Recruiting

Observational Study

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT05272241

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT05272241

Start date

May 6, 2022

Status verified date

Aug, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of participants with asthma and allergy characteristics [ Time Frame: 7 years ]

Central Contacts and Locations

Locations

Children's Hospital Colorado: Allergy Program

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Andrew Liu, MD

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

Recruiting

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

Contacts

Principal Investigator:

Stephen Teach, MD

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Rajesh Kumar, MD

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

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Paula Busse, MD

Cincinnati Children's Hospital Medical Center: Asthma Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Neeru Hershey, MD

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Asthma
  • Allergy
  • CAUSE
  • RACR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-08-21.