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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using BiPAP, a mask that helps push air into the lungs, can reduce the time children need intensive asthma treatments in the emergency room. Researchers aim to determine if starting BiPAP alongside usual asthma medications, such as albuterol, improves lung function and if it causes any issues. Children who continue to experience moderate to severe asthma symptoms after initial treatments might be suitable candidates. Participants will receive either the actual BiPAP treatment or a sham version without pressure to compare outcomes. As an unphased trial, this study provides a unique opportunity to enhance understanding and potentially improve emergency asthma care for children.

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 prior data suggests that BiPAP is safe for children with asthma?

Research shows that Bi-level Positive Airway Pressure (BiPAP) is safe and effective for children with asthma. Studies have found that BiPAP helps children breathe better and reduces their hospital stay. During asthma attacks, BiPAP can safely relieve symptoms without serious side effects. Even children weighing 20 kg (about 44 pounds) or less handle BiPAP well during moderate and severe asthma attacks. Thus far, using BiPAP for asthma in children appears to be a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Bi-level Positive Airway Pressure (BiPAP) for childhood asthma because it offers a new approach to managing acute symptoms. Unlike standard treatments like inhaled corticosteroids and bronchodilators, BiPAP provides continuous support to keep the airways open, potentially reducing the need for high doses of medication. This method not only aids in delivering albuterol more effectively but also helps in easing breathing without the invasive procedures often required in severe asthma cases. By using a non-invasive machine, BiPAP could offer quicker relief and improved comfort for young patients struggling with asthma attacks.

What evidence suggests that BiPAP is effective for childhood asthma?

Research has shown that Bi-level Positive Airway Pressure (BiPAP) can help children with sudden asthma attacks breathe more easily and reduce their breathing rate. Studies have found that BiPAP lowers asthma symptoms and shortens hospital stays. In simpler terms, children with asthma attacks might breathe easier and spend less time in the hospital. One study found that BiPAP improved asthma scores in children with moderate to severe symptoms. This trial will compare the effects of BiPAP with a sham BiPAP control to evaluate its effectiveness as an additional treatment for asthma attacks in children. ^{1 3 6 7 8}

Who Is on the Research Team?

Patrick T Wilson, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

Citations

1. link.springer.com link.springer.com/article/10.1007/s00134-011-2238-9

Safety and clinical findings of BiPAP utilization in children ... Overall, BiPAP subjects showed improvement in pediatric asthma score (PAS). BiPAP initiation PAS range was 8–15 (mean 12.1, SD 1.6); BiPAP ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10175617/

Noninvasive positive-pressure ventilation for children with ... NPPV in children with acute asthma is associated with improved gas exchange, decreased respiratory rates, a lower symptom score, and a shorter hospital stay.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5253518/

Paediatric ED BiPAP continuous quality improvement ... With the optimal BiPAP settings (increasing IPAP, lower EPAP and longer I:E ratio) there were significant improvements in their Pediatric Asthma ...

4. journals.sagepub.com journals.sagepub.com/doi/10.4187/respcare.11502?int.sj-abstract.similar-articles.4

Noninvasive Respiratory Support for Pediatric Critical Asthma In this multi-center cohort study, we observed that children with critical asthma are increasingly exposed to HFNC compared with BPAP and CPAP. Rates of HFNC ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02347462

Bilevel Positive Airway Pressure (BiPAP) for the Treatment ... The investigators hypothesize that the use of BiPAP in children with moderate to severe asthma exacerbations could reduce the length of hospital stay, need for ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0929664619307193

Bilevel Positive Airway Pressure ventilation efficiently ... Taken together, BiPAP ventilation is safe and efficient for relief of respiratory symptoms in children with severe asthma attack. Declaration of Competing ...

7. journals.sagepub.com journals.sagepub.com/doi/10.4187/respcare.11502?int.sj-full-text.similar-articles.2

Noninvasive Respiratory Support for Pediatric Critical Asthma In this multi-center cohort study, we observed that children with critical asthma are increasingly exposed to HFNC compared with BPAP and CPAP. Rates of HFNC ...

8. adc.bmj.com adc.bmj.com/content/99/Suppl_2/A251.1

PS-385a Clinical Outcomes After Bilevel Positive Airway ... Conclusions BiPAP treatment for paediatric patients with asthma exacerbations not meeting respiratory failure guidelines may be associated with greater resource ...