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
Who can participate
Age range6 Years – 17 Years
SexALL
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Inclusion criteria
✓. 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)
✓. Either:
✓. 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)
✓. Either:
✓. Require at least Step 2 therapy at the Screening/Enrollment Visit (asthma group), or
✓. Have not used any asthma medications in the prior year (non-asthma group)
Exclusion criteria
✕. Parent or guardian is not able or willing to give written informed consent or comply with study protocol
What they're measuring
1
Asthma disease activity measured by the number of exacerbations during the 12-month observation period
Timeframe: Month 0 to Month 12
Trial details
NCT IDNCT06136091
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. 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
✕. Are currently requiring greater than fluticasone 500 mcg bid plus Long-Acting Beta Agonists (LABA) one puff twice daily or its equivalent plus Long Acting Muscarinic Antagonists (LAMA) and/or individuals using oral corticosteroids daily or every other day for more than 14 days at the time of the Screening/Enrollment Visit
✕. Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (i.e., oral subcutaneous, mechanical, or surgical contraception)
✕. Have a known, pre-existing clinically important lung condition other than asthma.
✕. Have a current malignancy or previous history of cancer in remission for less than 12 months prior to enrollment