Actively Recruiting
Protocol CAUSE-03 / CHEETAH
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2025-05-14
310
Participants Needed
8
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Protocol CAUSE-03 / CHEETAH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant and/or parent guardian must be able to understand and provide informed consent and assent
- Have a primary residence in one of the pre-selected recruitment census tracts or live in the Metropolitan Statistical Area with publicly funded health insurance
- Have had an asthma diagnosis more than 1 year before recruitment or have respiratory symptoms for more than 1 year if diagnosed within the last year (asthma group), or no history of asthma diagnosis (non-asthma group)
- Require at least Step 2 therapy at screening/enrollment (asthma group), or have not used asthma medications in the prior year (non-asthma group)
- Able to perform acceptable and repeatable spirometry according to American Thoracic Society criteria
- Have current medical insurance with prescription coverage at screening/enrollment
- Participant and/or parent guardian has a compatible smartphone and is willing to download the study app
You will not qualify if you...
- Parent or guardian unable or unwilling to give informed consent or comply with the study
- Have medical problems requiring systemic corticosteroids or immunomodulators during the study
- Currently receiving immunotherapy or biologic therapy within 3 months prior to enrollment
- Require more than fluticasone 500 mcg twice daily plus LABA and/or LAMA or use oral corticosteroids daily or every other day for more than 14 days at screening
- Currently pregnant, lactating, or planning pregnancy during the study; females of child-bearing potential must use acceptable birth control
- Have a known clinically important lung condition other than asthma
- Have current malignancy or cancer remission less than 12 months prior
- Have known immunodeficiency disease
- Use investigational drugs within 4 weeks before enrollment
- Have medical problems that increase risk or interfere with study compliance or data quality
- Asthma group participants unwilling to allow study clinician to manage asthma or follow study medication protocol
- Non-asthma group participants with bronchodilator reversibility (FEV1 improvement ≥10%) at screening
- History of life-threatening asthma exacerbation in past 2 years requiring intubation or mechanical ventilation or causing hypoxic seizure
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Children's Hospital Colorado: Allergy Program
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Children's National Medical Center: Children's Research Institute
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology
Chicago, Illinois, United States, 60611
Not Yet Recruiting
4
Boston University School of Medicine: Pulmonary Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
5
Boston Children's Hospital: Department of Immunology
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
6
Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute
New York, New York, United States, 10029
Not Yet Recruiting
7
Columbia University Medical Center: Division of Pediatric Pulmonology
New York, New York, United States, 10032
Not Yet Recruiting
8
Cincinnati Children's Hospital Medical Center: Asthma Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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