Effect of CPAP (Continuous Positive Airway Pressure) on Lung Function in Asthmatics With Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea; Asthma

• Registration Number: NCT00238069
• Lead Sponsor: National Jewish Health

Brief Summary

This is a research study of asthma and sleep apnea. Our hypothesis is that untreated sleep apnea causes inflammation in the lung, which can worsen asthma. We believe treatment of sleep apnea will reduce this inflammation, and improve asthma control. This study will help us better understand what happens to the lung and bronchial tubes before and after treatment of sleep apnea, which could benefit all patients with sleep apnea. This study involves 2 bronchoscopies.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2005-10-11
• Study First Submitted QC: 2005-10-11
• Study First Posted: 2005-10-13
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult (>18yrs at the time of recruitment)
• Body mass index (BMI) ≥ 30
• Symptoms suggestive of sleep apnea
• Epworth Sleepiness Score (ESS) within range
• Positive sleep study for sleep apnea

Exclusion Criteria

• Tobacco use within the last 3 months.
• Presence of other significant comorbid heart or lung disease
• Presence of another chronic inflammatory disease, such as connective-tissue disease, inflammatory bowel disease, or active infection.
• Use of systemic steroids, as defined as any prednisone use in the preceding 3 months.
• Use of leukotriene antagonists or theophylline within the preceding 6 weeks.
• Presence of severe or uncontrolled sinusitis, such that CPAP therapy will be difficult or uncomfortable.
• History of significant claustrophobia, uncontrolled psychiatric disease, or anticipated intolerance of CPAP therapy.
• Night shift workers, or other subjects with significantly altered sleep-wake cycles.
• Baseline post-bronchodilator FEV1 < 70% predicted.
• Severe gastroesophageal reflux disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.
Endobronchial biopsies to analyze extent and type of inflammatory cell.
Exhaled breath condensate levels of IL-6 and 8-isporostane will be measured.
BAL (bronchial lavage) fluid cell count and differential, IL-6, IL-8, and TNF- α will be measured.

Secondary Outcome Measures

Name	Time	Method
Post-CPAP methacholine for bronchial hyperreactivity
Symptoms, albuterol use and daily morning and evening peak expiratory flows from diary cards.
Spirometry measured at three time points: before, during, and after CPAP therapy.

Trial Locations

Locations (1)

National Jewish Medical and Research Center; 🇺🇸 Denver, Colorado, United States