ACTRN12608000348358
Completed
N/A
The effect of continuous positive airway pressure treatment compared with usual therapy on markers of systemic inflammation, pulmonary function and respiratory-related quality of life in patients with combined chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), a parallel group randomized trial.
HMRC Centre for Clinical Research Excellence in respiratory and sleep0 sites40 target enrollmentJuly 23, 2008
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- HMRC Centre for Clinical Research Excellence in respiratory and sleep
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \>\= 18 years
- •2\. GOLD Stage III or IV (severe COPD): post\-bronchodilator forced expiratory volume in 1 second/forced vital (FEV1/FVC) \< 0\.70, FEV1 \<50% predicted.
- •3\. An established clinical history of COPD
- •4\. Ex\-smokers with a smoking history of at least 10 pack\-years. Ex\-smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1\.
- •5\. Moderate to severe Obstructive Sleep Apnoea (Apnoea Hypopnea Index \>\= 15\)
Exclusion Criteria
- •A subject will not be eligible for inclusion in this study if any of
- •the following criteria apply:
- •\-Subjects who have a moderate exacerbation (that required systemic corticosteroid therapy or antibiotics) of COPD in the previous month or a severe exacerbation (that required hospitalization) in the 3 months prior to baseline visit.
- •\-Current respiratory disorders other than COPD and asthma (e.g., lung cancer, sarcoidosis, tuberculosis, lung fibrosis, bronchiectasis)
- •\-Had lung\-volume reduction surgery and/or a lung transplant
- •\-Requirement for nocturnal non\-invasive ventilation or long term oxygen therapy (defined as oxygen therapy prescribed for 12 hours or more per day) at start of study
- •\-Receiving long\-term oral corticosteroid therapy (defined as continuous use for greater than 6 weeks. Courses of oral corticosteroids separated by a period of less than 7 days will be considered as continuous use).
- •\- Severe OSA (minimum oxygen saturation \< 65% or Respiratory Disturbance Index (RDI) \> 80\) requiring immediate treatment due to severity or increased associated risk (eg Transport worker
- •\-Current treatment with CPAP (defined as CPAP usage within 3 months of baseline visit).
- •\-Unwilling to use CPAP therapy.
Outcomes
Primary Outcomes
Not specified
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