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

Asthma in Children Clinical Trial

— WINDOWS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05210361
• Other study ID #: 21-3116
• Secondary ID: U01AI160033
• Status: Active, not recruiting
• Start date: February 14, 2022
• Est. completion date: July 2027

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 192
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Respiratory Sounds
• Wheezing

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of persistent asthma	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.	At visit 5, after 4 years of participation in the longitudinal study