Registry for Asthma Characterization and Recruitment 2
RACR2
1 other identifier
observational
1,384
1 country
10
Brief Summary
There is a need for people to take part in research studies to learn more about diseases and how to treat them. The Registry for Asthma Characterization and Recruitment 2 (RACR2) will create a database of participants with asthma and nasal allergies, or risk factors for these conditions, who are potentially eligible for future Inner City Asthma Consortium (ICAC) trials. The registry database will include assessments of various asthma and allergy characteristics to achieve a more efficient, selective recruitment of these participants for other protocols.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2015
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 14, 2015
CompletedFirst Submitted
Initial submission to the registry
July 23, 2015
CompletedFirst Posted
Study publicly available on registry
July 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2020
CompletedJanuary 25, 2021
January 1, 2021
4.9 years
July 23, 2015
January 22, 2021
Conditions
Keywords
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).
Year 7
Eligibility Criteria
Subjects who reside within the metropolitan statistical area of the clinical site and have clinician-diagnosed asthma, current symptoms of asthma, or risk factors for development of asthma. The population may at times include participants without asthma, atopy, and rhinitis.
You may qualify if:
- Eligibility criteria vary depending on recruitment needs for future ICAC protocols. Participants with asthma and participants without asthma, atopy, and rhinitis may be recruited at the same time or different times, depending on recruitment needs.
- Certain characteristics or groups of characteristics within each criterion may be selected for periods of time across clinical sites or at each individually participating clinical site. For example, over a 6-month period, the Consortium could decide to recruit children aged 6 through 12 years with diagnosed asthma who have asthma symptoms, have a history of an asthma exacerbation, and reside in prespecified census tracts within the metropolitan statistical area. During selective recruitment periods, individuals who meet broader criteria may or may not be enrolled at the discretion of the Consortium.
- All participants must resides within the metropolitan statistical area that includes the clinical site.
- Participants with asthma are defined by having evidence of asthma. Evidence of asthma is defined by meeting at least one of the following criteria:
- Clinician-diagnosed asthma
- Asthma symptoms, history of an asthma exacerbation, or current use of asthma medication(s)
- Recurrent wheezing
- Wheezing apart from a cold
- At times of selective recruitment, participants with asthma may be required to meet more selective criteria above and may be required to meet one or more of the criteria in risk factors for asthma. Evidence of risk factors for asthma is defined by meeting at least one of the following criteria:
- Parental history of asthma
- Eczema or atopic dermatitis
- Reported allergies to pets, food, indoor allergens, or outdoor allergens
- Allergic sensitization by results of allergy skin testing or results of serum immunoglobulin E (IgE) testing
- Rhinitis
- Participants without asthma, atopy, and rhinitis must meet all of the following:
- +7 more criteria
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from enrollment:
- Has any of the following chronic medical conditions: cardiac condition requiring daily medication, seizure disorder requiring daily medication, obvious severe mental retardation that prevents the participant from answering questions or following instructions, cystic fibrosis, immune deficiency, type 1 diabetes, allergic bronchopulmonary aspergillosis, or any other chronic medical condition at the discretion of the registry clinician
- Does not primarily speak English (or Spanish at clinical sites with Spanish-speaking staff)
- Has a primary caretaker who does not speak English (or Spanish at clinical sites with Spanish-speaking staff; not applicable if participant is able to provide consent)
- Is a foster child (not applicable if participant is able to provide consent)
- Is unwilling to sign the written informed consent form if of age, or parent/legal guardian is unwilling to sign the written informed consent if participant is not of age
- Is unwilling to sign the assent form, if age appropriate
- Participants who are pregnant will not be excluded or discontinued from RACR2 but will not undergo any procedures that are prohibited during pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 452229, United States
University of Texas Southwestern Medical School
Dallas, Texas, 75390, United States
Related Links
Biospecimen
Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacqueline Pongracic, M.D.
Ann & Robert H Lurie Children's Hospital of Chicago
- PRINCIPAL INVESTIGATOR
Edward M. Zoratti, M.D.
Henry Ford Hospital
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
July 23, 2015
First Posted
July 31, 2015
Study Start
April 14, 2015
Primary Completion
March 13, 2020
Study Completion
March 13, 2020
Last Updated
January 25, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share