Clinical Trial

Bilevel Positive Airway Pressure (BPAP) for Severe Asthma

Recruiting
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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. 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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-08-13
notable Primary completion pushed: 2027-06 -> 2027-07 2026-08-13
Trial Details
NCT Number NCT07582211
Lead Sponsor Columbia University
Collaborators: Children's Hospital of Philadelphia, Nationwide Children's Hospital, University of Utah, National Heart, Lung, and Blood Institute (NHLBI)
Conditions Pediatric Asthma, Acute Asthma, BiPAP, Non-invasive Positive Pressure Ventilation
Enrollment 36 participants
Start Date 2026-07-20
Primary Completion 2027-07 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-12