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 - Full Text View

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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) MRI Scans Oxygen Therapy

Drug Information available for: Formoterol fumarate Budesonide Formoterol Arformoterol Tartrate

U.S. FDA Resources

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

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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013