BiPAP for Childhood Asthma

Overseen By Alec Edid

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Beta-agonists, Steroids

Disqualifiers: Respiratory failure, Tracheostomy, Non-asthma wheezing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 hours

126 Participants Needed

Trial Summary

What is the purpose of this 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: 1. 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. 2. Whether early BiPAP changes how the lungs function in children with asthma attacks. 3. 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.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. It seems you will continue with your usual asthma treatments while participating.

What data supports the effectiveness of the treatment BiPAP for childhood asthma?

Research suggests that BiPAP, a type of breathing support, can be safe and possibly beneficial for children with severe asthma who do not respond to regular treatments. It has been shown to help with breathing in children with acute asthma, although more evidence is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is BiPAP generally safe for children with asthma?

Research shows that BiPAP is generally safe for children with asthma, as studies have examined its safety and patient tolerance in pediatric patients. ^{2 3 4 5 6}

How is BiPAP treatment different from other treatments for childhood asthma?

BiPAP (Bi-level Positive Airway Pressure) is a non-invasive treatment that helps children with asthma breathe more easily by providing two levels of air pressure, unlike traditional asthma treatments that often rely on medications like inhalers. This approach is unique because it offers mechanical support to the lungs without the need for invasive procedures or drugs. ^{1 2 3 4 5}

Research Team

Patrick T Wilson, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for children aged 5-17 with a prior asthma diagnosis and moderate to severe symptoms after initial treatment. They must have a PRAM score of 4+ and need continuous beta-agonist therapy. Excluded are those with non-asthma wheezing, hypercapnic respiratory failure, previous study participation, hypoxemic respiratory failure, tracheostomy or BiPAP contraindications like facial trauma.

Inclusion Criteria

I am between 5 and 17 years old and have asthma.

I have been diagnosed with asthma and prescribed medication for it.

My asthma is severe, needing continuous treatment even after initial emergency care.

Exclusion Criteria

I need a machine to help me breathe due to high CO2 levels.

I have low oxygen levels despite receiving a significant amount of oxygen.

My wheezing is not caused by asthma but another condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Immediate

Treatment

Participants receive continuous nebulized albuterol and either BiPAP or sham BiPAP for up to 4 hours

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in pulse oxygen saturation, PRAM score, respiratory rate, and adverse events

24 hours

Hospitalization

Participants may be admitted to the hospital for further observation and treatment as needed

Up to 72 hours

Treatment Details

Interventions

• Bi-level Positive Airway Pressure
• Sham Bi-level Positive Airway Pressure

Trial Overview The trial tests if BiPAP alongside standard nebulized albuterol can reduce the duration of beta-agonist therapy needed for kids during an asthma attack. It compares the effectiveness and side effects of actual BiPAP versus sham (fake) BiPAP in improving lung function and reducing treatment time.

Participant Groups

Group I: BiPAP Experimental Treatment 1 Intervention

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.

Group II: Control Placebo Group 1 Intervention

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.

Bi-level Positive Airway Pressure is already approved in United States, Canada, European Union for the following indications:

Approved in United States as BiPAP for:

• Acute asthma exacerbations in children

Approved in Canada as BiPAP for:

• Acute asthma exacerbations in children

Approved in European Union as BiPAP for:

• Acute respiratory failure
• Chronic respiratory failure
• Acute asthma exacerbations in children

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a study of 56 children and adolescents with obstructive sleep apnea, both bilevel positive airway pressure with pressure release technology (Bi-Flex) and standard continuous positive airway pressure (CPAP) were found to be equally effective in reducing apnea events, with no significant differences in efficacy between the two methods.

Despite both treatments being effective, adherence to using the devices was suboptimal for both Bi-Flex and CPAP, indicating a need for further research to improve compliance in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind clinical trial of two different modes of positive airway pressure therapy on adherence and efficacy in children. Marcus, CL., Beck, SE., Traylor, J., et al.[2021]

In a study of 165 children weighing 20 kg or less with moderate to severe asthma exacerbations, BiPAP treatment was found to be safe, with no cases of worsening hypoxia, pneumothorax, or death reported.

BiPAP treatment led to significant clinical improvement, as indicated by a decrease in the pediatric asthma score (PAS) from a mean of 12.1 at initiation to 6.3 at termination, suggesting its potential efficacy in managing acute asthma exacerbations in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and clinical findings of BiPAP utilization in children 20 kg or less for asthma exacerbations. Williams, AM., Abramo, TJ., Shah, MV., et al.[2021]

In a study of 83 pediatric patients with severe asthma (status asthmaticus) who did not respond to standard treatments, 88% tolerated bilevel positive airway pressure (BiPAP) therapy well, indicating its safety and patient acceptance.

The use of BiPAP, combined with beta-2 agonist therapy, led to significant clinical improvements, with 77% of patients showing reduced respiratory rates and 88% experiencing increased oxygen saturation, suggesting it could be a beneficial addition to conventional asthma treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilevel positive airway pressure in the treatment of status asthmaticus in pediatrics. Beers, SL., Abramo, TJ., Bracken, A., et al.[2006]

A meta-analysis of 10 randomized controlled trials involving 558 children showed that noninvasive positive-pressure ventilation (NPPV) significantly improves blood gas parameters and reduces respiratory rates in children with acute asthma compared to conventional treatment alone.

NPPV is associated with a shorter hospital stay and no reported severe adverse events, indicating it is both effective and safe for treating pediatric patients with acute asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive positive-pressure ventilation for children with acute asthma: a meta-analysis of randomized controlled trials. Dai, J., Wang, L., Wang, F., et al.[2023]

In a study of 147 patients with pulmonary edema, early application of BiPAP (within one hour of ER admission) significantly increased the likelihood of being discharged within four hours, with 85% of early BiPAP patients discharged compared to only 15% of those who received it later.

The benefits of early BiPAP application were particularly notable in patients with congestive heart failure, where 84% were discharged within four hours compared to just 16% in the late BiPAP group, highlighting the importance of timely intervention in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of BiLevel Positive Airway Pressure (BiPAP) Application Timing on Emergency Room Length of Stay in Patients With Pulmonary Edema: A Single-Center, Retrospective Cohort Study. Khayat, S., Ali, M., Almasoudi, L., et al.[2023]

In a study of 41 patients with acute exacerbations of COPD, the use of noninvasive ventilatory support (NPPV) with BiPAP significantly improved respiratory rates and consciousness within the first 2 hours compared to standard therapy alone.

Patients receiving NPPV had a lower need for intubation (5% vs 14%) and a shorter hospital stay (7 days vs 10 days), indicating that NPPV is both effective and safe for managing acute hypercapnic respiratory failure in a general respiratory ward.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Noninvasive positive pressure ventilation for acute respiratory failure in chronic obstructive pulmonary disease in a general respiratory ward]. del Castillo, D., Barrot, E., Laserna, E., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized, double-blind clinical trial of two different modes of positive airway pressure therapy on adherence and efficacy in children. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and clinical findings of BiPAP utilization in children 20 kg or less for asthma exacerbations. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Bilevel positive airway pressure in the treatment of status asthmaticus in pediatrics. [2006]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Noninvasive positive-pressure ventilation for children with acute asthma: a meta-analysis of randomized controlled trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Impact of BiLevel Positive Airway Pressure (BiPAP) Application Timing on Emergency Room Length of Stay in Patients With Pulmonary Edema: A Single-Center, Retrospective Cohort Study. [2023]

6. Spain pubmed.ncbi.nlm.nih.gov

[Noninvasive positive pressure ventilation for acute respiratory failure in chronic obstructive pulmonary disease in a general respiratory ward]. [2019]