Small Airways Disease (SAD) in Severe Asthma as a Novel Endpoint and Distinct Target for Mepolizumab (SASAM Study)

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Sep 2, 2021

Keywords

ClinConnect Summary

Study hypothesis We hypothesize that mepolizumab has a significant beneficial effect on small airways disease in severe asthmatics and that the evaluation of small airways before and during treatment may represent a distinctive marker of response and a novel target for a preferential use of this drug vs other biologics available for severe eosinophilic asthmatic patients.

Study objectives

* To evaluate a wide panel of validated small airways endpoints in eosinophilic severe asthmatics before mepolizumab treatment
* To evaluate longitudinal changes of these endpoints at different time poin...

Gender

ALL

Eligibility criteria

• • Male and female subjects addressed to the Asthma Center, aged ≥12 yrs with severe asthma as defined by ATS/ERS guidelines (≥12months high-dose ICS + additional controller treatments), ≥2 exacerbations (corticosteroid and/or ED visit and/or hospitalization in the previous 12 months), blood eosinophil ≥150 cells/µl at study entrance or ≥300cells/µl historically and a smoking history \<2 pack/year.