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

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.

Study Overview

• Status: Completed
• Conditions: COPD Method Evaluation; Chronic Obstructive Pulmonary Disease Method Evaluation
• Intervention / Treatment: Drug: Formoterol Turbuhaler; Drug: Formoterol Turbuhaler; Drug: Budesonide/Formoterol Turbuhaler

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Research Site
• United Kingdom
  • Manchester, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: December 3, 2010
• First Submitted That Met QC Criteria: December 8, 2010
• First Posted (Estimate): December 9, 2010

Study Record Updates

• Last Update Posted (Estimate): September 3, 2012
• Last Update Submitted That Met QC Criteria: August 31, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: chronic obstructive pulmonary disease; Oxygen enhanced magnetic resonance imaging; method evaluation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate
• Other Study ID Numbers: D6256M00046; 2010-023751