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NCT05210361Active, not recruiting

Critical Windows in the Development of Asthma Endotypes and Phenotypes in High-Risk Toddlers

Source: ClinicalTrials.gov · Last updated 20 Nov 2025

Brief summary (registry, in English)

The purpose of this study is to learn more about how asthma develops in early childhood. This will help doctors understand how to prevent and treat asthma better.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
192 (actual)
First submitted
10 Jan 2022
Start date
14 Feb 2022
Primary completion date
Jul 2027
Lead sponsor
University of Colorado, Denver
Diseases
Asthma
NCT number
NCT05210361

What you commit to

  • Study type: Observational
  • Participants enrolled: 192
  • From 14 Feb 2022 to the primary completion date, Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Wheeze attributed to alternative diagnoses other than bronchiolitis or asthma, including congenital anatomical abnormalities, foreign body aspiration, chronic lung disease of prematurity, other chronic lung disorders such as cystic fibrosis, and cardiac, immune, and gastrointestinal disorders.

Age

  • Gestational age \< 32 weeks.

Who the study is looking for

  • Age 18 months to 36 months at first research encounter
  • For enrollment in Emergency Department (ED)/Inpatient Visit: Presentation to the ED/Inpatient with an acute wheezing episode AND either evidence of at least one prior wheezing episode documented in the electronic medical record (i.e., wheezing, pneumonitis, bronchiolitis, reactive airways disease, or asthma) that occurred ≥ 14 days from current episode, or caregiver report of one of the following:
    • Child has had wheezing or whistling in the chest at any time in the past lasting at least 24 hours and occurring at least 14 days prior to the current ED visit
    • Child has been treated with albuterol or used an inhaler or a nebulizer at least 14 days prior to the current ED visit
    • Caregiver has been told that their child has bronchiolitis, asthma, or reactive airways disease at least 14 days prior to the current ED visit
  • For enrollment in Visit 1: At least three separate wheezing episodes, separated by at least 14 consecutive days without a wheezing episode (wheezing lasting ≥ 24 hours), as reported by parent/caregiver or patient's care provider and/or documented in the patient's medical record
    • Third episode may be at time of presentation to ED or admission as inpatient (IP) to hospital when recruitment would occur (Visit ED/IP)
    • Bronchiolitis and wheezing/asthma exacerbations are considered wheezing episodes
    • The wheezing episode does not require treatment with bronchodilators
  • Live within a US Office of Management and Budget-defined Metropolitan Statistical Area (MSA) and meet at least one of these criteria:
    • Have publicly funded health insurance AND/OR
    • Live in a census tract within an MSA where ≥10% of families have income below the poverty level

Age in the registry: 18 months to 36 months · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Hospital Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.