RecruitingNCT06136091

Protocol CAUSE-03 / CHEETAH

Mechanisms Underlying Asthma Symptoms and Exacerbations Examined Across T2 Status in Children (CHEETAH) (CAUSE-03)


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

310 participants

Start Date

Apr 23, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study (CAUSE-03/CHEETAH) examines asthma management in children and adults living in specific neighborhoods (selected census tracts) and tests whether a structured asthma care program improves outcomes compared to standard care. It also recruits people without asthma for comparison. The study aims to reduce asthma-related disparities in communities with higher pollution or poverty. **You may be eligible if...** - You live in one of the designated neighborhoods or within the metropolitan area with public health insurance - You have a confirmed asthma diagnosis for more than 1 year (or respiratory symptoms for more than 1 year) - You require at least a basic level of asthma treatment (Step 2 or above) - Or, you have never been diagnosed with asthma and haven't used asthma medication in the past year (for the comparison group) - You are able to do breathing tests (spirometry) **You may NOT be eligible if...** - You are currently pregnant or breastfeeding - You have another significant lung disease - You are currently receiving immunotherapy or biologic asthma medications - You have had a life-threatening asthma attack requiring a breathing machine in the past 2 years - You have a known immune deficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(8)

Children's Hospital Colorado: Allergy Program

Aurora, Colorado, United States

Children's National Medical Center: Children's Research Institute

Washington D.C., District of Columbia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology

Chicago, Illinois, United States

Boston University School of Medicine: Pulmonary Center

Boston, Massachusetts, United States

Boston Children's Hospital: Department of Immunology

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute

New York, New York, United States

Columbia University Medical Center: Division of Pediatric Pulmonology

New York, New York, United States

Cincinnati Children's Hospital Medical Center: Asthma Center

Cincinnati, Ohio, United States

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NCT06136091


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