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31P MRS Ischaemic Exercise Optimisation and COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01476072
First received: September 29, 2011
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

An MRI study to develop a reliable methodology for 31P MRS ischaemic exercise in order to obtain a consistent standard of measurement of muscle metabolism while maintaining an acceptable level of subject comfort and use optimised method to measure and compare metabolism in the biceps and quadriceps of patients with COPD-related myopathy and control subjects


Condition Intervention Phase
Atrophy, Muscular
Other: MRI scan
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 31P MRS Ischaemic Exercise Optimisation and COPD Myopathy Study

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • level of skeletal muscle metabolism [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    ADP, ATP, PCr, Pi, and pH will be measured during rest, anaerobic exercise and recovery to determine muscle metabolism.


Secondary Outcome Measures:
  • determine Markers of disease in patients with COPD-related myopathy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    tests such as spirometry, muscle biopsy, muscle cross-sectional area CSA, muscle strength to indicate level of disease progression


Enrollment: 75
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no treatment
MRI scans only
Other: MRI scan
MRI scan only, methodology study with no other intervention

Detailed Description:

31P Magnetic Resonance Spectroscopy (31P MRS) is a non-invasive method to measure muscle metabolism during exercise. This protocol is intended to provide information for planning future clinical trials applying 31P MRS as an endpoint measure for proof of pharmacology studies with novel therapeutic molecules. Parts A & B of this study will refine imaging and exercise protocols for 31P MRS during brief periods of muscle ischaemia and will assess the test-retest variance. In Part C we will apply 31P MRS with aerobic exercise in a pilot study to estimate differences in skeletal muscle oxidative metabolism between age- and sex-matched control subjects and patients with myopathy associated with Chronic Obstructive Pulmonary Disease.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Fit to safely tolerate procedures
  2. Male or female between 18 and 80 years of age
  3. If pre-menopausal female, non-pregnant on dipstick urinalysis
  4. Subject and responsible physician agree that the subject will be able to comfortably lie in scanning position in the scanner for up to 90 minutes
  5. Capable of giving written informed consent
  6. All four limbs are intact and free of disease

The following criteria apply to patients with COPD myopathy only:

  1. Established diagnosis of COPD with a disease classification of GOLD Stage II and above with suspected or established diagnosis of myopathy and/or COPD with low BMI (under 20 for men and under 19 for women) and/or MVC under 120% of the BMI.
  2. At least a 20 pack year history of smoking
  3. Resting oxygen saturation above 85% on room air
  4. Ambulant and not oxygen-dependent at rest or during mild exertion

Exclusion Criteria:

  1. Ineligible for MRI/MRS scanning in accordance to local MR safety regulations
  2. Any medical condition, acute or chronic, that will lead to potential discomfort when lying supine in the magnet for periods up to 90 min
  3. Any medical condition that will lead to potential discomfort with repetitive movement of the limb being tested in the scanner
  4. Subjects undergoing ischaemic/anaerobic 31P MRS must have no history of clinically significant peripheral vascular disease, abnormal blood clotting, deep vein thrombosis or pulmonary embolism or suspected clinically significant signs of limb vascular disease on screening examination.
  5. Subjects undergoing ischaemic/anaerobic 31P MRS must not have taken the oral contraceptive pill, hormone replacement therapy, or undergone anaesthesia within past 1 month, or have a history of recent prolonged immobility greater than 4 hours (e.g. air travel), or considered unfit in the opinion of the study physician
  6. Concurrent medical conditions known or suspected that in the opinion of the responsible physician could confound interpretation of results.
  7. A medical or psychiatric history that in the opinion of the responsible physician would risk safety of the subject or well-being of the subject.

The following criteria apply to control subjects and COPD patients participating in Part C of the study:

  1. Oxygen saturations below 85% on room air at rest, or significant desaturation on mild exertion.
  2. Current or recent (<4 weeks) infectious exacerbation of COPD requiring corticosteroid therapy at the time of screening or scanning visit day.
  3. Any significant medical illness other than COPD which, in the opinion of the study physician, may preclude participation or which by virtue of being associated with muscle weakness may cause distortion of the results (e.g. neuromuscular disease, severe heart failure &c).
  4. Control subjects with any history of regular smoking
  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: NCT01476072

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, W12 ONN
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01476072     History of Changes
Other Study ID Numbers: 113784
Study First Received: September 29, 2011
Last Updated: June 27, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Muscular Atrophy
Atrophy
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014