Modulation Of Airway Reactivity With Chronic Mechanical Strain

NCT02396849 | Completed Results DMC

• 2 other identifiers: 46896735R01HL048522
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Airway Inflammation From Baseline (Visit 1) and 4 Weeks (Visit 2)

  baseline (visit 1) and 4 weeks (visit 2)

Study Arms (2)

Continuous Positive Airway Pressure (CPAP)

EXPERIMENTAL

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

Device: Continuous Positive Airway Pressure (CPAP)

Continuous Positive Airway Pressure (CPAP) Sham

SHAM COMPARATOR

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

Device: Continuous Positive Airway Pressure (CPAP) Sham

Interventions

Continuous Positive Airway Pressure (CPAP) 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)

Continuous Positive Airway Pressure (CPAP) Sham 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.

Continuous Positive Airway Pressure (CPAP) Sham

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 30444283 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Limitations and Caveats

We evaluated only children with moderate-severe asthma, the results cannot be extrapolated to children with mild or moderate asthma. A major limitation of our study was the limited number of subjects we could recruit from a single pediatric center. Our evaluation of airway inflammation was limited to induced sputum rather than bronchoalveolar lavage, which would not have been an acceptable risk in our children.

Results Point of Contact

• Title: Christina Tiller
• Organization: Indiana University

ctiller@iu.edu

317-044-4522

Study Officials

• Robert Tepper, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Robert Tepper

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: January 1, 2015
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: March 9, 2021
• Results First Posted: February 18, 2021

Record last verified: 2021-02

Locations

US (1)