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

Asthma Clinical Trial

Official title:

Effect of CPAP (Continuous Positive Airway Pressure) on Airway Inflammation in Asthmatics With Sleep-Disordered Breathing: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238069
• Other study ID #: HS-1866
• Status: Completed
• Phase: N/A
• First received: October 11, 2005
• Last updated: March 27, 2017
• Start date: December 2004
• Est. completion date: August 2005

Study information

• Verified date: March 2017
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Asthma
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• CPAP machine as a result of sleep study

Locations

Country	Name	City	State
United States	National Jewish Medical and Research Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-a.
Primary	Exhaled breath condensate levels of IL-6 and 8-isporostane will be measured.
Primary	BAL (bronchial lavage) fluid cell count and differential, IL-6, IL-8, and TNF- a will be measured.
Primary	Endobronchial biopsies to analyze extent and type of inflammatory cell.
Secondary	Symptoms, albuterol use and daily morning and evening peak expiratory flows from diary cards.
Secondary	Spirometry measured at three time points: before, during, and after CPAP therapy.
Secondary	Post-CPAP methacholine for bronchial hyperreactivity

External Links

•   clinical lab website within National Jewish Medical and Research Center