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
NCT ID: NCT01257048
Last Updated: 2012-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
34 participants
INTERVENTIONAL
2011-08-31
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Single Dose evaluation placebo (V5)
Formoterol Turbuhaler
9 microgram on visit 5 single dose
2
Single Dose evaluation formoterol (V5)
Budesonide/Formoterol Turbuhaler
320/9 microgram twice daily during 8 weeks
Formoterol Turbuhaler
9 microgram twice daily during 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Formoterol Turbuhaler
9 microgram on visit 5 single dose
Budesonide/Formoterol Turbuhaler
320/9 microgram twice daily during 8 weeks
Formoterol Turbuhaler
9 microgram twice daily during 8 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Lund, , Sweden
Research Site
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-023751
Identifier Type: -
Identifier Source: secondary_id
D6256M00046
Identifier Type: -
Identifier Source: org_study_id