Ambulatory Oxygen Effects on Muscles in COPD (OM-COPD)

University of Birmingham

Status and phase: Completed; Phase 4

Conditions: COPD

Treatments: Drug: Medical air equivalent; Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT01722370

RG-11-132

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of COPD
• desaturation on exertion

Exclusion criteria

• using LTOT
• immobile for other reason than COPD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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25 participants in 2 patient groups, including a placebo group

Medical air equivalent

Placebo Comparator group

Description:

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

Treatment:

Drug: Medical air equivalent

Oxygen

Experimental group

Description:

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

Treatment:

Drug: Oxygen