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Assessment Of The Effects Of Short and Long Term Use Of CPAP

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ClinicalTrials.gov Identifier: NCT00592631
Recruitment Status : Terminated (Key investigator resigned)
First Posted : January 14, 2008
Results First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Indiana University

Tracking Information
First Submitted Date  ICMJE January 2, 2008
First Posted Date  ICMJE January 14, 2008
Results First Submitted Date  ICMJE November 12, 2015
Results First Posted Date  ICMJE February 10, 2016
Last Update Posted Date February 10, 2016
Study Start Date  ICMJE February 2005
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 7 to 10 nights after cpap is started. ]
Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
The reactivity of the airway will be decreased proven by Methacholine challenge. [ Time Frame: 6 to 7 nights after cpap is started. ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment Of The Effects Of Short and Long Term Use Of CPAP
Official Title  ICMJE Assessment of the Effects of Short and Long Term Use of Continuous Positive Airway Pressure on Airway Reactivity in Children and Adults With and Without Asthma
Brief Summary We hypothesize that the nocturnal use of continuous positive airway pressure in adults and children with asthma will decrease airway reactivity.
Detailed Description Deep inspirations have been shown to decrease the sensitivity of airways to narrowing (airway reactivity) after inhalation of agents that induce constriction of the bronchi in healthy adults. This response is absent in adult asthmatics; however, there is data demonstrating that use of continuous positive airway pressure (CPAP) for short periods of time may decrease airway reactivity in adult asthmatics. This suggests that although deep inspirations may not result in decreased airway reactivity, sustained lung inflation may lead to changes in asthmatic airway smooth muscle structure that lead to a decrease in airway reactivity. The purpose of our study is to determine whether short and long term use of CPAP in children and adults leads to decreased airway reactivity. If airway reactivity is decreased with CPAP, this may provide a novel therapeutic strategy for patients with asthma.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Asthma
Intervention  ICMJE
  • Device: CPAP-Continuous Positive Airway Pressure
    Cpap will be worn at night by subjects 6 to 7 days duration.
  • Device: SHAM
    SHAM will be worn at night by subjects 6 to 7 days duration.
Study Arms  ICMJE
  • Experimental: CPAP
    Subjects will use CPAP of 8-12 during days 2 through 6 of the study.
    Intervention: Device: CPAP-Continuous Positive Airway Pressure
  • Sham Comparator: SHAM
    Subjects will use sham CPAP of 0-2 during days 2 through 6 of the study.
    Intervention: Device: SHAM
Publications * Busk M, Busk N, Puntenney P, Hutchins J, Yu Z, Gunst SJ, Tepper RS. Use of continuous positive airway pressure reduces airway reactivity in adults with asthma. Eur Respir J. 2013 Feb;41(2):317-22. doi: 10.1183/09031936.00059712. Epub 2012 Jul 26.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 12, 2016)
27
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2008)
60
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion criteria for children 8-18

  • Children 8-18 years of age scheduled to start CPAP for obstructive sleep apnea.
  • Subjects can have clinically stable asthma, with no plans by their physician to change asthma therapy over the next month

Inclusion criteria adults 18-60

  • Adults 18-60 years of age, seen in adult Pulmonary Clinic for sleep related problems who may require treatment with nocturnal continuous positive pressure (CPAP), which will be determined by polysomnography(PSG) will be approached to participate in the study.

Exclusion Criteria:

Exclusions for Children category age 8-18 include:

  1. Cyanotic congenital heart disease.
  2. History of acute respiratory symptoms for 3 weeks prior to testing.
  3. Inability to perform pulmonary function testing adequately.
  4. Escalation in asthma medication at time of recruitment.
  5. SaO2 <93% while awake and breathing room air
  6. Baseline FEV1 <75% predicted

Exclusions for adults 18-60 include:

  1. Gastro-Esophageal Reflux requiring Medical management.
  2. Chronic Obstructive Pulmonary Disease.
  3. Use of Supplemental Oxygen.
  4. Ischemic Heart Disease or Hypertension requiring treatment with medications other than diuretics.
  5. Use of systemic corticosteroid therapy during the past 6 months.
  6. Acute Respiratory Illness in the previous 8 weeks.

Exclusions/Inclusion criteria for adults with asthma include:

  1. Juniper Score <1.5
  2. Baseline FEV1 > or equal to 70%
  3. Non-smoking for 6 months
  4. Less than 10 pack year smoking history
  5. No change in asthma medications for the last 2 months
  6. Negative pregnancy test
  7. Subject cannot have sleep apnea
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 60 Years   (Child, 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 NCT00592631
Other Study ID Numbers  ICMJE 0405-16
0405-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert S. Tepper, MD, PhD Indiana University
Study Director: Mike Busk, MD NIFS/ Indiana University
PRS Account Indiana University
Verification Date January 2016

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