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Protocol Details

New Approaches for Empowering Studies of Asthma in Populations of African Descent

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-HG-0092

Sponsoring Institute

National Human Genome Research Institute (NHGRI)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

White;
Native Hawaiian/Pacific Islander;
Hispanic or Latino;
Asian;
Children;
American Indian or Alaskan Native

Special Instructions

Currently Not Provided

Keywords

Trans-omics

Recruitment Keyword(s)

None

Condition(s)

Asthma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Human Genome Research Institute

Background:

Some groups of people have a high prevalence of asthma and allergic disease. Also, asthma and allergic disease are often found in several members of the same family. Researchers want to learn more about what factors might cause asthma, both genetic and environmental.

Objective:

To build a collection of information to try to find genes that cause conditions and disorders such as asthma and allergic disease.

Eligibility:

People ages 18 99 of self-identified African, African American, or African Caribbean descent who either have no history of asthma or wheeze or have a physician s diagnosis of asthma

Design:

Participants will be screened with an interview by phone or in person.

Participants will fill out a questionnaire about their general health and exposure to allergens and smoke.

Participants will have a physical exam.

Participants will have blood tests.

Participants will provide a skin cell sample. Up to two samples will be taken from the inside of the nose. A brush will be used to take the samples.

Participants will have a breathing test. They will be asked to blow forcefully 3 or more times into a lung function machine.

Participants may have their blood and skin samples sent to a lab. DNA will be extracted from the samples and tested.

Participants blood and skin samples will be stored. Samples may be used in future research studies.

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Eligibility

INCLUSION CRITERIA:

Individuals age 18 to 99 of self-identified African, African American, or African Caribbean ancestry who either have no history of asthma or wheeze (controls) or have a physician s diagnosis of asthma. This study focuses exclusively on African ancestry individuals in order to address a lack in the field of asthma research focusing on those of African ancestry despite the greater disease burden experienced by these individuals. Enrollment for the CAAPA2 study at the NIH CC will include only adults, while children will be enrolled at other CAAPA2 sites, consistent with expertise at those sites.

EXCLUSION CRITERIA:

-First degree relative of enrolled study participant (as determined through responses to a screening questionnaire to question on participation of parents, siblings, or half-siblings)

-Current and active smoker

-History of: chronic obstructive pulmonary disease, chronic obstructive airway disease, emphysema, chronic bronchitis, lung transplant, kyphoscoliosis, sarcoidosis, bronchopulmonary dysplasia, cystic fibrosis, bronchiectasis, rheumatoid arthritis, Crohn s disease, psoriasis, carcinoma of the lung, ciliary dyskinesia, lupus, or active tuberculosis

-Having any medical illnesses that would increase the risk that the participant would incur by participating in the study, interfere with the outcomes of the study, or interfere with the study procedures (evaluated using Spirometry Screener.)

-Current or previous COVID-19 infection

-Pregnant women: while study procedures are all minimal risk, the inclusion of pregnant women is not necessary to address the research questions. Additionally, pregnancy may affect some of our parameters of interest (particularly gene expression) in unpredictable ways and the size of the growing fetus may introduce mechanical challenges to optimal performance of pulmonary function tests at later stages of pregnancy. Exclusion will be based on self-report during screening.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Charles N. Rotimi, M.D.
National Human Genome Research Institute (NHGRI)



Hermon Feron
National Human Genome Research Institute (NHGRI)
BG 12A RM 4047
12 SOUTH DR
BETHESDA MD 20814
(301) 480-8149
hermon.feron@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03937804

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