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
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257048

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01257048     History of Changes
Other Study ID Numbers: D6256M00046, 2010-023751
Study First Received: December 3, 2010
Last Updated: August 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency

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
Budesonide
Formoterol
Symbicort
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014