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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:
ClinicalTrials.gov Identifier:
NCT01257048
First Posted: December 9, 2010
Last Update Posted: September 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition Intervention Phase
COPD Method Evaluation Chronic Obstructive Pulmonary Disease Method Evaluation Drug: Formoterol Turbuhaler Drug: Budesonide/Formoterol Turbuhaler Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Oxygen enhanced MRI V4 [ Time Frame: Visit 4 ]
    Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters

  • Oxygen enhanced MRI V5 [ Time Frame: Visit 5 ]
    Oxygen enhanced MRI parameters

  • Oxygen enhanced MRI V7 [ Time Frame: Visit 7 ]
    Oxygen enhanced MRI parameters


Secondary Outcome Measures:
  • Transferability of OE-MRI technique [ Time Frame: 10 months ]
    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 ]
    Relationship with OE-MRI variables and change in lung function

  • Impulse oscillometry parameters V2 [ Time Frame: Visit 2 ]
    Impulse oscillometry parameters

  • Impulse oscillometry parameters V4 [ Time Frame: Visit 4 ]
    Impulse oscillometry parameters

  • Impulse oscillometry parameters V5 [ Time Frame: Visit 5 ]
    Impulse oscillometry parameters

  • Impulse oscillometry parameters V7 [ Time Frame: Visit 7 ]
    Impulse oscillometry parameters


Enrollment: 34
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Single Dose evaluation placebo (V5)
Drug: Formoterol Turbuhaler
9 microgram on visit 5 single dose
Active Comparator: 2
Single Dose evaluation formoterol (V5)
Drug: Budesonide/Formoterol Turbuhaler
320/9 microgram twice daily during 8 weeks
Drug: Formoterol Turbuhaler
9 microgram twice daily during 8 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257048


Locations
Sweden
Research Site
Lund, Sweden
United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01257048     History of Changes
Other Study ID Numbers: D6256M00046
2010-023751
First Submitted: December 3, 2010
First Posted: December 9, 2010
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by AstraZeneca:
Oxygen enhanced magnetic resonance imaging
chronic obstructive pulmonary disease
method evaluation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists