Ambulatory Oxygen Effects on Muscles in COPD

NCT01722370 | Completed Phase 4

• 1 other identifier: RG-11-132
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Gene expression pattern change between interventions in skeletal muscle biopsy

  12 weeks

Secondary Outcomes (2)

• Six minute walk test distance

  12 weeks

• Home activity level as measured by Actigraph

  6 and 12 weeks

Other Outcomes (4)

• Blood gases

  12 weeks

• Quality of life

  6 and 12 weeks

• Anxiety and depression score

  12 weeks

Study Arms (2)

Medical air equivalent

PLACEBO COMPARATOR

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

Drug: Medical air equivalent

Oxygen

EXPERIMENTAL

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

Drug: Oxygen

Interventions

Oxygen DRUG

Oxygen

Medical air equivalent DRUG

Medical air equivalent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of COPD
• desaturation on exertion

You may not qualify if:

• using LTOT
• immobile for other reason than COPD

Sponsors & Collaborators

• University of Birmingham: lead
• Heart of England NHS Trust: collaborator

Study Sites (1)

Heart of England NHS Foundation Trust

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Alice M Turner

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

GB (1)