Modulation Of Airway Reactivity With Chronic Mechanical Strain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-01-09

Brief Summary

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The purpose of this study is to see if the use of a machine called CPAP will help children with asthma breathe better. CPAP is a machine that produces airflow to help people with breathing problems. To use it, you will wear a mask connected by a hose to the CPAP machine. We believe that use of CPAP may be a treatment for children with asthma.

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Detailed Description

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During the previous funding period of this project, our laboratory demonstrated that chronic mechanical strain imposed on the airways in vivo using continuous positive airway pressure (CPAP) results in a dramatic reduction in airway reactivity in vivo in mice, ferrets and rabbits1-3. Lungs, airways and airway smooth muscle (ASM) tissues isolated from CPAP-treated animals studied in vitro exhibited lower responsiveness to bronchoconstrictors1-3. We also observed this suppression of airway responsiveness by chronic mechanical strain in a rabbit model of allergic asthma5. These animal studies led to a small clinical trial in which adults with asthma were treated with nocturnal CPAP for 1 week. CPAP caused a significant reduction in airway reactivity in these patients6. This novel approach for treating airway hyper-reactivity is currently being evaluated in a NIH multi-center Phase II clinical trial of adults with mild to moderate asthma (U01 HL108730).

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Continuous Positive Airway Pressure (CPAP)

Use of a CPAP machine for at least 5 days per week for 28 days

Group Type EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP)

Intervention Type DEVICE

Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.

Continuous Positive Airway Pressure (CPAP) Sham

Use of a sham CPAP machine for at least 5 days per week for 28 days

Group Type SHAM_COMPARATOR

Continuous Positive Airway Pressure (CPAP) Sham

Intervention Type DEVICE

Subjects assigned to this group will be asked to use the CPAP Sham machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.

Interventions

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Continuous Positive Airway Pressure (CPAP)

Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.

Intervention Type DEVICE

Continuous Positive Airway Pressure (CPAP) Sham

Subjects assigned to this group will be asked to use the CPAP Sham machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children 8-17 yrs olds with severe asthma (N=120) will be recruited from the Pediatric High Risk Asthma Clinic and Pulmonary Clinics at Riley Hospital for Children at Indiana University Health.
* Severe asthma will be defined by the need for medication therapies following steps 4-6 according to the National Institutes of Health's Asthma Care Quick Reference, September 2012 or high dose of inhaled corticosteroids
* On a stable regimen of asthma medications for at least 8 weeks prior to enrollment without systemic corticosteroids for ≥ 4 weeks

Exclusion Criteria

* Obese (\>95% predicted BMI)
* Congenital heart disease or chronic lung disease
* History of pneumothorax
* Inability to perform pulmonary function testing
* Oxygen saturation \<93%
* forced expiratory volume at one second (FEV1) \<70% predicted
* Provocative concentration causing a 20% drop in FEV1 from baseline (PC20) ≥16 mg/ml of methacholine.

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No