AsthmaRACR3NCT05272241
Registry of Asthma Characterization and Recruitment 3 (RACR3)
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
Trial 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 more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 1,500 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 May 2022to May 2027
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Children's Hospital Colorado: Allergy Program
Aurora, Colorado, 80045
Pascuala Pinedo-Estrada, 720-777-8077, pascuala.pinedo-estrada@childrenscolorado.org
Andrew Liu, MD
- Not yet recruiting
Boston Children's Hospital: Department of Immunology
Boston, Massachusetts, 02215
617-919-1301
Wanda Phipatanakul
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology
Chicago, Illinois, 60611
Sarah Godley, 312-227-6451, sgodley@luriechildrens.org
Rajesh Kumar, MD
- Recruiting
Cincinnati Children's Hospital Medical Center: Asthma Center
Cincinnati, Ohio, 45229
Katy Geil, 513-803-5178, kathryn.geil@cchmc.org
Neeru Hershey, MD
- Recruiting
Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute
New York, New York, 10029
Catherine Swarts, 212-824-7982, catherine.swarts@icahn.mssn.edu
Paula Busse, MD
- Not yet recruiting
Columbia University Medical Center: Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine
New York, New York, 10032
212-305-6270
- Recruiting
Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research Site
Washington D.C., District of Columbia, 20010
Alicia Mathis, 202-476-5134, anewcome@childrensnational.org
Stephen Teach, MD
About this study
Official title: Registry of Asthma Characterization and Recruitment 3 (RACR3) (CAUSE-02)
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.
- Conditions
- Asthma
- Keywords
- Asthma, Allergy, CAUSE, RACR
- Medical subject headings
- Asthma, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start6 May 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christine A. Sorkness, RPh, PharmD, Study chair, University of Wisconsin School of Medicine and Public Health; Division of Allergy & ImmunologyDaniel J. Jackson, MD, Study chair, University of Wisconsin School of Medicine and Public Health; Division of Allergy & Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272241
- Sponsor's protocol ID
- DAIT CAUSE-02
- Acronym
- RACR3
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Asthma Characterization and Recruitment 3 (RACR3) (CAUSE-02)
- ClinicalTrials.gov ID
- NCT05272241
- Acronym / sponsor ID
- RACR3 / DAIT CAUSE-02
- Conditions
- Asthma
- Keywords
- Asthma, Allergy, CAUSE, RACR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 6 May 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Participant is either:
- Participant has a primary place of residence within the Office of Management and Budget (OMB)-defined Metropolitan Statistical Area (MSA)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with asthma and allergy characteristics
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Children's Hospital Colorado: Allergy Program
Aurora, United States
Children's National Medical Center: Inner City Asthma Consortium (ICAC) Clinical Research Site
Washington D.C., United States
Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology
Chicago, United States
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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with asthma and allergy characteristics (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.