Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial.

ABSTRACT:

Background

The prostaglandin D₂ (PGD₂) receptor 2 (DP₂ receptor) pathway is an important regulator of the inflammatory cascade in asthma, which can be stimulated by allergic or non-allergic triggers. Fevipiprant is an oral, non-steroidal, highly selective, reversible antagonist of the DP₂ receptor that inhibits the binding of PGD₂ and its metabolites.

Methods

SPIRIT, a 2-treatment period (52-week, double-blind and optional 104-week single-blind), randomised, placebo-controlled, multicentre, parallel-group study, assessed the long-term safety of fevipiprant (150 mg and 450 mg o.d.) added to standard of care in patients ≥ 12 years with uncontrolled asthma. Stratified block randomisation was used. Patients were randomised i

SUBMITTER: Maspero J 

PROVIDER: S-EPMC8666007 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature