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

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ClinicalTrials.gov Identifier: NCT01722370
Recruitment Status : Completed
First Posted : November 6, 2012
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Heart of England NHS Trust
Information provided by (Responsible Party):
Alice Turner, University of Birmingham

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

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Study Type : Interventional  (Clinical Trial)
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 : August 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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



Primary Outcome Measures :
  1. Gene expression pattern change between interventions in skeletal muscle biopsy [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Six minute walk test distance [ Time Frame: 12 weeks ]
  2. Home activity level as measured by Actigraph [ Time Frame: 6 and 12 weeks ]

Other Outcome Measures:
  1. Blood gases [ Time Frame: 12 weeks ]
  2. Quality of life [ Time Frame: 6 and 12 weeks ]
  3. Anxiety and depression score [ Time Frame: 12 weeks ]
  4. Arterial stiffness [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of COPD
  • desaturation on exertion

Exclusion Criteria:

  • using LTOT
  • immobile for other reason than COPD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722370


Locations
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United Kingdom
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
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Principal Investigator: Alice M Turner University of Birmingham
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Responsible Party: Alice Turner, Dr, University of Birmingham
ClinicalTrials.gov Identifier: NCT01722370    
Other Study ID Numbers: RG-11-132
First Posted: November 6, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014