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Corticosteroid

Epinephrine + Dexamethasone for Bronchiolitis (BIPED Trial)

Phase 3

Recruiting

Led By Amy Plint, MSc, MD

Research Sponsored by Children's Hospital of Eastern Ontario

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presenting to the ED with an episode of bronchiolitis defined as an episode of wheezing or crackles in a child < 12 month of age associated with signs of an upper respiratory tract infection during peak season for RSV bronchiolitis

Age 60 days to less than 12 months

Must not have

Severe respiratory distress evidenced by specific vital sign criteria or requiring resuscitation room care

Presenting with symptoms of apnea prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 years of age

Awards & highlights

Pivotal Trial

Summary

This trial will test whether inhaling epinephrine and taking a 2-day course of dexamethasone reduces the number of hospitalizations for bronchiolitis in infants.

Who is the study for?

This trial is for infants under 12 months old who are experiencing their first episode of bronchiolitis, with symptoms like wheezing or crackles alongside an upper respiratory infection. They must not have severe respiratory distress, known chronic diseases affecting the heart/lungs, recent steroid treatment, a history of adverse reactions to steroids, prior beta-agonist treatment in the ED before enrollment, exposure to chickenpox without immunity, significant prematurity (<37 weeks and <60 days corrected age), or any barriers to follow-up.

What is being tested?

The study tests if inhaling epinephrine and taking oral dexamethasone reduces hospital admissions within 7 days compared to a placebo. It's a phase III trial where infants at twelve EDs will be randomly assigned double-blindly into two groups: one receiving actual treatments and the other getting placebos (fake treatments).

What are the potential side effects?

Possible side effects from epinephrine may include rapid heartbeat and shakiness; dexamethasone could cause irritability or increased appetite. Placebo treatments should not cause any direct side effects but won't provide active relief from symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child under 1 year has wheezing or crackles and signs of a cold during RSV season.

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I am between 2 months and less than 1 year old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe breathing problems needing emergency care.

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I have experienced symptoms of apnea before joining this study.

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I have not taken any corticosteroids in the past week.

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I have received beta-agonist treatment in the emergency department before joining this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 years of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 years of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 years of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Admission to hospital for bronchiolitis within 7 days post enrollment

Secondary study objectives

Admission to hospital for bronchiolitis at the time of the enrollment ED visit

All cause Health care provider visits (including ED visits) by day 21 following enrollment ED

All cause admission to Hospital within 21 days following enrollment ED visit

+1 more

Other study objectives

Exploratory Outcome 10: Health care utilization (including ambulatory visits, ED visits, hospitalization) for respiratory illness

Exploratory Outcome 11: Development of respiratory illnesses

Exploratory Outcome 1: Admission to hospital for bronchiolitis within 21 days following enrollment ED visit

+12 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Intervention ArmExperimental Treatment3 Interventions

Oral dexamethasone and nebulized epinephrine OR Oral dexamethasone and inhaled epinephrine given by MDI

Group II: Control ArmPlacebo Group3 Interventions

Oral placebo (OraBlendTM in Canada and a compounded oral placebo solution at New Zealand/Australia sites) and nebulized saline. OR Oral placebo (OraBlendTM in Canada and a compounded oral placebo solution at New Zealand/Australia sites) and inhaled placebo given by MDI.

0 / 6Eligibility criteria met