In this study 29 patients with mild to moderate persistent asthma will each receive single doses of nebulised RPL554, from the very low dose to the highest dose previously tested in the Phase Ib single ascending and multiple ascending dose (SAD and MAD) studies of the same drug in healthy subjects.
Thirty patients have been enrolled in this double-blind, placebo-controlled, six way crossover study, which will investigate the pharmacodynamic effect of nebulised RPL554 in a commercially scalable suspension formulation.
Verona Pharma's lead drug, RPL554, is a first-in-class drug currently in Phase IIa trials as a nebulised treatment for acute exacerbations of COPD in the hospital setting.
In the third part of the trial, nebulised RPL554, a novel dual PDE3/PDE4 inhibitor, was administered twice daily using a new proprietary, commercially scalable, suspension formulation to stable COPD patients with moderate disease severity for up to five-and-a-half consecutive days at doses significantly in excess of the previously used active dose.
RPL554 is currently in development as a nebulised treatment for acute exacerbations in COPD patients in a hospital or home-care setting.
Phase I and Phase II studies with RPL554 in the previous nebulised solution formulation were successfully conducted in over 100 subjects.
L), the drug development company focused on first-in-class medicines to treat respiratory diseases, today announces that the first patients have been dosed with RPL554 in a Phase 2a dose-finding trial in asthma patients using the Company's new proprietary nebulised formulation.
In this trial, up to 30 patients with mild to moderate chronic asthma will each receive single doses of nebulised RPL554, from the very low dose to the highest dose previously tested in the Phase 1b single ascending and multiple ascending dose (SAD and MAD) studies of the same drug in healthy subjects.
This study is the final part of a Phase I/II clinical trial with RPL554, using a new proprietary nebulised formulation.
The dose range, for both MAD studies, is based on the successfully completed SAD part of this trial in which nebulised RPL554 was delivered at doses up to 16x that previously shown to produce bronchodilation.
anti-tussive effects with nebulised
VRP700 in hospitalized patients with
RPL554, in nebulised
form, as a treatment for severe COPD, a significant