Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Eligible age
5–17 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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.
Sponsor: Columbia University
You may qualify if…
- ✓ 1. 5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation.
- ✓ 2. 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…
- ✕ 1. Prior participation in the study.
- ✕ 2. 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.
- ✕ 3. Receipt of continuous albuterol for over 150 minutes prior to being approached for consent.
- ✕ 4. 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.
- ✕ 5. 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.
- ✕ 6. Presence of a tracheostomy or a baseline requirement for noninvasive ventilation.
- ✕ 7. Wheezing due to non-asthma causes (e.g., foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, or anaphylaxis).
Where it's recruiting
Source: ClinicalTrials.gov · NCT07582211 · last updated 2026-08-18