Asthma in ChildrenNCT05848115
BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial
A study testing Bi-level Positive Airway Pressure in people with Asthma in Children, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this clinical trial is to study if starting bi-level positive airway pressure (BiPAP), a mask that gives pressure to the lungs, works well for children in the emergency department with moderate to severe asthma attacks. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Bi-level Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2023to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation
- Prior diagnosis of asthma by a physician who prescribed asthma medications (beta-agonist and/or inhaled or oral steroids)
- PRAM score of 4 or greater after administration of first-line therapy (albuterol/ipratropium back to backs, corticosteroids, +/- oxygen) and need for continuous beta-agonist therapy after first-line therapy
Who cannot join
- Prior participation in the study
- Hypercapnic (PaCO2 > 60 mmHg) respiratory failure or need for invasive mechanical ventilation as determined by the treating physician
- Hypoxemic respiratory failure (SaO2 < 90% with fraction of inspired oxygen inspired oxygen fraction (FiO2) > 0.35)
- Presence of a tracheostomy or baseline noninvasive ventilation requirement
- Non-asthma causes of wheezing: foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, anaphylaxis
- Absolute or relative contraindication to BiPAP: facial trauma, uncontrollable vomiting, hypotension for age, Glasgow Coma Score of 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding the Role of Bilevel Positive Airway Pressure (BiPAP) in Pediatric Acute Asthma Exacerbations: A Prospective, Randomized, Double Blind, Controlled Trial
The goal of this clinical trial is to study if starting bi-level positive airway pressure (BiPAP), a mask that gives pressure to the lungs, works well for children in the emergency department with moderate to severe asthma attacks. The main questions it aims to answer are:
- Whether initiation of BiPAP at the same time as continuous beta-agonist therapy (e.g., nebulized albuterol) will decrease how long children with moderate to severe asthma attacks need to receive continuous beta-agonist therapy.
- Whether early BiPAP changes how the lungs function in children with asthma attacks.
- Whether children receiving early BiPAP experience more issues or side effects than those children who do not.
Read more
All children will receive the usual treatment for asthma attacks; if they are still experiencing moderate to severe symptoms after the initial treatment, they will be asked to participate in the study. Participants will then wear a mask while they are receiving the continuous beta-agonist therapy. Some patients will receive BiPAP where pressure is given to the lungs and others will have a sham BiPAP mask where no pressure is given to the lungs. Study participants will wear the mask for 4 hours or until their treatment team feels they are ready to come off of the continuous beta-agonist therapy. Participants will receive more medications and decisions on going home or being admitted to the hospital will be decided as usual by their treatment team.
Researchers will compare BiPAP versus Control (Sham BiPAP) groups to see if there is a difference in how long continuous beta-agonist therapy is needed, how the lungs are functioning, and number or type of side effects.
- Conditions
- Asthma in Children
- Being tested
- Bi-level Positive Airway Pressure, Sham Bi-level Positive Airway Pressure
- Keywords
- Pediatric Asthma, Asthma, Bi-level Positive Airway Pressure, BiPAP, Beta-Agonist
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-level Positive Airway PressureDevice
Also called BiPAP
An appropriately sized vented BiPAP face mask with a good seal will be applied and monitored by trained respiratory therapists. Patients will be started on an inspiratory peak airway pressure (IPAP) of 10 cm of water and expiratory positive airway pressure (EPAP) of 5 cm of water per Children's Hospital Colorado (CHCO) clinical pathway. BiPAP pressures will be titrated to effect per the treating physician, using assessment of physical examination, vitals, and asthma score per institutional clinical pathway. Study participants will remain on BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. After the four-hour intervention period, it is at the discretion of the treating clinician regarding the ongoing use of BiPAP or not.
Sham Bi-level Positive Airway PressureDevice
Also called Sham BiPAP
The sham BiPAP will have pressure attenuated using an orifice restrictor as described in previous double blinded studies using sham non-invasive ventilation. With this set-up pressures no greater than 2 cm of water have been documented at the location of the face mask. This will ensure that the patient is not receiving positive pressure with any effectiveness or deleterious effects. Study participants will remain on sham BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. After the four-hour intervention period, it is at the discretion of the treating clinician regarding the use of BiPAP or not.
| Study group | Role | What they receive |
|---|---|---|
| BiPAP | Experimental | Patients randomized to the study group (BiPAP) will receive continuous nebulized albuterol through the FDA approved Respironics Trilogy BiPAP machine as per routine practice and institutional guidelines for albuterol dosing. Participants will receive BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. Receives: Device: Bi-level Positive Airway Pressure |
| Control | Sham comparator | Patients randomized to the control group (sham BiPAP) will receive continuous nebulized albuterol through the same set-up as the study group and institutional guidelines for albuterol dosing. Participants will remain on sham BiPAP for four hours or until weaned off continuous beta-agonist therapy per the treating clinician. Receives: Device: Sham Bi-level Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Continuous Beta-Agonist Therapy
Number of hours until discontinuation of continuous beta-agonist therapy
Measured: Through study completion, an average of 24 hours
Secondary outcomes (10)
Change in Pediatric Respiratory Assessment Measure (PRAM)
Change in Pediatric Respiratory Assessment Measure (PRAM) from baseline to two and four hours, minimum score of 0 and maximum score of 12, the higher the score the more severe the disease
Measured: At two and four hours after starting the intervention
Change in Respiratory Rate
Change in respiratory rate in breaths per minute from baseline to two and four hours
Measured: At two and four hours after starting the intervention
Invasive Mechanical Ventilation
Rate of participants requiring endotracheal intubation for invasive mechanical ventilation
Measured: Four-hour study intervention
Admission to Pediatric Intensive Care Unit (PICU)
Rate of admissions to the Pediatric Intensive Care Unit (PICU)
Measured: Through entire hospitalization, an average of 72 hours
Total Length of Stay in Hospital
Total length of stay in hours in the Emergency Department (ED), Pediatric Intensive Care Unit (PICU), and hospital floor
Measured: Through entire hospitalization, an average of 72 hours
Hospital Readmissions
Rate of hospital readmission within 7 days
Measured: 7 days from hospital discharge date
Duration of Bilevel Positive Airway Pressure (BiPAP)
Duration in hours of BiPAP administration
Measured: Through entire hospitalization, an average of 72 hours
Adverse Events
Pneumothorax, pneumomediastinum, sub-cutaneous emphysema, hypotension, vomiting, aspiration, skin breakdown
Measured: Four-hour study intervention
Change in Pulse Oxygen Saturation
Change in pulse oxygen saturation (range from 0 to 100%) from baseline to two and four hours
Measured: At 2 hour and 4 hours after starting the intervention
Change in Heart Rate
Change in heart rate in beats per minute from baseline to two and four hours
Measured: At 2 hour and 4 hours after starting the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start23 Jun 2023
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Why it stopped: Interim Analysis showed futility for the primary outcome measure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Patrick T Wilson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848115
- Sponsor's protocol ID
- 22-2338
- Other IDs
- 1R61HL158814-01A1
- Status last verified
- Aug 2025
- First submitted
- 13 Apr 2023
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures, and appendices).
Publications
Wilson PT, Tanverdi M, Brinton JT, Ambroggio L, Szefler SJ. Bilevel Positive Airway Pressure and Continuous Albuterol for Pediatric Asthma Exacerbations: A Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2630627. doi: 10.1001/jamanetworkopen.2026.30627.
PubMed 42646841
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of Bilevel Positive Airway Pressure (BiPAP) in Pediatric Acute Asthma Exacerbations: A Prospective, Randomized, Double Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT05848115
- Acronym / sponsor ID
- 22-2338
- Conditions
- Asthma in Children
- Keywords
- Pediatric Asthma, Asthma, Bi-level Positive Airway Pressure, BiPAP, Beta-Agonist
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim Analysis showed futility for the primary outcome measure.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to study if starting bi-level positive airway pressure (BiPAP), a mask that gives pressure to the lungs, works well for children in the emergency department with moderate to severe asthma attacks. The main questions it aims to answer are:
- Whether initiation of BiPAP at the same time as continuous beta-agonist therapy (e.g., nebulized albuterol) will decrease how long children with moderate to severe asthma attacks need to receive continuous beta-agonist therapy.
- Whether early BiPAP changes how the lungs function in children with asthma attacks.
- Whether children receiving early BiPAP experience more issues or side effects than those children who do not.
All children will receive the usual treatment for asthma attacks; if they are still experiencing moderate to severe symptoms after the initial treatment, they will be asked to participate in the study. Participants will then wear a mask while they are receiving the continuous beta-agonist therapy. Some patients will receive BiPAP where pressure is given to the lungs and others will have a sham BiPAP mask where no pressure is given to the lungs. Study participants will wear the mask for 4 hours or until their treatment team feels they are ready to come off of the continuous beta-agonist therapy. Participants will receive more medications and decisions on going home or being admitted to the hospital will be decided as usual by their treatment team.
Researchers will compare BiPAP versus Control (Sham BiPAP) groups to see if there is a difference in how long continuous beta-agonist therapy is needed, how the lungs are functioning, and number or type of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiPAP | Experimental | Device: Bi-level Positive Airway PressurePatients randomized to the study group (BiPAP) will receive continuous nebulized albuterol through the FDA approved Respironics Trilogy BiPAP machine as per routine practice and institutional guidelines for albuterol dosing. Participants will receive BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. |
| Control | Sham comparator | Device: Sham Bi-level Positive Airway PressurePatients randomized to the control group (sham BiPAP) will receive continuous nebulized albuterol through the same set-up as the study group and institutional guidelines for albuterol dosing. Participants will remain on sham BiPAP for four hours or until weaned off continuous beta-agonist therapy per the treating clinician. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation
- Prior diagnosis of asthma by a physician who prescribed asthma medications (beta-agonist and/or inhaled or oral steroids)
- PRAM score of 4 or greater after administration of first-line therapy (albuterol/ipratropium back to backs, corticosteroids, +/- oxygen) and need for continuous beta-agonist therapy after first-line therapy
Key exclusion criteria (6 listed)
- Prior participation in the study
- Hypercapnic (PaCO2 > 60 mmHg) respiratory failure or need for invasive mechanical ventilation as determined by the treating physician
- Hypoxemic respiratory failure (SaO2 < 90% with fraction of inspired oxygen inspired oxygen fraction (FiO2) > 0.35)
- Presence of a tracheostomy or baseline noninvasive ventilation requirement
- Non-asthma causes of wheezing: foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, anaphylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bi-level Positive Airway PressureAlso: BiPAPAn appropriately sized vented BiPAP face mask with a good seal will be applied and monitored by trained respiratory therapists. Patients will be started on an inspiratory peak airway pressure (IPAP) of 10 cm of water and expiratory positive airway pressure (EPAP) of 5 cm of water per Children's Hospital Colorado (CHCO) clinical pathway. BiPAP pressures will be titrated to effect per the treating physician, using assessment of physical examination, vitals, and asthma score per institutional clinical pathway. Study participants will remain on BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. After the four-hour intervention period, it is at the discretion of the treating clinician regarding the ongoing use of BiPAP or not. | Device | BiPAP |
| Sham Bi-level Positive Airway PressureAlso: Sham BiPAPThe sham BiPAP will have pressure attenuated using an orifice restrictor as described in previous double blinded studies using sham non-invasive ventilation. With this set-up pressures no greater than 2 cm of water have been documented at the location of the face mask. This will ensure that the patient is not receiving positive pressure with any effectiveness or deleterious effects. Study participants will remain on sham BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. After the four-hour intervention period, it is at the discretion of the treating clinician regarding the use of BiPAP or not. | Device | Control |
Primary outcome
Duration of Continuous Beta-Agonist Therapy
Time frame: Through study completion, an average of 24 hours
Number of hours until discontinuation of continuous beta-agonist therapy
10 secondary outcomes
Change in Pediatric Respiratory Assessment Measure (PRAM)
Time frame: At two and four hours after starting the intervention
Change in Respiratory Rate
Time frame: At two and four hours after starting the intervention
Invasive Mechanical Ventilation
Time frame: Four-hour study intervention
Admission to Pediatric Intensive Care Unit (PICU)
Time frame: Through entire hospitalization, an average of 72 hours
Total Length of Stay in Hospital
Time frame: Through entire hospitalization, an average of 72 hours
Hospital Readmissions
Time frame: 7 days from hospital discharge date
Duration of Bilevel Positive Airway Pressure (BiPAP)
Time frame: Through entire hospitalization, an average of 72 hours
Adverse Events
Time frame: Four-hour study intervention
Change in Pulse Oxygen Saturation
Time frame: At 2 hour and 4 hours after starting the intervention
Change in Heart Rate
Time frame: At 2 hour and 4 hours after starting the intervention
Results and safety
The study was stopped early (reason given: Interim Analysis showed futility for the primary outcome measure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 42646841Wilson PT, Tanverdi M, Brinton JT, Ambroggio L, Szefler SJ. Bilevel Positive Airway Pressure and Continuous Albuterol for Pediatric Asthma Exacerbations: A Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2630627. doi: 10.1001/jamanetworkopen.2026.30627.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick T Wilson, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-level Positive Airway Pressure in people with Asthma in Children, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim Analysis showed futility for the primary outcome measure.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Continuous Beta-Agonist Therapy (time frame: Through study completion, an average of 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05848115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.