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 (OPERA-T study)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511281-36-00

Acronym

PC_ASP_006

Enrollment

Registered

2024-12-06

Start date

2022-11-17

Completion date

2025-12-19

Last updated

2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Invasive Pulmonary Aspergillosis

Brief summary

Number of Participants with Complete or Partial Overall Response up to 12 Weeks (Day 84)

Detailed description

Time to Complete or Partial Overall Clinical Response up to 12 Weeks (Day 84)

Interventions

DRUGPC945

DRUGPC945 Placebo Nebuliser Liquid

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of Participants with Complete or Partial Overall Response up to 12 Weeks (Day 84)	—

Secondary

Measure	Time frame
Time to Complete or Partial Overall Clinical Response up to 12 Weeks (Day 84)	—

Countries

Austria, Belgium, France, Germany, Greece, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026