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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01257048
First received: December 3, 2010
Last updated: August 31, 2012
Last verified: August 2012

December 3, 2010
August 31, 2012
August 2011
June 2012   (final data collection date for primary outcome measure)
  • Oxygen enhanced MRI V4 [ Time Frame: Visit 4 ] [ Designated as safety issue: No ]
    Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters
  • Oxygen enhanced MRI V5 [ Time Frame: Visit 5 ] [ Designated as safety issue: No ]
    Oxygen enhanced MRI parameters
  • Oxygen enhanced MRI V7 [ Time Frame: Visit 7 ] [ Designated as safety issue: No ]
    Oxygen enhanced MRI parameters
Same as current
Complete list of historical versions of study NCT01257048 on ClinicalTrials.gov Archive Site
  • Transferability of OE-MRI technique [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Transferability of OE-MRI technique to a second centre
  • OE-MRI variables [ Time Frame: patients will fill in a patient diary at home between visit 2 and 7 ] [ Designated as safety issue: No ]
    Relationship with OE-MRI variables and change in lung function
  • Impulse oscillometry parameters V2 [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
    Impulse oscillometry parameters
  • Impulse oscillometry parameters V4 [ Time Frame: Visit 4 ] [ Designated as safety issue: No ]
    Impulse oscillometry parameters
  • Impulse oscillometry parameters V5 [ Time Frame: Visit 5 ] [ Designated as safety issue: No ]
    Impulse oscillometry parameters
  • Impulse oscillometry parameters V7 [ Time Frame: Visit 7 ] [ Designated as safety issue: No ]
    Impulse oscillometry parameters
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • COPD Method Evaluation
  • Chronic Obstructive Pulmonary Disease Method Evaluation
  • Drug: Formoterol Turbuhaler
    9 microgram on visit 5 single dose
  • Drug: Budesonide/Formoterol Turbuhaler
    320/9 microgram twice daily during 8 weeks
  • Drug: Formoterol Turbuhaler
    9 microgram twice daily during 8 weeks
  • Placebo Comparator: 1
    Single Dose evaluation placebo (V5)
    Intervention: Drug: Formoterol Turbuhaler
  • Active Comparator: 2
    Single Dose evaluation formoterol (V5)
    Interventions:
    • Drug: Budesonide/Formoterol Turbuhaler
    • Drug: Formoterol Turbuhaler
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden,   United Kingdom
 
NCT01257048
D6256M00046, 2010-023751
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP