About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

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

Clinicaltrials.gov identifier NCT03937804

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted October 8, 2020

Study Description

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
  • Intervention/Treatment:
  • Phase: N/A
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 Design
  • 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 Descent
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: September 2021
  • Estimated Study Completion Date: September 2021
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (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.

Contacts and Locations
Contacts

Contact: Hermon Feron (301) 480-8149 hermon.feron@nih.gov

Locations

United States, Maryland
National Institutes of Health Clinical Center
Bethesda

Sponsors and Collaborators

National Human Genome Research Institute (NHGRI)

Investigators

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

More Information
  • 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: October 8, 2020
  • Last Verified: December 2019
  • Keywords provided by National Human Genome Research Institute (NHGRI): Trans-omics
  • Additional relevant MeSH terms: Asthma