Severe Asthma Research Program - Wake Forest University

Completed

• Conditions: Severe Persistent Asthma; Asthma

• Registration Number: NCT01750411
• Lead Sponsor: Wake Forest University

Brief Summary

The mission of SARP is to improve the understanding of severe asthma through the integrated study of the effect of genetics on the clinical and biological features of asthma and to investigate how these change over time. The ultimate goal of these efforts is to promote better treatments for severe asthma.

Detailed Description

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Primary Completion: 2020-02-18
• Study Completion: 2021-01-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pulmonary function over time	36 months	Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).

Secondary Outcome Measures

Name	Time	Method
Frequency of severe asthma exacerbations	36 months	Frequency of severe asthma exacerbations; * Utilization of hospital based care (Emergency Department, Hospitalization, ICU); * Need for supplemental oral corticosteroids

Trial Locations

Locations (2)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States