Registry for Asthma Characterization and Recruitment 2

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.

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.