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

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ClinicalTrials.gov Identifier: NCT03937804
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

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.


Condition or disease
Asthma

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).

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: New Approaches for Empowering Studies of Asthma in Populations of African Decent
Estimated Study Start Date : May 22, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
asthmatics
persons with asthma
control
persons without asthma



Primary Outcome Measures :
  1. Expand and integrate multiomic resources for asthma research in African Diaspora populations and identify novel genetic determinants for risk of asthma in CAAPA cohorts [ Time Frame: single assessment ]
    Expand and integrate multiomic resources for asthma research in African Diaspora populations and identify novel genetic determinants for risk of asthma in CAAPA cohorts



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
African American adults with asthma and healthy control register
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. Pregnant women are included as study procedures remain of minimal risk to these women. However, as the size of the growing fetus may cause mechanical difficulties in performing the pulmonary function test optimally for women at later stages of pregnancy, women who self-report pregnancy at either second or third trimester will be asked to return for testing after delivery, if they are still interested in participating.

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.

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): NCT03937804


Contacts
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Contact: Shirley Freeman (301) 451-2302 freemansh@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Human Genome Research Institute (NHGRI)
Investigators
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Principal Investigator: Charles N Rotimi, M.D. National Human Genome Research Institute (NHGRI)

Additional Information:
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Responsible Party: National Human Genome Research Institute (NHGRI)
ClinicalTrials.gov Identifier: NCT03937804     History of Changes
Other Study ID Numbers: 190092
19-HG-0092
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 13, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) ):
Trans-omics

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