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

Primary Purpose

Asthma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CPAP-Continuous Positive Airway Pressure

SHAM

About this trial

This is an interventional basic science trial for Asthma focused on measuring asthma, sleep apnea

Eligibility Criteria

8 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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:

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

Exclusions for adults 18-60 include:

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

Exclusions/Inclusion criteria for adults with asthma include:

Juniper Score <1.5
Baseline FEV1 > or equal to 70%
Non-smoking for 6 months
Less than 10 pack year smoking history
No change in asthma medications for the last 2 months
Negative pregnancy test
Subject cannot have sleep apnea

Sites / Locations

Riley Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CPAP

SHAM

Arm Description

Subjects will use CPAP of 8-12 during days 2 through 6 of the study.

Subjects will use sham CPAP of 0-2 during days 2 through 6 of the study.

Outcomes

Primary Outcome Measures

Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00592631

First Posted

January 2, 2008

Last Updated

January 12, 2016

Sponsor

Indiana University

1. Study Identification

Unique Protocol Identification Number

NCT00592631

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Why Stopped

Key investigator resigned

Study Start Date

February 2005 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Indiana University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

asthma, sleep apnea

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CPAP

Arm Type

Experimental

Arm Description

Subjects will use CPAP of 8-12 during days 2 through 6 of the study.

Arm Title

SHAM

Arm Type

Sham Comparator

Arm Description

Subjects will use sham CPAP of 0-2 during days 2 through 6 of the study.

Intervention Type

Device

Intervention Name(s)

CPAP-Continuous Positive Airway Pressure

Intervention Description

Cpap will be worn at night by subjects 6 to 7 days duration.

Intervention Type

Device

Intervention Name(s)

SHAM

Intervention Description

SHAM will be worn at night by subjects 6 to 7 days duration.

Primary Outcome Measure Information:

Title

Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1)

Description

Time Frame

7 to 10 nights after cpap is started.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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: Cyanotic congenital heart disease. History of acute respiratory symptoms for 3 weeks prior to testing. Inability to perform pulmonary function testing adequately. Escalation in asthma medication at time of recruitment. SaO2 <93% while awake and breathing room air Baseline FEV1 <75% predicted Exclusions for adults 18-60 include: Gastro-Esophageal Reflux requiring Medical management. Chronic Obstructive Pulmonary Disease. Use of Supplemental Oxygen. Ischemic Heart Disease or Hypertension requiring treatment with medications other than diuretics. Use of systemic corticosteroid therapy during the past 6 months. Acute Respiratory Illness in the previous 8 weeks. Exclusions/Inclusion criteria for adults with asthma include: Juniper Score <1.5 Baseline FEV1 > or equal to 70% Non-smoking for 6 months Less than 10 pack year smoking history No change in asthma medications for the last 2 months Negative pregnancy test Subject cannot have sleep apnea

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert S. Tepper, MD, PhD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mike Busk, MD

Organizational Affiliation

NIFS/ Indiana University

Official's Role

Study Director

Facility Information:

Facility Name

Riley Hospital for Children

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22835615

Citation

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.

Results Reference

derived

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

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