Back to resultsEvaluation 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
Primary Purpose
COPD Method Evaluation, Chronic Obstructive Pulmonary Disease Method Evaluation
Status
Completed
Phase
Early Phase 1
Locations
International
Study Type
Interventional
Intervention
Formoterol Turbuhaler
Budesonide/Formoterol Turbuhaler
Formoterol Turbuhaler
Sponsored by
About this trial
This is an interventional basic science trial for COPD Method Evaluation focused on measuring Oxygen enhanced magnetic resonance imaging, chronic obstructive pulmonary disease, method evaluation
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
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
1
2
Arm Description
Single Dose evaluation placebo (V5)
Single Dose evaluation formoterol (V5)
Outcomes
Primary Outcome Measures
Oxygen enhanced MRI V4
Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters
Oxygen enhanced MRI V5
Oxygen enhanced MRI parameters
Oxygen enhanced MRI V7
Oxygen enhanced MRI parameters
Secondary Outcome Measures
Transferability of OE-MRI technique
Transferability of OE-MRI technique to a second centre
OE-MRI variables
Relationship with OE-MRI variables and change in lung function
Impulse oscillometry parameters V2
Impulse oscillometry parameters
Impulse oscillometry parameters V4
Impulse oscillometry parameters
Impulse oscillometry parameters V5
Impulse oscillometry parameters
Impulse oscillometry parameters V7
Impulse oscillometry parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01257048
Brief Title
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
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Method Evaluation, Chronic Obstructive Pulmonary Disease Method Evaluation
Keywords
Oxygen enhanced magnetic resonance imaging, chronic obstructive pulmonary disease, method evaluation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Single Dose evaluation placebo (V5)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Single Dose evaluation formoterol (V5)
Intervention Type
Drug
Intervention Name(s)
Formoterol Turbuhaler
Intervention Description
9 microgram on visit 5 single dose
Intervention Type
Drug
Intervention Name(s)
Budesonide/Formoterol Turbuhaler
Intervention Description
320/9 microgram twice daily during 8 weeks
Intervention Type
Drug
Intervention Name(s)
Formoterol Turbuhaler
Intervention Description
9 microgram twice daily during 8 weeks
Primary Outcome Measure Information:
Title
Oxygen enhanced MRI V4
Description
Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters
Time Frame
Visit 4
Title
Oxygen enhanced MRI V5
Description
Oxygen enhanced MRI parameters
Time Frame
Visit 5
Title
Oxygen enhanced MRI V7
Description
Oxygen enhanced MRI parameters
Time Frame
Visit 7
Secondary Outcome Measure Information:
Title
Transferability of OE-MRI technique
Description
Transferability of OE-MRI technique to a second centre
Time Frame
10 months
Title
OE-MRI variables
Description
Relationship with OE-MRI variables and change in lung function
Time Frame
patients will fill in a patient diary at home between visit 2 and 7
Title
Impulse oscillometry parameters V2
Description
Impulse oscillometry parameters
Time Frame
Visit 2
Title
Impulse oscillometry parameters V4
Description
Impulse oscillometry parameters
Time Frame
Visit 4
Title
Impulse oscillometry parameters V5
Description
Impulse oscillometry parameters
Time Frame
Visit 5
Title
Impulse oscillometry parameters V7
Description
Impulse oscillometry parameters
Time Frame
Visit 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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
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