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Ambulatory Oxygen Effects on Muscles in COPD

NCT ID: NCT01722370

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Medical air equivalent

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

Group Type PLACEBO_COMPARATOR

Medical air equivalent

Intervention Type DRUG

Oxygen

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

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

Interventions

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Oxygen

Intervention Type DRUG

Medical air equivalent

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of COPD
* desaturation on exertion

Exclusion Criteria

* using LTOT
* immobile for other reason than COPD
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart of England NHS Trust

OTHER

Sponsor Role collaborator

University of Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Alice Turner

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alice M Turner

Role: PRINCIPAL_INVESTIGATOR

University of Birmingham

Locations

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Heart of England NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RG-11-132

Identifier Type: -

Identifier Source: org_study_id