# Clinical Core: Exacerbation-Prone Pediatric Asthmatics and Control Populations

> **NIH NIH P01** · NATIONAL JEWISH HEALTH · 2021 · $283,106

## Abstract

The Clinical Core will implement and manage the human subjects research for the PPG
Projects. Centralizing the human subjects research activities for all projects of the Center will
save effort and cost by consolidating the necessary personnel, facilities, and resources. The
Clinical Core investigator and personnel have a successful track record with similar multi-project
clinical research protocols for over a decade. The Clinical Core approach has been validated by
preliminary studies with the investigators in this proposal.
Aim 1: Recruit, enroll, and retain study subjects. The clinical research protocol will consist
of a longitudinal, prospective study of exacerbation-prone asthmatic children (n=100) and cross-
sectional biosampling of three control groups: 1) mild, exacerbation-resistant asthmatic children
(n=100); 2) non-asthmatic, atopic children (n=50); and 3) non-asthmatic, non-atopic children
(n=50). These control groups will be used to characterize the spectrum of airway, CD4+ T cell,
and surfactant responses that are not involved in exacerbations.
 Participants will be identified for recruitment through IRB-approved means using
recruitment databases, electronic medical records, and public, clinic, and hospital
advertisements. Potential participants will be screened with a questionnaire that collects contact
information and inclusion and exclusion criteria. Regarding longitudinal follow-up of the
exacerbation-prone group, the Clinical Core team has a strong history of enrollment, recruitment,
and >90% participant retention in longitudinal studies of urban children with asthma.
Aim 2: Perform clinical characterization of participants through asthma and atopy
phenotyping and biosampling of study subjects. Phenotyping will include a determination of
asthma, atopic status, exacerbations, and asthma severity. Biosamples will include induced
sputum, nasal brush, nasal mucus, blood, and urine.
Aim 3: Provide data and sample management. The Clinical Core will provide biosample
tracking, routing, preparation and testing, and will provide de-identified data to the Projects and
the Biostatistics, Bioinformatics and Environmental Sampling Core. Phenotyping data will be
entered into a HIPPA-compliant, IRB-approved REDCap (Research Electronic Data Capture)
database (NIH/NCATS Colorado CTSI Grant Number UL1 TR001082).

## Key facts

- **NIH application ID:** 10246170
- **Project number:** 5P01HL132821-05
- **Recipient organization:** NATIONAL JEWISH HEALTH
- **Principal Investigator:** ANDREW H LIU
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $283,106
- **Award type:** 5
- **Project period:** 2017-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10246170

## Citation

> US National Institutes of Health, RePORTER application 10246170, Clinical Core: Exacerbation-Prone Pediatric Asthmatics and Control Populations (5P01HL132821-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10246170. Licensed CC0.

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