Stopped: The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.
This study tests the effects of pre-emptive treatment with an experimental drug PC945 in lung transplant recipients 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 be monitored for up-to 12 weeks for the presence of Aspergillus in their lungs. Suitable participants will receive PC945 for an initial 28 days (Pre-emptive treatment phase) and, if needed, a further 8-weeks (Extended treatment phase).The amount of fungus in the patients' lungs will be measured over the course of the study. Participants with lung infections but not eligible for PC945 will be followed-up for 16-weeks on standard of care treatment. The study will take place at multiple sites in UK and 10 participants will receive PC945. The maximum study duration will be about 28 weeks.
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Adverse events (AEs)
Timeframe: 48 hours Post Transplant to Week 16 post treatment
Proportion of participants receiving PC945 who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose
Timeframe: Baseline to Week 16
Proportion of participants receiving PC945 who meet the markedly abnormal criteria for vital signs assessment at lease once post dose
Timeframe: Baseline to Week 16
Proportion of participants receiving PC945 who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose
Timeframe: Baseline to Week 16
Predicted post bronchodilator forced expiratory volume in 1 second (FEV1) values from participants receiving PC945
Timeframe: Baseline to Week 16
Forced vital capacity (FVC) values from participants receiving PC945
Timeframe: Baseline to Week 16
Area under the curve from time 0 to 2 h post-dose (AUC0-2)
Timeframe: Baseline to Week 16
Maximum plasma concentration
Timeframe: Baseline to Week 16
Concentration at the end of the dosage interval (Ctrough)
Timeframe: Baseline to Week 16