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The Effect of an Anti-Fungal medicine (PC945) on Aspergillus Fumigatus Lung Infection in Patients with Cystic Fibrosis Details

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Anti-Infective

Trial status

Open to recruitment

Participating Centres
Phase
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

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
the name of the treatment or therapy being researched

Anti-fungal agent

Recruitment target
the number of participants who need to be recruited for the trial in the UK

18

Last edited date

29 October 2019

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

CF centres running this trial

Recruiting

Central Manchester University Hospitals NHS Foundation Trust

Address

Trust Headquarters Cobbett House Manchester Royal Infirmary Oxford Road Manchester Greater Manchester M13 9WL

Recruitment ends

March 2020

Contact

Jones, Andy

Get in touch

Recruiting

Royal Brompton and Harefield NHS Foundation Trust

Address

Royal Brompton Hospital Sydney Street London SW3 6NP

Recruitment ends

March 2020

Contact

Nick Simmonds

Get in touch