OM-COPD: Ambulatory Oxygen Effects on Muscles in COPD

• Sponsor: University of Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT01722370
• Collaborator: Heart of England NHS Trust (Other)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: Oxygen; Drug: Medical air equivalent	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Can Muscle Dysfunction in COPD be Altered by Oxygenation in Patients With Intermittent Hypoxia on Exertion?
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Gene expression pattern change between interventions in skeletal muscle biopsy [12 weeks]

Secondary Outcome Measures

1. Six minute walk test distance [12 weeks]

2. Home activity level as measured by Actigraph [6 and 12 weeks]

Other Outcome Measures

1. Blood gases [12 weeks]

2. Quality of life [6 and 12 weeks]

3. Anxiety and depression score [12 weeks]

4. Arterial stiffness [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• clinical diagnosis of COPD

• desaturation on exertion

Exclusion Criteria:

• using LTOT

• immobile for other reason than COPD

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart of England NHS Foundation Trust	Birmingham	West Midlands	United Kingdom	B9 5SS

Sponsors and Collaborators

• University of Birmingham
• Heart of England NHS Trust

Investigators

• Principal Investigator: Alice M Turner, University of Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alice Turner, Dr, University of Birmingham
• ClinicalTrials.gov Identifier: NCT01722370
• Other Study ID Numbers: RG-11-132
• First Posted: Nov 6, 2012
• Last Update Posted: Dec 3, 2014
• Last Verified: Dec 1, 2014

Study Results

No Results Posted as of Dec 3, 2014