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ISRCTN
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ISRCTN05334499
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DOI
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10.1186/ISRCTN05334499
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ClinicalTrials.gov identifier
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NCT01722370
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EudraCT number
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2011-003595-36
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Public title
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Oxygen for Muscles in COPD (OM-COPD)
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Scientific title
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Can muscle dysfunction in COPD be altered by oxygenation in patients with intermittent hypoxia on exertion?
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Acronym
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OM-COPD
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Serial number at source
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12180
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Study hypothesis
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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.
We propose a pilot study of supplementary ambulatory oxygen in COPD, structured in the same manner as one of the larger studies to date in this condition, but with some key differences. Firstly, our study design will allow 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.
More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12180
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Lay summary
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Not provided at time of registration
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Ethics approval
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11/WM/0337
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Study design
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Randomised; Interventional; Design type: Treatment
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Chronic obstructive pulmonary disease
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Participants - inclusion criteria
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1. Spirometry: post bronchodilator [ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs (FEV1/FVC) <0.7]
2. Six-minute walk test (6MWT): desaturation to less than 90% on walking
3. Blood gas: does not meet criteria for LTOT i.e. pO2 >7.3KPa or >8KPa if co-existent cor pulmonale
4. Male & Female; Upper Age Limit 85 years ; Lower Age Limit 25 years
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Participants - exclusion criteria
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1. Imobile due to other medical conditions
2. On LTOT
3. Unable to understand or retain information
4. Uncontrolled anginal symptoms
5. Evidence of potential harm from oxygen supplementation on previous capillary gases or dejours test specifically a rise in CO2 after being given oxygen that is of a clinically significant magnitude
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Anticipated start date
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20/07/2012
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Anticipated end date
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31/10/2013
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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UK Sample Size: 25
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Interventions
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Ambulatory oxygen: Inhaled oxygen given for up to 4 hours/day at 2l/min via cylinder
Placebo, Inhaled gas given at 2l/min, from cylinder for up to 4 hours/day. Is equivalent in oxygen content to medical air.
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Primary outcome measure(s)
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Gene expression muscle; Timepoint(s): 0, 3 and 6 months
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Secondary outcome measure(s)
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1. 6MWT distance; Timepoint(s): 0,3, 6 months
2. Arterial blood gas (ABG); Timepoint(s): 0,3,6 months
3. Home activity level; Timepoint(s): 0, 6, 12, 18, 24 weeks
4. Quality of Life (QOL) - CAT score; Timepoint(s): 0,6,12,18,24,30 weeks
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Sources of funding
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Linde Healthcare
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Trial website
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Publications
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Contact name
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Dr
Alice
Wood
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Address
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Queen Elizabeth Hospital Research Laboratories
Mindelson Way
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2WB
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Country
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United Kingdom
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Email
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a.m.wood@bham.ac.uk
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Sponsor
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University of Birmingham (UK)
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Address
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Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Sponsor website:
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http://www.birmingham.ac.uk
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Date applied
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31/01/2013
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Last edited
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31/01/2013
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Date ISRCTN assigned
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31/01/2013
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