Bilevel Positive Airway Pressure (BPAP) for Severe Asthma (NCT07582211) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
United States36 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
5 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 5 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).
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it expects to start enrolling, and would it even be worth considering for my child's current situation given the timing?
2Since this appears to be a feasibility study measuring consent rates and whether kids actually follow through with the BPAP protocol rather than whether BPAP itself improves outcomes, what does that mean for what we'd actually learn about whether it helps my child?
3BPAP involves wearing a mask that delivers pressurized air during a severe asthma attack — how realistic is it that a child in the middle of an acute episode could tolerate that, and what happens if my child can't stay compliant with the mask during the study?
4Given that this trial is in an early feasibility phase and isn't yet measuring clinical outcomes like breathing improvement or hospital stay length, is there a more established treatment path we should be pursuing first instead of waiting for or joining this study?
5If my child were assigned to the non-BPAP arm of this trial, what treatment would they receive instead, and would that be the same as standard care they'd get outside the study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of eligible patients who consent
Timeframe: From screening through randomization, up to 2 hours
2
Proportion of participants who adhere to the BPAP protocol among all those assigned to the BPAP arm
Timeframe: From randomization through end of 2-hour intervention
. If a blood gas is obtained, PaCO2 greater than 60 mmHg on the most recent blood gas prior to being approached for consent.
. 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: