Clinical trial NCT03937804: New Approaches for Empowering Studies of Asthma in Populations of African Descent
Official title: New Approaches for Empowering Studies of Asthma in Populations of African Descent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Trans-omics
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2019-05-06
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African American adults with asthma and healthy controls

Brief summary: 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.

...

Detailed description: Asthma is a complex disease where the interplay between genetic factors and environmental exposures controls susceptibility and disease progression. In the U.S., there remains an epidemic of asthma that disproportionately affects underrepresented minorities and creates a major public health burden, especially among children. Asthmatics of African ancestry continue to have more severe asthma and more severe clinical symptoms than their non-African counterparts, but few studies have focused on this vulnerable group. The purpose of this study is to expand our previous study, the Consortium on Asthma among African-ancestry Populations in the Americas (CAAPA) to integrate multi-omic resources for asthma research in African Diaspora populations and by recruiting new participants. The protocol described herein refers to the recruitment that will take place at the NIH Clinical Center as part of the expansion of CAAPA (CAAPA2).

Eligibility criteria: * 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.

Primary outcomes:
measure: Expand and integrate multi-omic resources for asthma research in African Diaspora populations and identify novel genetic determinants for risk of asthma in CAAPA cohorts
timeFrame: single assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Human Genome Research Institute (NHGRI)
name: Charles N Rotimi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: