Bilevel Positive Airway Pressure (BPAP) for Severe Asthma

Conditions

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

Eligibility Criteria

Sex

ALL

Age

5 Years - 17 Years

Healthy Volunteers

Not accepted

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.

Study Details

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. Can eligible patients be successfully enrolled and complete study procedures across multiple sites? 2. What safety events occur with early BPAP use in this population? 3. How do clinical outcomes (such as symptom improvement and need for intensive care) compare between early BPAP and standard care? Researchers will compare early initiation of BPAP plus standard asthma therapy to standard asthma therapy alone to determine whether early BPAP is a feasible and potentially beneficial treatment strategy. Participants will 1) receive standard asthma therapy with or without early BPAP in the ED, 2) be monitored closely during the ED visit and hospitalization, and 3) have clinical data collected from routine care, including asthma severity scores, treatments, and outcomes. The study will enroll approximately 36 participants (about 12 per site) across three sites over one year to inform a future multicenter randomized controlled trial.

Key Dates

Start date

Jun 30, 2026

Status verified

May 2026

Primary completion

Jun 30, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BPAP plus continuous albuterol
  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.
• No Intervention: Continuous albuterol alone
  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.

Primary Outcome Measure

Number of eligible patients who consent [ Time Frame: From screening through randomization, up to 2 hours ]

Central Contacts

• Maria Kwok, MD, MPH
  917-375-2647
  [email protected]

Locations (3)

Find similar trials in New York, NY

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