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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00238069
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:
National Jewish Health

Tracking Information
First Submitted Date  ICMJE October 11, 2005
First Posted Date  ICMJE October 13, 2005
Last Update Posted Date March 29, 2017
Study Start Date  ICMJE December 2004
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2005)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of CPAP (Continuous Positive Airway Pressure) on Lung Function in Asthmatics With Sleep Apnea
Official Title  ICMJE Effect of CPAP (Continuous Positive Airway Pressure) on Airway Inflammation in Asthmatics With Sleep-Disordered Breathing: A Pilot Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Sleep Apnea
Intervention  ICMJE Device: CPAP machine as a result of sleep study
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2005)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2005
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00238069
Other Study ID Numbers  ICMJE HS-1866
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Jewish Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Martin, MD National Jewish Medical and Research Center faculty
PRS Account National Jewish Health
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP