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Registry for Asthma Characterization and Recruitment 2 (RACR2)

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ClinicalTrials.gov Identifier: NCT02513264
Recruitment Status : Recruiting
First Posted : July 31, 2015
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
Inner-City Asthma Consortium
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease
Asthma

Detailed Description:

The overall goal of the Registry for Asthma Characterization and Recruitment 2 (RACR2) is to create a database of participants who are potentially eligible for future Inner City Asthma Consortium (ICAC) clinical research studies. The registry will provide an avenue to assess various asthma and allergy characteristics, which will result in more efficient recruitment for current and future ICAC protocols.

Potential participants will be recruited via telephone or in person. Those deemed potentially eligible for a current protocol or protocol in development may be invited to the clinic for further data collection and assessments. This registry allows flexibility in selecting the eligibility criteria and data collection to match planned or upcoming ICAC protocols. At each stage of data collection, participants may be discontinued, put on hold, or invited to participate in further screening activities, depending on the likelihood that they will qualify for a future protocol. Participants may opt to withdraw their information or discontinue from the registry at any time, in person, by telephone, or in writing.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Years
Official Title: Registry for Asthma Characterization and Recruitment 2 (ICAC-25)
Study Start Date : June 2015
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma




Primary Outcome Measures :
  1. Number of participants with asthma and allergy characteristics [ Time Frame: Year 7 ]
    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).


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

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.

  1. All participants must resides within the metropolitan statistical area that includes the clinical site.
  2. 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
  3. Participants without asthma, atopy, and rhinitis must meet all of the following:

    • Negative history of an asthma diagnosis by a clinician
    • Negative history of a diagnosis of atopic dermatitis or eczema by a clinician
    • Negative history of a rhinitis diagnosis by a clinician
    • A forced expiratory volume at 1 second (FEV1) >= 5% predicted
    • Negative prick skin-tests to any of a panel of indoor and outdoor allergens
    • No current asthma as determined by the appropriate case report form
    • No current chronic rhinitis/sinusitis as determined by the appropriate case report form

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from enrollment:

  1. 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
  2. Does not primarily speak English (or Spanish at clinical sites with Spanish-speaking staff)
  3. 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)
  4. Is a foster child (not applicable if participant is able to provide consent)
  5. 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
  6. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513264


Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Pascuala Pinedo-Estrada    720-777-8077    pascuala.pinedo-estrada@childrenscolorado.org   
Principal Investigator: Andrew Liu, MD         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Alicia Newcomer    202-476-4698    anewcome@childrensnational.org   
Principal Investigator: Stephen Teach, MD, MPH         
United States, Illinois
Ann and Robert Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Sarah Godley    312-227-6454    sgodley@luriechildrens.org   
Principal Investigator: Jacqueline Pongracic, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Michele Cootauco    410-614-5467    mcootau1@jhu.edu   
Principal Investigator: Robert A Wood, MD         
United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Lisa Gagalis    617-414-3263    lmccay@bu.edu   
Principal Investigator: George O'Connor, MD, MS         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Sherae Hereford    313-916-6954    sherefo3@hfhs.org   
Principal Investigator: Edward Zoratti, MD         
United States, Missouri
St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Beth Tesson    314-286-1290    Tesson_B@kids.wustl.edu   
Principal Investigator: Leonard Bacharier, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Marcela Pierce    212-305-6255    mp2648@cumc.columbia.edu   
Principal Investigator: Meyer Kattan, MD         
United States, Ohio
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 452229
Contact: Kristi Curtsinger    513-803-1651    kristi.curtsinger@cchmc.org   
Principal Investigator: Carolyn Kercsmar, MD         
Principal Investigator: Gurjit Hershey, MD, PhD         
United States, Texas
University of Texas Southwestern Medical School Recruiting
Dallas, Texas, United States, 75390
Contact: Dolores Santoyo    214-648-2620    dolores.santoyo@utsouthwestern.edu   
Principal Investigator: Rebecca Gruchalla, MD         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Inner-City Asthma Consortium
Investigators
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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

Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02513264     History of Changes
Other Study ID Numbers: DAIT ICAC-25
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Registry
Asthma
Inner City Asthma Consortium (ICAC) study eligibility
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases