Asthma Clinical Trial
— RACR3Official title:
Registry of Asthma Characterization and Recruitment 3 (RACR3) (CAUSE-02)
NCT number | NCT05272241 |
Other study ID # | DAIT CAUSE-02 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 15, 2022 |
Est. completion date | May 2028 |
This is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future DAIT NIAID-sponsored Childhood Asthma in Urban Settings (CAUSE) studies.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | May 2028 |
Est. primary completion date | May 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado: Allergy Program | Aurora | Colorado |
United States | Boston Children's Hospital: Department of Immunology | Boston | Massachusetts |
United States | Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center: Asthma Center | Cincinnati | Ohio |
United States | Columbia University Medical Center: Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine | New York | New York |
United States | Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute | New York | New York |
United States | Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research Site | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with asthma and allergy characteristics | Characteristics of the participants enrolled in the registry will be assessed on a periodic basis (descriptive summary of diagnosis and parameters associated with the former). | 7 years |
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