Phase IIa study of PC945 in Aspergillosis in Cystic Fibrosis patients
Research type
Research Study
Full title
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
IRAS ID
248009
Contact name
Joseph Stuart Elborn
Contact email
Sponsor organisation
Pulmocide Ltd
Eudract number
2018-000243-87
Duration of Study in the UK
1 years, 2 months, 2 days
Research summary
This is an open label study (where the participants will know that they are receiving the study drug), to look at the safety and effects of taking PC945 (study drug), by inhaler, to treat participants with a common airborne fungal infection, who also have Cystic Fibrosis. It will also look at how the body breaks down the study drug, the effect that the study drug has on the participant’s lung infection, and how well the participant’s lungs work.
Up to 18 participants are to be recruited, from sites in the UK.
Participants are expected to take part in the study for approximately 16 weeks. The study is split into three phases, consisting of
1. a screening phase of up to 4 weeks;
2. a 28 day treatment phase; and
3. an 8 week follow up phase.Participants will be expected to make a total of 5 visits to their study centre. In addition, participants will be contacted, by telephone, by study staff on three occasions during the treatment phase.
The study drug will no longer be available to participants at the end of the treatment phase, as it will still be being tested.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
18/ES/0124
Date of REC Opinion
10 Oct 2018
REC opinion
Favourable Opinion