Ph. IIa study of PC945 in Aspergillosis in Lung transplant recipients
Research type
Research Study
Full title
An open-label, pilot study to assess safety, tolerability, pharmacokinetics and effects of inhaled PC945 in the pre-emptive treatment of Aspergillus fumigatus colonisation in lung transplant recipients
IRAS ID
256412
Contact name
Jasvir Parmar
Contact email
Sponsor organisation
Pulmocide Ltd
Eudract number
2018-000240-26
Duration of Study in the UK
1 years, 2 months, 12 days
Research summary
The safety, tolerability and effects of taking inhaled PC945 (study drug) for early (‘pre-emptive’) treatment of airway infections by a fungus called Aspergillus will be studied in patients who have received a lung transplant. The amount of study drug that gets into the bloodstream and lungs will also be studied. As the study is open-label, participants will know what treatment they receive.
There are two study phases:
1. Surveillance Phase (first 12-weeks post-transplant): participants will receive preventative antifungal treatment, attend hospital visits and have bronchoscopies according to local Standard of Care (SOC). Participants who do not develop a fungal infection will participate in the non-intervention Surveillance Phase only.2. Treatment Phase (16-weeks including treatment and follow-up): Participants who develop a fungal lung infection will receive either:
- Pre-emptive PC945 treatment for 28 days (Pre-Emptive Treatment phase) if diagnosed with an early Aspergillus infection without symptoms/disease, with an optional further 8 weeks of PC945 (Extended Treatment Phase), if required,
Or:
- 'Non-intervention' group: SOC antifungal treatment and management, if the Aspergillus infection is causing symptoms/disease.Approximately 30 participants will be recruited into the Surveillance Phase from UK sites to identify 10 participants who are eligible for PC945 treatment.
All participants will have at least 2 study visits in the Surveillance Phase. Participants in the PC945 Pre-emptive Treatment Phase will have 5 study visits and will be contacted by telephone on up to 3 occasions. Participants in the 8-week Extended Treatment Phase will have 2 additional visits. Study visits and bronchoscopies will be timed to coincide with usual SOC practice where possible; participants may have additional bronchoscopy visits depending on local SOC.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0091
Date of REC Opinion
17 May 2019
REC opinion
Further Information Favourable Opinion