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

This study has been completed.
Sponsor:
Information provided by:
National Jewish Health
ClinicalTrials.gov Identifier:
NCT00238069
First received: October 11, 2005
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Asthma
Sleep Apnea
Device: CPAP machine as a result of sleep study

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of CPAP (Continuous Positive Airway Pressure) on Airway Inflammation in Asthmatics With Sleep-Disordered Breathing: A Pilot Study

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.
  • 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.
  • Endobronchial biopsies to analyze extent and type of inflammatory cell.

Secondary Outcome Measures:
  • 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.
  • Post-CPAP methacholine for bronchial hyperreactivity

Estimated Enrollment: 20
Study Start Date: December 2004
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238069

Locations
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Investigators
Principal Investigator: Richard Martin, MD National Jewish Medical and Research Center faculty
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00238069     History of Changes
Other Study ID Numbers: HS-1866
Study First Received: October 11, 2005
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by National Jewish Health:
Asthma
Sleep Apnea
Obesity
CPAP

Additional relevant MeSH terms:
Apnea
Asthma
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2014