PC945 for the treatment of refractory invasive pulmonary aspergillosis
A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis
This Phase 3 study aims to determine the safety, effectiveness and tolerability of PC945 (opelconazole) Nebulizer Suspension (hereinafter referred to as PC945) when administered in combination with systemic standard of care (SOC) antifungal therapy for patients with refractory invasive pulmonary aspergillosis (IPA) who are not responding well to their current SOC antifungal therapy.
PC945 is a new antifungal agent designed as an inhaled treatment and being studied for pulmonary fungal disease. In this study, patients will be randomly assigned to one of two blinded treatment groups:
1. PC945 plus SOC antifungal therapy group (approximately 2 out of every 3 participants).
2. Placebo plus SOC antifungal therapy group (approximately 1 out of every 3 participants).
The SOC treatment will be the antifungal therapy currently used at the participant’s hospital to treat IPA.
The study drug will be administered twice daily with a machine that turns the drug into a fine mist (compressor nebuliser) and inhaled through a mouthpiece. If the participants require the use of a ventilator at any time during the study, the study drug will be administered 3 times daily with a machine that uses a mesh cap with tiny holes to turn the drug into a fine mist (compressor nebuliser) and inhaled through the tubing that is attached to the ventilator.
This study is “double-blind,” meaning that neither the participants nor the study doctor will know which group they have been assigned.
The study consists of a Screening visit, a 12-week Treatment Period, and a 4-week Follow-up Period.
This is a global study and is planned to run in up to 7 sites in the UK.
North West - Haydock Research Ethics Committee
Date of REC Opinion
4 Aug 2022
Further Information Favourable Opinion