The effect of continuous positive airway pressure treatment on markers of systemic inflammation, pulmonary function and respiratory-related quality of life, in patients with combined chronic obstructive pulmonary disease and obstructive sleep apnea, a parallel group randomized trial

Not Applicable

Completed

• Conditions: Chronic obstructive pulmonary disease; Obstructive sleep apnoea; Overlap syndrome; Systemic inflammation; Chronic obstructive pulmonary diseaseObstructive sleep apnoeaOverlap syndrome; Respiratory function; Respiratory - Sleep apnoea

• Registration Number: ACTRN12608000348358
• Lead Sponsor: HMRC Centre for Clinical Research Excellence in respiratory and sleep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.
-Serious, uncontrolled non-respiratory disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the 6-month study duration.
-Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
-Participation in any other interventional research study in the last 4 weeks before baseline visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High sensitivity C-reactive Protein (CRP) measured by blood sampling[Week 0, 6, 12, 24 from baseline visit]