None listed
Conditions
Brief summary
In this study, we aim to improve the evidence-based management of moderate to severe COPD patients with concurrent obstructive sleep apnea. Our primary hypothesis: Treatment of moderate to severe OSA with CPAP in patients with GOLD Stage III COPD leads to reduced systemic inflammation. Our secondary hypotheses: 1. This reduction in inflammation is associated with an improvement in respiratory outcomes (Quality of life, symptoms) in COPD. 2. CPAP therapy is well-tolerated in COPD patients with significant OSA.
Interventions
This is a randomised, parallel-group, controlled trial of the addition of 6 months continuous positive airway pressure (CPAP) therapy, in addition to usual medical care for COPD.
Primary hypothesis:
Treatment of moderate to severe OSA with CPAP in patients with Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (GOLD) Stage III or IV COPD leads to reduced systemic inflammation.
Secondary hypotheses:
This reduction in inflammation is assoc
This is a randomised, parallel-group, controlled trial of the addition of 6 months continuous positive airway pressure (CPAP) therapy, in addition to usual medical care for COPD. Primary hypothesis: Treatment of moderate to severe OSA with CPAP in patients with Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (GOLD) Stage III or IV COPD leads to reduced systemic inflammation. Secondary hypotheses: This reduction in inflammation is associated with an improvement in respiratory outcomes (Quality of life, symptoms) in COPD. CPAP therapy is well-tolerated in COPD patients with significant OSA. CPAP therapy is used each night during sleep. It is a device which produces pressurised air, which is delivered through a nasal or face mask. It should be worn each night during sleep for the 6 month duration of the study. The pressure will vary between individuals. This pressure shall be determined by an overnight titration sleep study at the baseline study visit.
Sponsors
NHMRC Centre for Clinical Research Excellence in respiratory and sleep
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed