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Clinical Trials/ACTRN12608000348358
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.

Registry
who.int
Start Date
July 23, 2008
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
HMRC Centre for Clinical Research Excellence in respiratory and sleep

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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