An observational study in Asthma and Severe Persistent Asthma, sponsored by Wake Forest University. Completed at 2 sites in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Wake Forest University · Observational
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 87 is below the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
The target recruitment goal for each center is 75% adults (age 18 and older) and 25% children age 6-17 years. Within the pediatric age group, an attempt will be made to enroll equal numbers of children 6-11 and 12-17 years of age. Similarly, an attempt will be made to enroll at least 50% females and 30% minorities.
Given the mission of SARP, a diverse sample of subjects with asthma is needed to gain better understanding of asthma and its endotypes. Because there are a number of respiratory disorders that may be confused with asthma or confound asthma assessment, SARP enrollees must meet the all following eligibility criteria as outlined below:
Evidence of historical reversibility, including either:
Exclusion Criteria:
Severe Asthma Not severe Asthma
Change in pulmonary function over time
Pulmonary function test results include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).
Time frame: 36 months
Frequency of severe asthma exacerbations
Frequency of severe asthma exacerbations * Utilization of hospital based care (Emergency Department, Hospitalization, ICU) * Need for supplemental oral corticosteroids
Time frame: 36 months
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Wake Forest University