Recruiting PHASE3 Bronchiolitis

New treatment option for Bronchiolitis

Official title Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features

ClinicalTrials.gov ID: NCT06946264

What this study is testing

What is Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution?

Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for bronchiolitis.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Bronchiolitis is the leading cause of pediatric morbidity and healthcare costs. Despite the commonplace use of bronchodilator treatments, like albuterol, in conditions like asthma, their efficacy in bronchiolitis remains controversial due to the heterogeneity in patient response.
  • Phase 3: a large, late-stage study
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 3 to 24

You may be able to join if

  • Children between 3 to 24 months of age
  • Clinical diagnosis of bronchiolitis by the treating provider(s), defined by the American Academy of Pediatrics as a clinical syndrome involving lower...
  • Children who either have no history of prematurity or have a history of prematurity but without associated co-morbidities
  • Emergency department (ED) visit to seek care at Nemours Children's Health-Florida (NCH-FL)

You likely can't join if

  • Patients previously enrolled in the PI's K12 study
  • Documented history of asthma or reactive airway disease
  • Co-morbidities affecting airway response (e.g., chronic lung disease, bronchopulmonary dysplasia, bronchiectasis, congenital heart disease...
  • Diagnosis of pneumonia by chest radiography
  • Inhaled, nebulized, or oral corticosteroid use within 72 hours of ED evaluation
  • Inhaled, nebulized, or oral bronchodilator administration within 4 hours of ED arrival

The study team makes the final eligibility decision.

Where it's taking place

  • Orlando, Florida, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 3 months to 24 months. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Orlando, Florida, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.