The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis (NCT03870841) | Clinical Trial Compass
TerminatedPhase 2
The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis
Stopped: The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.
United Kingdom4 participantsStarted 2019-04-03
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject must be male or female, aged 18 years inclusive or older (at the time of consent).
. Subject must be willing and able to adhere to the restrictions and prohibitions required by this protocol.
. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and requirements of the study and that they are willing to participate.
. A confirmed diagnosis of CF by standard criteria.
. Subject is able to produce sputum.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events (AEs)
Timeframe: Baseline to Day 84
2
Proportion of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose
Timeframe: Baseline to Day 84
3
Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose
Timeframe: Baseline to Day 84
4
Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose
Timeframe: Baseline to Day 84
5
Predicted post bronchodilator forced expiratory volume in 1 second (FEV1) values
. Subject must have a positive sputum fungal culture at screening with one or more colonies of A. fumigatus detected using a modified standard approach.
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.
. 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.
. Is taking systemic antifungal treatment (intravenous, oral or inhaled) or has received antifungal therapy (intravenous, oral or inhaled) within 6 weeks of Day 1.
. If female, the subject is pregnant (e.g., has a positive serum β human chorionic gonadotropin (β-hCG) at screening or a positive urinary pregnancy test pre-dose on Day 1), lactating or breast feeding.
. Any respiratory exacerbation within 2 weeks of the start of the study.
. Any upper respiratory tract infection or signs or symptoms thereof within 2 weeks prior to dosing.
. Positive culture for Mycobacterium abscessus within 12 months before screening or between screening and baseline, or currently receiving treatment for Mycobacterium abscessus.
8
Maximum expiratory flow values (MEF25-75)
Timeframe: Baseline to Day 84
9
Breathlessness visual analogue scale rating, change over time
Timeframe: Baseline to Day 84
10
Cough visual analogue scale rating, change over time
Timeframe: Baseline to Day 84
11
Area under the curve from time 0 to 2 h post-dose (AUC0-2)
Timeframe: Baseline to Day 84
12
Maximum plasma concentration
Timeframe: Baseline to Day 84
13
Concentration at the end of the dosage interval (Ctrough)