Severe Asthma Research Program - Wake Forest University

Asthma Clinical Trial

— SARP3  

Official title:

The Severe Asthma Research Program at Wake Forest University - Longitudinal Phenomics and Genetics of Severe Asthma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750411
• Other study ID #: IRB00021507
• Secondary ID: 1U10HL109164-01
• Status: Completed
• Start date: December 2012
• Est. completion date: January 15, 2021

Study information

• Verified date: February 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 15, 2021
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Severe Persistent Asthma

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pulmonary function over time	Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).	36 months
Secondary	Frequency of severe asthma exacerbations	Frequency of severe asthma exacerbations; Utilization of hospital based care (Emergency Department, Hospitalization, ICU); Need for supplemental oral corticosteroids	36 months

External Links

•   Severe Asthma Research Program Public Website
•   Website for Clinical Studies at Wake Forest Center for Genomics and Personalized Medicine Research