NCT03870841

The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis

An Open-label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled PC945 in Adult Cystic Fibrosis (CF) Patients With Persistent Pulmonary Aspergillus Fumigatus Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Pulmocide Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study tests the effects of an experimental drug PC945 in people with cystic fibrosis whose lungs are infected by the fungus Aspergillus fumigatus. PC945 may be useful in treating patients infected with Aspergillus fumigatus as, unlike the usual treatments, it is inhaled into the lung and has been designed to stay there and treat the infection. Participants will continue to be treated with their usual cystic fibrosis treatment and will also receive PC945. The amount of fungus in the patients' phlegm will be measured over the course of the study. The study will take place at multiple sites in UK and will include approximately 18 participants. The maximum study duration will be about 16 weeks.

Conditions

• Aspergillosis
• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	PC945	PC945, nebulized

Timeline

• Start date: 2019-04-03
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2019-03-12
• Last updated: 2021-07-16

Locations

2 sites across 1 country: United Kingdom