Registry of Asthma Characterization and Recruitment 3 (RACR3)

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT05272241

Collaborator

(none)

1,500

Enrollment

Locations

72.5

Anticipated Duration (Months)

214.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma

Detailed Description

Protocol CAUSE-02 RACR3 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. Approximately 1,500 participants - of all ages, living in selected Office of Management and Budget (OMB) defined Metropolitan Statistical Areas (MSAs) will be enrolled in the registry.

The registry database will be generated with data gathered at a single core visit, followed by optional additional visits. The registry will include assessments of various asthma and allergy characteristics to achieve a more flexible, efficient, selective, and inclusive approach to participant recruitment while still following national guidelines to foster participant safety. CAUSE investigators may invite children or adults without asthma or atopic diseases to participate in the registry as "healthy" controls; for validation of laboratory tests, study monitoring equipment, and/or procedures; or for site procedure training of study personnel for certification and quality assurance.

Participants may opt to withdraw their information or discontinue from the registry at any time, in person, by telephone, or in writing.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Registry of Asthma Characterization and Recruitment 3 (RACR3) (CAUSE-02)

Actual Study Start Date :

Apr 15, 2022

Anticipated Primary Completion Date :

May 1, 2028

Anticipated Study Completion Date :

May 1, 2028

Outcome Measures

Primary Outcome Measures

Number of participants with asthma and allergy characteristics [7 years]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Participant does not speak English or Spanish and/or guardian does not speak English or Spanish
Participant does not have access to a phone, either personal or public, with regularity that could be used for scheduling and safety follow-up
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Colorado: Allergy Program	Aurora	Colorado	United States	80045
2	Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research Site	Washington	District of Columbia	United States	20010
3	Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology	Chicago	Illinois	United States	60611
4	Boston Children's Hospital: Department of Immunology	Boston	Massachusetts	United States	02215
5	Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute	New York	New York	United States	10029
6	Columbia University Medical Center: Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine	New York	New York	United States	10032
7	Cincinnati Children's Hospital Medical Center: Asthma Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: Christine A. Sorkness, RPh, PharmD, University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology
Study Chair: Daniel J. Jackson, MD, University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology