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| Name | Class |
|---|---|
| Heart of England NHS Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical air equivalent | Placebo Comparator | Oxygen-nitrogen mix equivalent to medical air when inhaled from a cylinder at 2l/min |
|
| Oxygen | Experimental | Ambulatory oxygen delivered at 2l/min on any activity performed by the patient, using a blinded cylinder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug |
| ||
| Medical air equivalent |
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression pattern change between interventions in skeletal muscle biopsy | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Six minute walk test distance | 12 weeks | |
| Home activity level as measured by Actigraph | 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood gases | 12 weeks | |
| Quality of life | 6 and 12 weeks | |
| Anxiety and depression score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alice M Turner | University of Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart of England NHS Foundation Trust | Birmingham | West Midlands | B9 5SS | United Kingdom |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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|
| 12 weeks |
| Arterial stiffness | 12 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |