Bilevel Positive Airway Pressure (BPAP) for Severe Asthma

NCT07582211 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: ACYY16201R34HL173384-01A1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to assess the feasibility of early initiation of bilevel positive airway pressure (BPAP) in the emergency department (ED) for children with severe asthma exacerbations. It will also collect preliminary data on the safety and potential effectiveness of this approach. The main questions it aims to answer are:

1. 1.Can eligible patients be successfully enrolled and complete study procedures across multiple sites?
2. 2.What safety events occur with early BPAP use in this population?
3. 3.How do clinical outcomes (such as symptom improvement and need for intensive care) compare between early BPAP and standard care?

Conditions

Pediatric Asthma; Acute Asthma; BiPAP; Non-invasive Positive Pressure Ventilation

Outcome Measures

Primary Outcomes (2)

• Number of eligible patients who consent

  Proportion of approached, eligible patients who provide consent.

  From screening through randomization, up to 2 hours

• Proportion of participants who adhere to the BPAP protocol among all those assigned to the BPAP arm

  Proportion of participants in the intervention arm who receive \> 1 hour \& 45 minutes of BPAP during the planned 2-hour intervention period without unplanned interruption (\> 15 consecutive minutes), unless weaned off continuous albuterol.

  From randomization through end of 2-hour intervention

Secondary Outcomes (12)

• Potential efficacy outcome: Change in Pediatric Respiratory Assessment Measure (PRAM) score

  Pre-intervention to end of intervention, approximately 3 hours total

• Potential efficacy outcome: Duration of continuous albuterol use

  From randomization through hospital discharge beyond the intervention period, up to 120 hours.

• Potential efficacy outcome: Duration of BPAP use

  From randomization through hospital discharge beyond the intervention period, up to 120 hours

• Potential efficacy outcome: PICU admission

  Disposition determined 2 hours after completion of the intervention period

• Potential efficacy outcome: Hospital admission

  Disposition determined 2 hours after completion of the intervention period

Study Arms (2)

BPAP plus continuous albuterol

EXPERIMENTAL

Participants randomized to this arm will receive BPAP plus continuous albuterol administered via FDA-approved delivery systems according to routine clinical practice. BPAP will be delivered using an appropriately sized nasal or face mask and managed by trained respiratory therapists and/or nursing staff per standard care. Continuous albuterol will be administered through the BPAP circuit per manufacturer recommendations or site-specific practice. BPAP settings may be adjusted at the discretion of the treating clinician. Participants will remain on BPAP for approximately 2 hours or until continuous albuterol is discontinued, whichever occurs first. After the intervention period, continuation of BPAP will be at the treating clinical team's discretion.

Device: Bilevel positive airway pressure ventilation

Continuous albuterol alone

NO INTERVENTION

Participants randomized to this arm will receive continuous albuterol administered via FDA-approved delivery systems according to routine clinical practice. Non-invasive ventilation (including BPAP or CPAP) will not be initiated during the first approximately 2 hours after randomization unless clinically indicated; if initiated, the reason will be documented. All other aspects of care, including oxygen and adjunctive therapies, will be provided at the discretion of the treating clinical team per standard practice. After the intervention period, escalation of care, including initiation of BPAP or other respiratory support, will be determined by the treating clinician.

Interventions

Bilevel positive airway pressure ventilation DEVICE

This study involves non-invasive positive pressure ventilation (NIPPV) delivered as bilevel positive airway pressure (BPAP) in children aged 5-17 years presenting to the pediatric emergency department with severe asthma exacerbations. BPAP will be administered using FDA-cleared devices according to their intended use and standard clinical practice. Therapy will be delivered via an appropriately fitted nasal or face mask and managed by trained clinical staff. Ventilator settings will be adjusted at the discretion of the treating clinician, and continuous bronchodilator therapy may be delivered through the BPAP circuit per manufacturer recommendations or site practice.

BPAP plus continuous albuterol

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation.
• Demonstrate moderate-severe asthma exacerbation at triage (i.e., receive an institutional asthma score equivalent to moderate-severe asthma exacerbation or a Pediatric Respiratory Assessment Measure (PRAM) score of 6 or above).

You may not qualify if:

• Prior participation in the study.
• Use of BPAP at any time within approximately 12 hours for this acute asthma exacerbation, including in prehospital, ED, or inpatient settings, prior to randomization.
• Receipt of continuous albuterol for over 150 minutes prior to being approached for consent.
• If a blood gas is obtained, PaCO2 greater than 60 mmHg on the most recent blood gas prior to being approached for consent.
• Note: Blood gas values are not required for eligibility confirmation.
• Anticipated immediate need (i.e., within approximately an hour after completion of first-line therapy) for invasive mechanical ventilation (e.g., endotracheal tube or laryngeal mask airway) or non-invasive mechanical ventilation (e.g., continuous positive airway pressure (CPAP) or BPAP), as determined by the treating physician.
• Presence of a tracheostomy or a baseline requirement for noninvasive ventilation.
• Wheezing due to non-asthma causes (e.g., foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, or anaphylaxis).
• Absolute or relative contraindication to BPAP, defined as any of the following:
• Facial trauma within the area where the face mask would be applied for BPAP (excluding minor abrasion or cuts on forehead or skull).
• Uncontrollable vomiting (i.e., \> 3 episodes within approximately 1 hour prior to being approached for consent).
• Hypotension for age, defined as systolic blood pressure (SBP) less than 70 plus twice the patient's age in years (i.e., SBP \< 70 + \[2 x age in years\]).
• Glasgow Coma Score of 8 or less.
• Known or clinical suspicion for air leak syndrome (e.g., pneumothorax, pneumomediastinum, pneumopericardium, or subcutaneous emphysema).
• Weight \< 20 kg.

Sponsors & Collaborators

• Columbia University: lead
• Children's Hospital of Philadelphia: collaborator
• Nationwide Children's Hospital: collaborator
• University of Utah: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Central Study Contacts

Maria Kwok, MD, MPH

CONTACT

917-375-2647; myk2102@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics (in Emergency Medicine)

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)