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OpenTrials
Completed

NCT Number: NCT01257048

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

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Site, Lund, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

formoterol Turbuhaler

Drug

9 microgram on visit 5 single dose

budesonide/formoterol Turbuhaler

Drug

320/9 microgram twice daily during 8 weeks

Primary outcomes

  1. Oxygen enhanced MRI V4

    Time frame: Visit 4

    Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters

  2. Oxygen enhanced MRI V5

    Time frame: Visit 5

    Oxygen enhanced MRI parameters

  3. Oxygen enhanced MRI V7

    Time frame: Visit 7

    Oxygen enhanced MRI parameters

Secondary outcomes

  1. Transferability of OE-MRI technique

    Time frame: 10 months

    Transferability of OE-MRI technique to a second centre

  2. 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

  3. Impulse oscillometry parameters V2

    Time frame: Visit 2

    Impulse oscillometry parameters

  4. Impulse oscillometry parameters V4

    Time frame: Visit 4

    Impulse oscillometry parameters

  5. Impulse oscillometry parameters V5

    Time frame: Visit 5

    Impulse oscillometry parameters

  6. Impulse oscillometry parameters V7

    Time frame: Visit 7

    Impulse oscillometry parameters

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 9, 2010
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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