Registry of Asthma Characterization and Recruitment 3 (RACR3)

NCT05272241 | Recruiting

• 1 other identifier: DAIT CAUSE-02
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 7

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.

Conditions

Asthma

Keywords

Asthma; Allergy; CAUSE; RACR

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population enrolled in this registry will be participants living within the Metropolitan Statistical Area (MSA) assigned by the Office of Management and Budget (OMB) for a given clinical site. The Protocol Childhood Asthma in Urban Settings 02 (CAUSE-02) Registry for Asthma Characterization and Recruitment 3 (RACR3) eligibility criteria are broad to anticipate diverse recruitment needs for current and future CAUSE protocols.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (7)

Children's Hospital Colorado: Allergy Program

Aurora, Colorado, 80045, United States

RECRUITING

Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research Site

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology

Chicago, Illinois, 60611, United States

RECRUITING

Boston Children's Hospital: Department of Immunology

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute

New York, New York, 10029, United States

RECRUITING

Columbia University Medical Center: Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine

New York, New York, 10032, United States

NOT YET RECRUITING

Cincinnati Children's Hospital Medical Center: Asthma Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood Serum

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: April 15, 2022
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)