Ambulatory Oxygen Effects on Muscles in COPD

Phase 4

Completed

• Conditions: COPD
• Interventions: Drug: Medical air equivalent; Drug: Oxygen

• Registration Number: NCT01722370
• Lead Sponsor: University of Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-11-02
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-06
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• clinical diagnosis of COPD
• desaturation on exertion

Exclusion Criteria

• using LTOT
• immobile for other reason than COPD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Medical air equivalent	Medical air equivalent	Oxygen-nitrogen mix equivalent to medical air when inhaled from a cylinder at 2l/min
Oxygen	Oxygen	Ambulatory oxygen delivered at 2l/min on any activity performed by the patient, using a blinded cylinder

Primary Outcome Measures

Name	Time	Method
Gene expression pattern change between interventions in skeletal muscle biopsy	12 weeks

Secondary Outcome Measures

Name	Time	Method
Six minute walk test distance	12 weeks
Home activity level as measured by Actigraph	6 and 12 weeks

Trial Locations

Locations (1)

Heart of England NHS Foundation Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom