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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05210361
Acronym
WINDOWS
Enrollment
192
Registered
2022-01-27
Start date
2022-02-14
Completion date
2027-07-31
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in Children, Wheezing

Keywords

childhood asthma, recurrent wheeze, asthma phenotypes, asthma endotypes, asthma development

Brief summary

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.

Interventions

None listed

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Months to 36 Months
Healthy volunteers
No

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: 1. Have publicly funded health insurance AND/OR 2. 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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of persistent asthmaAt visit 5, after 4 years of participation in the longitudinal studyChildren will be classified as having persistent asthma if at least 1 of the following 3 conditions are met: 1. 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 2. 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 3. 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026