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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

Study Description
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Brief Summary:
We hypothesize that the nocturnal use of continuous positive airway pressure in adults and children with asthma will decrease airway reactivity.

Condition or disease Intervention/treatment Phase
Asthma Device: CPAP-Continuous Positive Airway Pressure Device: SHAM Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2005
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592631


Locations
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United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Robert S. Tepper, MD, PhD Indiana University
Study Director: Mike Busk, MD NIFS/ Indiana University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00592631    
Other Study ID Numbers: 0405-16
0405-16
First Posted: January 14, 2008    Key Record Dates
Results First Posted: February 10, 2016
Last Update Posted: February 10, 2016
Last Verified: January 2016
Keywords provided by Indiana University:
asthma
sleep apnea
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases