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Clinical Trials/NCT01722370
NCT01722370
Completed
Phase 4

Can Muscle Dysfunction in COPD be Altered by Oxygenation in Patients With Intermittent Hypoxia on Exertion?

University of Birmingham1 site in 1 country25 target enrollmentAugust 2012

Overview

Phase
Phase 4
Intervention
Medical air equivalent
Conditions
COPD
Sponsor
University of Birmingham
Enrollment
25
Locations
1
Primary Endpoint
Gene expression pattern change between interventions in skeletal muscle biopsy
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels, because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15 hours per day, and has established indications and benefits in COPD. However, the indications for and benefits from ambulatory oxygen supplementation (oxygen just when walking or exercising) are less well understood, in part due to heterogeneity of previous study designs, and lack of long term follow up. This is a pilot study of supplementary ambulatory oxygen in COPD, which allows us to ascertain mechanisms of disease by measuring their degree of systemic inflammation pre and post oxygen supplementation, and measuring changes in gene expression in muscles by means of microarray profiling. Secondly, our study will utilise follow up of clinical parameters including home activity monitoring to ascertain medium/long term benefits of oxygen supplementation in a real life setting. Our hypothesis is that exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alice Turner

Dr

University of Birmingham

Eligibility Criteria

Inclusion Criteria

  • clinical diagnosis of COPD
  • desaturation on exertion

Exclusion Criteria

  • using LTOT
  • immobile for other reason than COPD

Arms & Interventions

Medical air equivalent

Oxygen-nitrogen mix equivalent to medical air when inhaled from a cylinder at 2l/min

Intervention: Medical air equivalent

Oxygen

Ambulatory oxygen delivered at 2l/min on any activity performed by the patient, using a blinded cylinder

Intervention: Oxygen

Outcomes

Primary Outcomes

Gene expression pattern change between interventions in skeletal muscle biopsy

Time Frame: 12 weeks

Secondary Outcomes

  • Six minute walk test distance(12 weeks)
  • Home activity level as measured by Actigraph(6 and 12 weeks)

Study Sites (1)

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