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

January 12, 2016 updated by: Indiana University

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 to 10 nights after cpap is started.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Robert S. Tepper, MD, PhD, Indiana University
  • Study Director: Mike Busk, MD, NIFS/ Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 2, 2008

First Submitted That Met QC Criteria

January 11, 2008

First Posted (Estimate)

January 14, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0405-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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