Registry for Asthma Characterization and Recruitment 2 (RACR2)

Registry for Asthma Characterization and Recruitment 2 (ICAC-25)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1384

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann and Robert Lurie Children's Hospital of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 452229
        • Cincinnati Children's Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Year 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 14, 2015

Primary Completion (Actual)

March 13, 2020

Study Completion (Actual)

March 13, 2020

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

3
Subscribe