Protocol Summary for 113784
| Protocol Id: | 113784 |
| Secondary Ids: |
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| Title: | 31P MRS Ischaemic Exercise Optimisation and COPD Myopathy Study |
| Phase: | phase 1 |
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| FDA Regulated Intervention?: | No |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Observational |
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| Brief Summary: | 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 |
| 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. |
| Record Verification Date: | September 2011 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | April 2010 |
| Study Completion Date: | August 2011 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | August 2011 |
| Primary Completion Date Type: | Actual |
| Study Design: | Case-Control |
| Time Perspective: | Prospective |
| Biospecimen Retention: | None retained |
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| Study Population: | In part A subjects will be recruited until numbers are sufficient to meet the objectives of Part A, up to a maximum of 25 subjects. Up to 15 subjects will be studied in part B. Up to 25 subjects with COPD and 25 control subjects will be enrolled to allow at least 12 patients and 12 age- and sex- matched controls to be studied in part C. |
| Sampling Method: | Non probability |
| Eligibility Criteria: |
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Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 18 Year |
| Maximum Age: | 80 Year |
| Enrollment: | 75 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | yes |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
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| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: |
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Click to view inclusion/exclusion criteria