NCT03937804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 23, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

April 8, 2026

Status Verified

August 21, 2025

Enrollment Period

1.8 years

First QC Date

May 3, 2019

Last Update Submit

April 7, 2026

Conditions

Keywords

Trans-omicsNatural History

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    single assessment

Study Arms (2)

asthmatics

persons with asthma

control

persons without asthma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

African American adults with asthma and healthy controls

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Charles N Rotimi, M.D.

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 6, 2019

Study Start

September 23, 2019

Primary Completion

July 15, 2021

Study Completion

November 15, 2021

Last Updated

April 8, 2026

Record last verified: 2025-08-21

Data Sharing

IPD Sharing
Will share

All collected IPD to be shared with CAAPA2 research team. De-identified IPD to be shared with CAAPA2 investigators. De-identified IPD will be shared with appropriate NIH-sponsored databases such as dbGAP and data underlying a publication may be shared with a journal requiring it for publication.

Shared Documents
STUDY PROTOCOL
Time Frame
IPD has been shared with CAAPA2 Investigators at the time of collection. Data will be deposited in repositories and/or with journals at the time of publication.
Access Criteria
Other CAAPA2 Investigators from the Consortium may request access to de-identified data from all CAAPA2 sites (including this one) with an analysis plan (association studies or omics analyses) that is approved by the research team. Data shared with repositories will be controlled-access and require IRB approval.

Locations