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
Study Type
OBSERVATIONAL
Enrollment
310
Children's Hospital Colorado: Allergy Program
Aurora, Colorado, United States
RECRUITINGChildren's National Medical Center: Children's Research Institute
Washington D.C., District of Columbia, United States
RECRUITINGAnn & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology
Chicago, Illinois, United States
NOT_YET_RECRUITINGBoston University School of Medicine: Pulmonary Center
Boston, Massachusetts, United States
RECRUITINGBoston Children's Hospital: Department of Immunology
Boston, Massachusetts, United States
NOT_YET_RECRUITINGIcahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute
New York, New York, United States
NOT_YET_RECRUITINGColumbia University Medical Center: Division of Pediatric Pulmonology
New York, New York, United States
NOT_YET_RECRUITINGCincinnati Children's Hospital Medical Center: Asthma Center
Cincinnati, Ohio, United States
NOT_YET_RECRUITINGAsthma disease activity measured by the number of exacerbations during the 12-month observation period
Time frame: Month 0 to Month 12
Childhood Asthma Severity Index (CASI)
measured on a scale from 0 to 20 with smaller scores indicate a better outcome.
Time frame: Month 0 to Month 12
Modified Rhinitis Symptom Utility Index (MRSUI)
measured by assessing the frequency and severity (degree of bothering: not bothered, somewhat bothered, bothered a lot) of the participant's (1) stuffy or blocked nose, (2) runny nose, (3) sneezing, (4) itchy, watery eyes, and (5) itchy nose or throat over the preceding 14-day period
Time frame: Month 0 to Month 12
Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K)
measured on a scale from 0 to 42 with higher scores indicating a worse outcome (high symptoms and high functional impairment)
Time frame: Month 0 to Month 12
Quality of life measured by the pediatric patient-reported (ages 8-17) or proxy-reported (ages 6-7) Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Short Forms
The outcome measure is a score on a scale from 8 - 40 with higher scores indicating a worse outcome (more severe asthma symptoms).
Time frame: Month 0 to Month 12
Post-bronchodilator forced expiratory volume in 1 second (FEV1) for asthma group
Time frame: Month 3 to Month 12
Post-bronchodilator forced expiratory volume in 1 second (FEV1) for non-asthma group
Time frame: At Month 0
Post-bronchodilator forced vital capacity (FVC) for asthma group
Time frame: Month 3 to Month 12
Post-bronchodilator forced vital capacity (FVC) for non-asthma group
Time frame: At Month 0
Bronchodilator reversibility asthma group in the asthma group, measured by the percent change in FEV1 with albuterol
Time frame: Month 3 to Month 12
Bronchodilator reversibility in the non-asthma group, measured by the percent change in FEV1 with albuterol
Time frame: At Month 0
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