Last updated: 11/03/2018 15:39:20
31P MRS Ischaemic Exercise Optimisation and COPD
GSK study ID
113784
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 31P MRS Ischaemic Exercise Optimisation and COPD Myopathy Study
Trial description: 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
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
level of skeletal muscle metabolism
Timeframe: 1 year
Secondary outcomes:
determine Markers of disease in patients with COPD-related myopathy
Timeframe: 1 year
Interventions:
Other: MRI scan
Enrollment:
75
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Atrophy, Muscular
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2010 to August 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
Yes
- 1. Fit to safely tolerate procedures
- 2. Male or female between 18 and 80 years of age
- 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
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
London, London, United Kingdom, W12 ONN
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2011-31-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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