Severe Asthma Research Program (SARP)- San Francisco Clinical Site (SARP)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Clinical and Molecular Phenotypes of Severe Asthma|
- Lung function decline [ Time Frame: Enrollment, 1 year, 2 years, 3 years ] [ Designated as safety issue: Yes ]Changes in lung function parameters over time.
- Exacerbation frequency [ Time Frame: Monthly for 3 years ] [ Designated as safety issue: Yes ]Number of oral corticosteroid requiring exacerbations of asthma
- Inflammatory cellular markers [ Time Frame: Enrollment, 1 year, 2 years, 3 years ] [ Designated as safety issue: Yes ]Changes in inflammatory cellular markers in sputum, exhaled breath, and blood.
Biospecimen Retention: Samples With DNA
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Those with mild-to-moderate persistent asthma as defined by the NAEPP EPR-3 guidelines.
Major Criteria: (1 required)
Minor Criteria: (2 required)
Those without asthma or other chronic lung disease.
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, the SARP-SF has identified mechanistic research questions to be included in the shared longitudinal protocol. This will be explored through additional sample collections of sputum and fluids and biopsied tissue collected by bronchoscopy. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718197
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||John V Fahy, MD, MSc||University of California, San Francisco|