Protocol CAUSE-03 / CHEETAH
ConditionAsthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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
Qualifiers
Participant and/or parent guardian must be able to understand and provide informed consent and assent
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)
Have had a diagnosis of asthma made > 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician <= 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment (asthma group), or
No report of ever being diagnosed with asthma (non-asthma group)
Disqualifiers
Parent or guardian is not able or willing to give written informed consent or comply with study protocol
Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study
Are currently receiving immunotherapy
Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to enrollment
Trial design
Treatments tested in this trial
- Not listed
Trial groups
310 Participants
are grouped into 2 trial groupsSponsors and collaborators
Source ClinicalTrials.gov