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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: Oxygen; Drug: Medical air equivalent

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B9 5SS
      • Heart of England Nhs Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• clinical diagnosis of COPD
• desaturation on exertion

Exclusion Criteria:

• using LTOT
• immobile for other reason than COPD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Medical air equivalent; Oxygen-nitrogen mix equivalent to medical air when inhaled from a cylinder at 2l/min	Drug: Medical air equivalent
Experimental: Oxygen; Ambulatory oxygen delivered at 2l/min on any activity performed by the patient, using a blinded cylinder	Drug: Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gene expression pattern change between interventions in skeletal muscle biopsy	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Six minute walk test distance	12 weeks
Home activity level as measured by Actigraph	6 and 12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Blood gases	12 weeks
Quality of life	6 and 12 weeks
Anxiety and depression score	12 weeks
Arterial stiffness	12 weeks

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: Heart of England NHS Trust
• Investigators: Principal Investigator: Alice M Turner, University of Birmingham

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 2, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: RG-11-132