Clinical trial NCT02396849: Modulation Of Airway Reactivity With Chronic Mechanical Strain
Official title: Modulation Of Airway Reactivity With Chronic Mechanical Strain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-03-24
Enrollment: 84
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

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.

Primary outcomes:
measure: Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2)
timeFrame: baseline (visit 1) and 4 weeks (visit 2)
Secondary outcomes:
measure: Change in Airway Inflammation From Baseline (Visit 1) and 4 Weeks (Visit 2)
timeFrame: baseline (visit 1) and 4 weeks (visit 2)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: Robert Tepper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Praca E, Jalou H, Krupp N, Delecaris A, Hatch J, Slaven J, Gunst SJ, Tepper RS. Effect of CPAP on airway reactivity and airway inflammation in children with moderate-severe asthma. Respirology. 2019 Apr;24(4):338-344. doi: 10.1111/resp.13441. Epub 2018 Nov 16.