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RecruitingNCT05272241RACR3Updated Aug 21, 2026

Registry of Asthma Characterization and Recruitment 3 (RACR3)

An observational study in Asthma, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 7 sites in United States. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

From the registry’s dates

  • Started May 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma

Keywords

  • Asthma
  • Allergy
  • CAUSE
  • RACR
03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 158 across 1,250 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant is either:

    1. At least 18 years old, willing and able to provide 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

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
7 Years
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

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).

    Time frame: 7 years

07

Study locations

5 of 7 sites recruiting
  • 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
    • · Contact617-919-1301
    • Wanda Phipatanakul · Principal investigator
  • 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
    • · Contact212-305-6270
  • Cincinnati Children's Hospital Medical Center: Asthma Center
    Cincinnati, Ohio 45229, United States
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05272241
Responsible party
Sponsor
First posted
Mar 9, 2022
Start date
May 6, 2022
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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