Registry for asthma characterization and recruitment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, non-interventional registry aimed at creating and maintaining a database of participants for current and future studies on childhood asthma in urban settings. Approximately 1,500 participants of all ages will be enrolled from selected metropolitan areas. The registry will gather data during a core visit and may include optional follow-up visits, assessing various asthma and allergy characteristics. Healthy controls may also be invited to participate for validation and training purposes, ensuring a comprehensive approach to participant recruitment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant is either:

   1. At least 18 years old, willing and able to provide informed consent at the time of enrollment
   2. Under the age of 18, accompanied by a legal guardian who is willing and able to provide informed consent at the time of enrollment
2. Participant has a primary place of residence within the Office of Management and Budget (OMB)-defined Metropolitan Statistical Area (MSA)

Exclusion Criteria:

1. Participant does not speak English or Spanish and/or guardian does not speak English or Spanish
2. Participant does not have access to a phone, either personal or public, with regularity that could be used for scheduling and safety follow-up
3. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the 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 affect the quality or interpretation of the data obtained from the study

Participants who are pregnant or lactating will not be excluded or discontinued from the study, but will not undergo any procedures that are prohibited during pregnancy per the Childhood Asthma in Urban Settings 02 (CAUSE-02) Registry for Asthma Characterization and Recruitment 3 (RACR3) Manual of Procedures (MOP)(e.g., allergen skin testing, spirometry) during the pregnancy.

Potential participants may be reassessed as outlined in the Protocol CAUSE-02 MOP.

Where it's running

• Children's Hospital Colorado: Allergy Program
  Aurora, Colorado, United States Recruiting
• Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research Site
  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 Recruiting
• Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute
  New York, New York, United States Recruiting
• Cincinnati Children's Hospital Medical Center: Asthma Center
  Cincinnati, Ohio, United States Recruiting
• Boston Children's Hospital: Department of Immunology
  Boston, Massachusetts, United States Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.