Phase IIa study of PC945 in Aspergillosis in Cystic Fibrosis patients

Details

Therapeutic category
Anti-Infective
Trial status
Closed to recruitment - in follow up Participating Centres
Phase
Phase II

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

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.
Trial Reference Number
108550
Trial type
Medication
Intervention
Anti-fungal agent
Recruitment target
5
Last edited date
11/07/2018
CF sponsor
Pulmocide Ltd
CF sponsor type
Commercial

Who can take part?

Age
18+
Top inclusion criteria
  • A history of persistently positive A. fumigatus sputum cultures from at least 2 sputum samples in the last year, the most recent of which must have been within the last 6 months.
  • Positive sputum fungal culture at screening
  • Subject is able to produce sputum
  • Age 18 years or older
Top exclusion criteria
  • Is taking inhaled amphotericin B or has taken it within 7 weeks of Day 1.
  • Is taking systemic steroid treatment or has taken it within 4 weeks of Day 1 (unless stable on systemic steroid dose of <15 mg)
  • Is taking systemic antifungal treatment

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