Your donation will make a difference:
Cystic Fibrosis Trust
Forum

Please Log in

Log in

Not a registered user? Register with us

This trial has been added to your watchlist.

Do you want to receive email notifications when the trial status changes?

No Yes

Unfollowing a trial will remove it from the watchlist and stop status change email notifications

Are you sure you want to unfollow this trial?

Yes, remove from watchlist

The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis

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, 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

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.

Trial Reference Number

113562

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

PC945 5mg once daily, PC945, nebulized

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

10

Last edited date

26 November 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 with one or more colonies of A. fumigatus detected using a modified standard approach.
  • Subject is able to produce sputum.
Top exclusion criteria
  • Any other disease or condition, which in the Investigator’s medical opinion would preclude the subject’s participation in a clinical trial.
  • Is taking inhaled amphotericin B or has taken it within 7 weeks of Day 1.
  • 3. Is taking systemic steroid treatment or has taken it within 4 weeks of Day 1.
  • Subjects considered to be stable on a systemic steroid dose of <15 mg for at least a month will not be excluded.

CF centres running this trial

Recruiting

Central Manchester University Hospitals NHS Foundation Trust

Address

Wythenshawe Hospital, Southmoor Road, M23 9LT

Recruitment ends

April 2020

Contact

Andy Jones

Get in touch