AspergillosisPhase 2NCT03870841
The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis
A Phase 2 study testing PC945 in people with Aspergillosis and Cystic Fibrosis, run by Pulmocide Ltd at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspergillosis, Cystic Fibrosis
- What is being tested?
- PC945
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 3 Apr 2019to 1 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subject must have a positive sputum fungal culture at screening with one or more colonies of A. fumigatus detected using a modified standard approach.
Who cannot join
- 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.
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- 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.
- Has chronic, active hepatitis or a positive hepatitis B surface antigen or positive hepatitis C antibody result at screening.
- Is taking antiretroviral protease inhibitor therapy.
- Allergy to any of the active or inactive ingredients in the study medication.
- History of drug (or other) allergy or intolerance that, in the opinion of the Investigator or Pulmocide Medical Monitor, would contraindicate their participation.
- Clinically significant haemoptysis (>200 mL per episode) within 90 days before screening.
- Subject is mentally or legally incapacitated. 19 July 2018 CONFIDENTIAL Page 27 of 58 Pulmocide Ltd Clinical Protocol PC_ASP_003
- Subject is employed or is a first-degree relative of anyone employed by Pulmocide, a participating clinical trial site, or any contract research organisation involved in the study.
- Any other reason that the Investigator considers makes the subject unsuitable to participate.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Brompton Hospital
London, SW3 6NP
Northwest Lung Research Centre
Manchester, M23 9LT
About this study
Official 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.
- Conditions
- Aspergillosis, Cystic Fibrosis
- Being tested
- PC945
- Medical subject headings
- Aspergillosis, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC945Drug
PC945, nebulized
| Study group | Role | What they receive |
|---|---|---|
| PC945 | Experimental | PC945 5mg once daily Receives: Drug: PC945 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: Baseline to Day 84
Proportion of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose
Measured: Baseline to Day 84
Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose
Measured: Baseline to Day 84
Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose
Measured: Baseline to Day 84
Predicted post bronchodilator forced expiratory volume in 1 second (FEV1) values
Measured: Baseline to Day 84
Forced vital capacity (FVC) values
Measured: Baseline to Day 84
Peak expiratory flow rate values (PEFR)
Measured: Baseline to Day 84
Maximum expiratory flow values (MEF25-75)
Measured: Baseline to Day 84
Breathlessness visual analogue scale rating, change over time
Symptom severity rated from "Best ever" to "Worst possible"
Measured: Baseline to Day 84
Cough visual analogue scale rating, change over time
Symptom severity rated from "Best ever" to "Worst possible"
Measured: Baseline to Day 84
Area under the curve from time 0 to 2 h post-dose (AUC0-2)
Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable
Measured: Baseline to Day 84
Maximum plasma concentration
Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable
Measured: Baseline to Day 84
Concentration at the end of the dosage interval (Ctrough)
Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable
Measured: Baseline to Day 84
Secondary outcomes (10)
Change in the number of sputum A. fumigatus colony forming units (CFU)
Measured: Baseline to Day 84
A. fumigatus status (presence or absence) in subjects with a baseline A. fumigatus-positive sputum culture
Measured: Day 1 to Day 84
Change in sputum A. fumigatus measured by quantitative polymerase chain reaction (qPCR)
Measured: Baseline to Day 84
Change in the serum concentration of A. fumigatus-specific immunoglobulins G (IgG)
Measured: Baseline to Day 84
Change in serum Total immunoglobulin E (IgE) levels
Measured: Baseline to Day 84
Change in serum Aspergillus-specific IgE levels
Measured: Baseline to Day 84
Correlation between A. fumigatus measured by qPCR and clinical response
Measured: Baseline to Day 84
Cystic Fibrosis Questionnaire - Revised (CFQ-R) score
Measured: Baseline to Day 84
Sputum consistency, including presence of blood
Categorical variable
Measured: Baseline to Day 84
Sputum colour
Categorical variable using standardised colour chart.
Measured: Baseline to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start3 Apr 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Why it stopped: The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmocide Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870841
- Sponsor's protocol ID
- PC_ASP_003
- Other IDs
- 2018-000243-87, 2018
- Status last verified
- Jul 2021
- First submitted
- 24 Oct 2018
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03870841
- Acronym / sponsor ID
- PC_ASP_003
- Conditions
- Aspergillosis, Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Pulmocide LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PC945 | Experimental | Drug: PC945PC945 5mg once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC945PC945, nebulized | Drug | PC945 |
Primary outcome
Adverse events (AEs)
Time frame: Baseline to Day 84
Proportion of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose
Time frame: Baseline to Day 84
Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose
Time frame: Baseline to Day 84
Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose
Time frame: Baseline to Day 84
Predicted post bronchodilator forced expiratory volume in 1 second (FEV1) values
Time frame: Baseline to Day 84
Forced vital capacity (FVC) values
Time frame: Baseline to Day 84
Peak expiratory flow rate values (PEFR)
Time frame: Baseline to Day 84
Maximum expiratory flow values (MEF25-75)
Time frame: Baseline to Day 84
Breathlessness visual analogue scale rating, change over time
Time frame: Baseline to Day 84
Symptom severity rated from "Best ever" to "Worst possible"
Cough visual analogue scale rating, change over time
Time frame: Baseline to Day 84
Symptom severity rated from "Best ever" to "Worst possible"
Area under the curve from time 0 to 2 h post-dose (AUC0-2)
Time frame: Baseline to Day 84
Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable
Maximum plasma concentration
Time frame: Baseline to Day 84
Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable
Concentration at the end of the dosage interval (Ctrough)
Time frame: Baseline to Day 84
Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable
10 secondary outcomes
Change in the number of sputum A. fumigatus colony forming units (CFU)
Time frame: Baseline to Day 84
A. fumigatus status (presence or absence) in subjects with a baseline A. fumigatus-positive sputum culture
Time frame: Day 1 to Day 84
Change in sputum A. fumigatus measured by quantitative polymerase chain reaction (qPCR)
Time frame: Baseline to Day 84
Change in the serum concentration of A. fumigatus-specific immunoglobulins G (IgG)
Time frame: Baseline to Day 84
Change in serum Total immunoglobulin E (IgE) levels
Time frame: Baseline to Day 84
Change in serum Aspergillus-specific IgE levels
Time frame: Baseline to Day 84
Correlation between A. fumigatus measured by qPCR and clinical response
Time frame: Baseline to Day 84
Cystic Fibrosis Questionnaire - Revised (CFQ-R) score
Time frame: Baseline to Day 84
Sputum consistency, including presence of blood
Time frame: Baseline to Day 84
Sputum colour
Time frame: Baseline to Day 84
Results and safety
The study was stopped early (reason given: The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PC945 in people with Aspergillosis and Cystic Fibrosis, run by Pulmocide Ltd at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Baseline to Day 84). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.