Longitudinal study of asthma in urban children and adolescents

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

This study is following urban kids and teens with and without asthma for a year to see how asthma affects their symptoms and daily life.

Quick facts

• Study type: Observational
• Enrollment: 310 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Drugs / interventions: immunotherapy
• Locations: 8 sites (Aurora, Colorado and 7 other locations)
• Trial ID: NCT06136091 on ClinicalTrials.gov

What this trial studies

This observational study follows 250 urban children and adolescents with asthma and 60 without asthma over a one-year period. Participants aged 6-17 will be monitored for their asthma symptoms and cold symptoms, with scheduled visits throughout the year. The study aims to establish phenotypic characteristics and gather data on the impact of asthma and respiratory symptoms in this population. Participants with asthma must be on daily controller therapy, while those without asthma must not have used asthma medications in the past year.

Who should consider this trial

Good fit: Ideal candidates are urban children and adolescents aged 6-17 with a diagnosis of asthma requiring daily controller therapy or those without asthma who meet specific criteria.

Not a fit: Patients who do not meet the age or residency requirements, or those who have used asthma medications in the past year, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of asthma in children and lead to improved management strategies.

How similar studies have performed: Other studies have shown success in understanding asthma phenotypes in children, making this approach both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria:

1. Participant and/or parent guardian must be able to understand and provide informed consent and assent
2. 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)

   a. Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion
3. Either:

   1. 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
   2. No report of ever being diagnosed with asthma (non-asthma group)
4. Either:

   1. Require at least Step 2 therapy at the Screening/Enrollment Visit (asthma group), or
   2. Have not used any asthma medications in the prior year (non-asthma group)
5. Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to enrollment
6. Have documentation of current medical insurance with prescription coverage at the Screening/Enrollment Visit
7. Participant and/or parent guardian has a smartphone compatible with the study electronic Patient Reported Outcomes (ePRO) system, Medidata Patient Cloud, and is willing to download one application for study use

Exclusion Criteria:

1. Parent or guardian is not able or willing to give written informed consent or comply with study protocol
2. Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study
3. Are currently receiving immunotherapy
4. Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to enrollment
5. 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
6. 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)
7. Have a known, pre-existing clinically important lung condition other than asthma.
8. Have a current malignancy or previous history of cancer in remission for less than 12 months prior to enrollment
9. Have a known immunodeficiency disease
10. Use of investigational drugs within 4 weeks of enrollment
11. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
12. If in the asthma group, will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow Protocol CAUSE-03 CHEETAH
13. If in the non-asthma group, having bronchodilator reversibility (improvement in Forced expiratory volume in 1 second (FEV1) with albuterol \> = 10%) at the Screening/Enrollment visit
14. Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure. Potential participants may be reassessed as outlined in the Protocol CAUSE-03 Manual of Procedures (MOP)

Where this trial is running

Aurora, Colorado and 7 other locations

• Children's Hospital Colorado: Allergy Program — Aurora, Colorado, United States (Recruiting)
• Children's National Medical Center: Children's Research Institute — Washington D.C., District of Columbia, United States (Recruiting)
• Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology — Chicago, Illinois, United States (Not_yet_recruiting)
• Boston University School of Medicine: Pulmonary Center — Boston, Massachusetts, United States (Recruiting)
• Boston Children's Hospital: Department of Immunology — Boston, Massachusetts, United States (Not_yet_recruiting)
• Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute — New York, New York, United States (Not_yet_recruiting)
• Columbia University Medical Center: Division of Pediatric Pulmonology — New York, New York, United States (Not_yet_recruiting)
• Cincinnati Children's Hospital Medical Center: Asthma Center — Cincinnati, Ohio, United States (Not_yet_recruiting)

Conditions Asthma; Observational study; Children