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

This study has been terminated.
(Key investigator resigned)
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00592631
First received: January 2, 2008
Last updated: January 12, 2016
Last verified: January 2016
  Purpose
We hypothesize that the nocturnal use of continuous positive airway pressure in adults and children with asthma will decrease airway reactivity.

Condition Intervention
Asthma
Device: CPAP-Continuous Positive Airway Pressure
Device: SHAM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: February 2005
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPAP
Subjects will use CPAP of 8-12 during days 2 through 6 of the study.
Device: CPAP-Continuous Positive Airway Pressure
Cpap will be worn at night by subjects 6 to 7 days duration.
Sham Comparator: SHAM
Subjects will use sham CPAP of 0-2 during days 2 through 6 of the study.
Device: SHAM
SHAM will be worn at night by subjects 6 to 7 days duration.

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.
  Eligibility

Ages Eligible for Study:   8 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00592631

Locations
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Robert S. Tepper, MD, PhD Indiana University
Study Director: Mike Busk, MD NIFS/ Indiana University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00592631     History of Changes
Other Study ID Numbers: 0405-16 
Study First Received: January 2, 2008
Results First Received: November 12, 2015
Last Updated: January 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
asthma
sleep apnea

ClinicalTrials.gov processed this record on May 04, 2016