Severe Asthma Research Program - Wake Forest University

The mission of the SARP is to improve the understanding of severe asthma to develop better
treatments. The SARP will gain a better understanding of asthma and its endotypes, in
children and adults, by defining the disease at the molecular and cellular levels in the
context of the temporal phenotypic expression of the disease. To this end, the SARP
investigators will utilize both mechanistic and evoked phenotype approaches to: 1)
characterize developmental molecular, cellular and physiologic phenotypes in children and
adults with mild to severe asthma, and 2) to further elucidate the evolving pathobiology and
pathogenesis of severe asthma and its sub-phenotypes and 3) compare these features over time.
This approach involves a shared longitudinal protocol conducted across all participating
centers which includes common information on all SARP participants. Additionally, SARP
investigators have each identified mechanistic research questions to be included in the
shared longitudinal protocol. At Wake Forest University investigators are specifically
interested in genetic influences on disease severity and the use of statistical modeling
techniques to better understand disease phenotypes. Together, these longitudinal and
mechanistic approaches will enable prediction of phenotype stability/fluctuation and
pharmacologic responses and identification of novel, disease-modifying targets for treatment.

Inclusion Criteria:

1. Physician diagnosis of asthma,

2. Age 6 years and older

3. Evidence of historical reversibility, including either:

- FEV1 bronchodilator reversibility ≥ 12%, or

- Airway hyperresponsiveness reflected by methacholine PC20≤16 mg/mL.

Exclusion Criteria:

1. No primary medical caregiver

2. Pregnancy (only if undergoing methacholine challenge or bronchoscopy)

3. Current smoking

4. Smoking history > 10 pack years if ≥ 30 years of age or smoking history >5 pack years
if < 30 years of age (Note: If a subject has a smoking history, no smoking within the
past year)

5. Other chronic pulmonary disorders associated with asthma-like symptoms, including (but
not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic
bronchitis, vocal cord dysfunction that is the sole cause of asthma symptoms, severe
scoliosis or chest wall deformities that affect lung function, or congenital disorders
of the lungs or airways

6. History of premature birth before 35 weeks gestation

7. Planning to relocate from the clinical center area before study completion