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

AstraZeneca

Status and phase: Completed; Early Phase 1

Conditions: Chronic Obstructive Pulmonary Disease Method Evaluation; COPD Method Evaluation

Treatments: Drug: Formoterol Turbuhaler; Drug: Budesonide/Formoterol Turbuhaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01257048

2010-023751

D6256M00046

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Single Dose evaluation placebo (V5)

Treatment:

Drug: Formoterol Turbuhaler

Drug: Formoterol Turbuhaler

2

Active Comparator group

Description:

Single Dose evaluation formoterol (V5)

Treatment:

Drug: Formoterol Turbuhaler

Drug: Budesonide/Formoterol Turbuhaler

Drug: Formoterol Turbuhaler