Severe Asthma Research Program (SARP)- San Francisco Clinical Site (SARP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01718197|
Recruitment Status : Active, not recruiting
First Posted : October 31, 2012
Last Update Posted : June 25, 2019
|Condition or 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.
|Study Type :||Observational|
|Estimated Enrollment :||749 participants|
|Official Title:||Clinical and Molecular Phenotypes of Severe Asthma|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
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.
- Lung function decline [ Time Frame: Enrollment, 1 year, 2 years, 3 years ]Changes in lung function parameters over time.
- Exacerbation frequency [ Time Frame: Monthly for 3 years ]Number of oral corticosteroid requiring exacerbations of asthma
- Inflammatory cellular markers [ Time Frame: Enrollment, 1 year, 2 years, 3 years ]Changes in inflammatory cellular markers in sputum, exhaled breath, and blood.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|