Ambulatory Oxygen Effects on Muscles in COPD

COPD Clinical Trial

— OM-COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722370
• Other study ID #: RG-11-132
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2012
• Last updated: December 1, 2014
• Start date: August 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of COPD

• desaturation on exertion

Exclusion Criteria:

• using LTOT

• immobile for other reason than COPD

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• Oxygen

• Medical air equivalent

Locations

Country	Name	City	State
United Kingdom	Heart of England NHS Foundation Trust	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	Heart of England NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood gases		12 weeks	No
Other	Quality of life		6 and 12 weeks	No
Other	Anxiety and depression score		12 weeks	No
Other	Arterial stiffness		12 weeks	No
Primary	Gene expression pattern change between interventions in skeletal muscle biopsy		12 weeks	No
Secondary	Six minute walk test distance		12 weeks	No
Secondary	Home activity level as measured by Actigraph		6 and 12 weeks	No