Asthma in ChildrenWINDOWSNCT05210361
Critical Windows in the Development of Asthma Endotypes and Phenotypes in High-Risk Toddlers
An observational study of Asthma in Children and Wheezing, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 36 months
- Conditions the study is for
- Asthma in Children, Wheezing
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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
- Medical subject headings
- Respiratory Sounds
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At visit 5, after 4 years of participation in the longitudinal study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start14 Feb 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew H Liu, MD, Principal investigator, University of Colorado, DenverKatharine Hamlington Smith, PhD, Study director, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210361
- Sponsor's protocol ID
- 21-3116
- Other IDs
- U01AI160033
- Acronym
- WINDOWS
- Status last verified
- Nov 2025
- First submitted
- 10 Jan 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Windows in the Development of Asthma Endotypes and Phenotypes in High-Risk Toddlers
- ClinicalTrials.gov ID
- NCT05210361
- Acronym / sponsor ID
- WINDOWS / 21-3116
- Conditions
- Asthma in Children, Wheezing
- Keywords
- childhood asthma, recurrent wheeze, asthma phenotypes, asthma endotypes, asthma development
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (12 listed)
- 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:
- 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
- Live within a US Office of Management and Budget-defined Metropolitan Statistical Area (MSA) and meet at least one of these criteria:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew H Liu, MD principal investigator
University of Colorado, Denver
Katharine Hamlington Smith, PhD study director
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children and Wheezing, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of persistent asthma (time frame: At visit 5, after 4 years of participation in the longitudinal study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.