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OpenTrials
Active, Not Recruiting

NCT Number: NCT05210361

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Gestational age < 32 weeks.

Treatment and study plan

Primary outcomes

  1. Diagnosis of persistent asthma

    Time frame: At visit 5, after 4 years of participation in the longitudinal study

    Children will be classified as having persistent asthma if at least 1 of the following 3 conditions are met:

    • Doctor Diagnosis: a parent-reported physician's diagnosis of asthma between age 4 and 7 years plus asthma symptoms or the use of asthma controller medication for at least 6 of the past 12 months
    • Lung Function: bronchodilator-induced improvement of forced expiratory volume in 1 second (FEV1) by 10% or more plus asthma symptoms or use of asthma controller medication for at least 6 of the past 12 months
    • Symptoms: report in the past 12 months of 2 or more wheezing episodes, 2 or more doctor's office visits for asthma/wheeze, 1 or more hospitalizations for asthma/wheeze, or use of controller medications for at least 6 of the past 12 months.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Acronym: WINDOWS

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2022
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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