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

Early Phase 1

Completed

• Conditions: COPD Method Evaluation; Chronic Obstructive Pulmonary Disease Method Evaluation
• Interventions: Drug: Budesonide/Formoterol Turbuhaler; Drug: Formoterol Turbuhaler

• Registration Number: NCT01257048
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Study Start: 2011-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-31
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Formoterol Turbuhaler	Single Dose evaluation formoterol (V5)
1	Formoterol Turbuhaler	Single Dose evaluation placebo (V5)
2	Budesonide/Formoterol Turbuhaler	Single Dose evaluation formoterol (V5)

Primary Outcome Measures

Name	Time	Method
Oxygen enhanced MRI V4	Visit 4	Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters
Oxygen enhanced MRI V5	Visit 5	Oxygen enhanced MRI parameters
Oxygen enhanced MRI V7	Visit 7	Oxygen enhanced MRI parameters

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom