Clinical trial NCT01257048: 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: COPD Method Evaluation
Chronic Obstructive Pulmonary Disease Method Evaluation
Keywords: Oxygen enhanced magnetic resonance imaging
chronic obstructive pulmonary disease
method evaluation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Oxygen enhanced MRI V4
timeFrame: Visit 4
measure: Oxygen enhanced MRI V5
timeFrame: Visit 5
measure: Oxygen enhanced MRI V7
timeFrame: Visit 7
Secondary outcomes:
measure: Transferability of OE-MRI technique
timeFrame: 10 months
measure: OE-MRI variables
timeFrame: patients will fill in a patient diary at home between visit 2 and 7
measure: Impulse oscillometry parameters V2
timeFrame: Visit 2
measure: Impulse oscillometry parameters V4
timeFrame: Visit 4
measure: Impulse oscillometry parameters V5
timeFrame: Visit 5
measure: Impulse oscillometry parameters V7
timeFrame: Visit 7
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
References: