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)

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257048

Enrollment

Registered

2010-12-09

Start date

2011-08-31

Completion date

2012-06-30

Last updated

2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Method Evaluation, Chronic Obstructive Pulmonary Disease Method Evaluation

Keywords

Oxygen enhanced magnetic resonance imaging, chronic obstructive pulmonary disease, method evaluation

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.

Interventions

DRUGFormoterol Turbuhaler

9 microgram on visit 5 single dose

DRUGBudesonide/Formoterol Turbuhaler

320/9 microgram twice daily during 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Impulse oscillometry parameters V4	Visit 4	Impulse oscillometry parameters
Transferability of OE-MRI technique	10 months	Transferability of OE-MRI technique to a second centre
Impulse oscillometry parameters V7	Visit 7	Impulse oscillometry parameters
Impulse oscillometry parameters V5	Visit 5	Impulse oscillometry parameters
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

Countries

Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026