Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alice Wood

ORCID ID

Contact details

Queen Elizabeth Hospital Research Laboratories
Mindelson Way
Edgbaston
Birmingham
B15 2WB
United Kingdom
a.m.wood@bham.ac.uk

Additional identifiers

EudraCT number

2011-003595-36

ClinicalTrials.gov number

NCT01722370

Protocol/serial number

12180

Study information

Scientific title

Can muscle dysfunction in COPD be altered by oxygenation in patients with intermittent hypoxia on exertion?

Acronym

OM-COPD

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

Ethics approval

11/WM/0337

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Chronic obstructive pulmonary disease

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Gene expression muscle; Timepoint(s): 0, 3 and 6 months

Secondary outcome measures

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

Overall trial start date

20/07/2012

Overall trial end date

31/10/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 25

Participant 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

Recruitment start date

20/07/2012

Recruitment end date

31/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Hospital Research Laboratories
Birmingham
B15 2WB
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

http://www.birmingham.ac.uk

Funders

Funder type

Industry

Funder name

Linde Healthcare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes