formoterol Turbuhaler
Drug9 microgram on visit 5 single dose
NCT Number: NCT01257048
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.
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Notify Me40 year and older
All sexes
Interventional
Early Phase 1
Research Site, Lund, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Clinical Study Protocol Local Amendment affects UK:
Exclusion criteria
9 microgram on visit 5 single dose
320/9 microgram twice daily during 8 weeks
Time frame: Visit 4
Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters
Time frame: Visit 5
Oxygen enhanced MRI parameters
Time frame: Visit 7
Oxygen enhanced MRI parameters
Time frame: 10 months
Transferability of OE-MRI technique to a second centre
Time frame: patients will fill in a patient diary at home between visit 2 and 7
Relationship with OE-MRI variables and change in lung function
Time frame: Visit 2
Impulse oscillometry parameters
Time frame: Visit 4
Impulse oscillometry parameters
Time frame: Visit 5
Impulse oscillometry parameters
Time frame: Visit 7
Impulse oscillometry parameters
AstraZeneca
Industry
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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