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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 : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

Tracking Information
First Submitted Date May 3, 2019
First Posted Date May 6, 2019
Last Update Posted Date July 19, 2019
Estimated Study Start Date July 24, 2019
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03937804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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 Decent
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).
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population African American adults with asthma and healthy control register
Condition Asthma
Intervention Not Provided
Study Groups/Cohorts
  • asthmatics
    persons with asthma
  • control
    persons without asthma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 3, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
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. 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Shirley Freeman (301) 451-2302 freemansh@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03937804
Other Study ID Numbers 190092
19-HG-0092
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
Study Sponsor National Human Genome Research Institute (NHGRI)
Collaborators Not Provided
Investigators
Principal Investigator: Charles N Rotimi, M.D. National Human Genome Research Institute (NHGRI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date July 2, 2019