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Oxygen for Muscles in COPD (OM-COPD)
ISRCTN ISRCTN05334499
DOI 10.1186/ISRCTN05334499
ClinicalTrials.gov identifier NCT01722370
EudraCT number 2011-003595-36
Public title Oxygen for Muscles in COPD (OM-COPD)
Scientific title Can muscle dysfunction in COPD be altered by oxygenation in patients with intermittent hypoxia on exertion?
Acronym OM-COPD
Serial number at source 12180
Study hypothesis 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
Lay summary Not provided at time of registration
Ethics approval 11/WM/0337
Study design Randomised; Interventional; Design type: Treatment
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Chronic obstructive pulmonary disease
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 20/07/2012
Anticipated end date 31/10/2013
Status of trial Completed
Patient information material
Target number of participants UK Sample Size: 25
Interventions 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.
Primary outcome measure(s) Gene expression muscle; Timepoint(s): 0, 3 and 6 months
Secondary outcome measure(s) 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
Sources of funding Linde Healthcare
Trial website
Publications
Contact name Dr  Alice  Wood
  Address Queen Elizabeth Hospital Research Laboratories
Mindelson Way
Edgbaston
  City/town Birmingham
  Zip/Postcode B15 2WB
  Country United Kingdom
  Email a.m.wood@bham.ac.uk
Sponsor University of Birmingham (UK)
  Address Edgbaston
  City/town Birmingham
  Zip/Postcode B15 2TT
  Country United Kingdom
  Sponsor website: http://www.birmingham.ac.uk
Date applied 31/01/2013
Last edited 31/01/2013
Date ISRCTN assigned 31/01/2013
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