research Site | Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Oxygen enhanced MRI V4 | Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters | Visit 4 | No |
| Primary | Oxygen enhanced MRI V5 | Oxygen enhanced MRI parameters | Visit 5 | No |
| Primary | Oxygen enhanced MRI V7 | Oxygen enhanced MRI parameters | Visit 7 | No |
| Secondary | Transferability of OE-MRI technique | Transferability of OE-MRI technique to a second centre | 10 months | No |
| Secondary | 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 | No |
| Secondary | Impulse oscillometry parameters V2 | Impulse oscillometry parameters | Visit 2 | No |
| Secondary | Impulse oscillometry parameters V4 | Impulse oscillometry parameters | Visit 4 | No |
| Secondary | Impulse oscillometry parameters V5 | Impulse oscillometry parameters | Visit 5 | No |
| Secondary | Impulse oscillometry parameters V7 | Impulse oscillometry parameters | Visit 7 | No |