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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00592631
• Other study ID #: 0405-16
• Secondary ID: 0405-16
• Status: Terminated
• Phase: N/A
• First received: January 2, 2008
• Last updated: January 12, 2016
• Start date: February 2005
• Est. completion date: June 2012

Study information

• Verified date: January 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• CPAP-Continuous Positive Airway Pressure
Cpap will be worn at night by subjects 6 to 7 days duration.
• SHAM
SHAM will be worn at night by subjects 6 to 7 days duration.

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 to 10 nights after cpap is started.	No