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

NCT05210361 | Active Not Recruiting

• 2 other identifiers: 21-3116U01AI160033
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children; Wheezing

Keywords

childhood asthma; recurrent wheeze; asthma phenotypes; asthma endotypes; asthma development

Outcome Measures

Primary Outcomes (1)

• Diagnosis of persistent asthma

  Children 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.

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

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of toddlers at high risk for developing childhood asthma, living in low-income urban communities in the Denver Metropolitan Area in Colorado.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew H Liu, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Katharine Hamlington Smith, PhD

  University of Colorado, Denver

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 27, 2022
• Study Start: February 14, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

US (1)