Modulation Of Airway Reactivity With Chronic Mechanical Strain

Asthma Clinical Trial

Official title:

Modulation Of Airway Reactivity With Chronic Mechanical Strain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396849
• Other study ID #: 4689673
• Secondary ID: 5R01HL048522
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: January 9, 2020

Study information

• Verified date: February 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 9, 2020
• Est. primary completion date: January 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• 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.
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2)	The change in airway reactivity measured prior to and after 4 weeks of either CPAP or SHAM treatment. Methacholine bronchial challenge was performed using the 5-breath protocol (DeVilbiss646 with KoKo dosimeter: 9 µL/breath) with quadrupling concentrations starting with 0.0625 mg/mL and continuing until FEV1 decreased by 20% (PC20) or Methacholine concentration of 16 mg/mL was inhaled.	baseline (visit 1) and 4 weeks (visit 2)
Secondary	Change in Airway Inflammation From Baseline (Visit 1) and 4 Weeks (Visit 2)	Airway Inflammation assessed as the change in the percentage eosinophils in the induced sputum measured prior to and after 4 weeks of Continuous Positive Airway Pressure (CPAP) or sham CPAP treatment.	baseline (visit 1) and 4 weeks (visit 2)