N/A N=59 Randomized Single-blind Treatment

Modulation Of Airway Reactivity With Chronic Mechanical Strain

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT02396849 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2) — 3.0; 3.2; 5.3; 4.3 mg/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Continuous Positive Airway Pressure (CPAP) (Device); Continuous Positive Airway Pressure (CPAP) Sham (Device)
Age: Pediatric · 8+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2)	3.0; 3.2; 5.3; 4.3	—
SECONDARY Change in Airway Inflammation From Baseline (Visit 1) and 4 Weeks (Visit 2)	6.2; 3.9; 3.6; 5.4	—

Summary

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02396849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.