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Recruiting
NCT06136091
Protocol CAUSE-03 / CHEETAH
Conditions: Asthma
Sex: All
Ages: 6 Years – 17 Years
Healthy volunteers: Yes
Enrollment: 310
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Location: Children's Hospital Colorado: Allergy Program Aurora Colorado
Summary
This is a one-year longitudinal, observational study of 250 urban children and adolescents with asthma and 60 without asthma, ages 6-17 years old.
Participants with asthma will require daily controller therapy with inhaled corticosteroids ICS (at least Step 2 therapy). Those without asthma cannot have used asthma medications in the year prior to enrollment and cannot demonstrate bronchodilator reversibility at baseline. Phenotypic characteristics will be established at baseline, and the participants will be seen at scheduled visits over 12 months. Each participant will be asked to monitor and self-report cold symptoms and will be asked to complete up to three cold visits
Eligibility Criteria
Inclusion Criteria:
1. Participant and/or parent guardian must be able to understand and provide informed consent and assent
2. Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE-03 Manual of Operations (MOP)
a. Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion
3. Either:
1. Have had a diagnosis of asthma made \> 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician \
Source: ClinicalTrials.gov (NCT06136091). StuddyBuddy aggregates publicly available trial information.