Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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26 July 2021 |
Main ID: |
NCT03870841 |
Date of registration:
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24/10/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis
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Scientific title:
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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 |
Date of first enrolment:
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April 3, 2019 |
Target sample size:
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4 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT03870841 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subject must be male or female, aged 18 years inclusive or older (at the time of
consent).
2. Subject must be willing and able to adhere to the restrictions and prohibitions
required by this protocol.
3. 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.
4. A confirmed diagnosis of CF by standard criteria.
5. Subject is able to produce sputum.
6. 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.
7. 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:
1. Any other disease or condition, which in the Investigator's medical opinion would
preclude the subject's participation in a clinical trial.
2. 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.
4. Is taking systemic antifungal treatment (intravenous, oral or inhaled) or has received
antifungal therapy (intravenous, oral or inhaled) within 6 weeks of Day 1.
5. If female, the subject is pregnant (e.g., has a positive serum ß human chorionic
gonadotropin (ß-hCG) at screening or a positive urinary pregnancy test pre-dose on Day
1), lactating or breast feeding.
6. Any respiratory exacerbation within 2 weeks of the start of the study.
7. Any upper respiratory tract infection or signs or symptoms thereof within 2 weeks
prior to dosing.
8. Positive culture for Mycobacterium abscessus within 12 months before screening or
between screening and baseline, or currently receiving treatment for Mycobacterium
abscessus.
9. Has chronic, active hepatitis or a positive hepatitis B surface antigen or positive
hepatitis C antibody result at screening.
10. Is taking antiretroviral protease inhibitor therapy.
11. Allergy to any of the active or inactive ingredients in the study medication.
12. History of drug (or other) allergy or intolerance that, in the opinion of the
Investigator or Pulmocide Medical Monitor, would contraindicate their participation.
13. Clinically significant haemoptysis (>200 mL per episode) within 90 days before
screening.
14. Subject is mentally or legally incapacitated. 19 July 2018 CONFIDENTIAL Page 27 of 58
Pulmocide Ltd Clinical Protocol PC_ASP_003
15. 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.
16. Any other reason that the Investigator considers makes the subject unsuitable to
participate.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aspergillosis
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Cystic Fibrosis
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Intervention(s)
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Drug: PC945
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Primary Outcome(s)
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Breathlessness visual analogue scale rating, change over time
[Time Frame: Baseline to Day 84]
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Maximum plasma concentration
[Time Frame: Baseline to Day 84]
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Adverse events (AEs)
[Time Frame: Baseline to Day 84]
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Forced vital capacity (FVC) values
[Time Frame: Baseline to Day 84]
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Concentration at the end of the dosage interval (Ctrough)
[Time Frame: Baseline to Day 84]
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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]
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Cough visual analogue scale rating, change over time
[Time Frame: Baseline to Day 84]
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Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose
[Time Frame: Baseline to Day 84]
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Maximum expiratory flow values (MEF25-75)
[Time Frame: Baseline to Day 84]
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Predicted post bronchodilator forced expiratory volume in 1 second (FEV1) values
[Time Frame: Baseline to Day 84]
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Area under the curve from time 0 to 2 h post-dose (AUC0-2)
[Time Frame: Baseline to Day 84]
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Peak expiratory flow rate values (PEFR)
[Time Frame: Baseline to Day 84]
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Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose
[Time Frame: Baseline to Day 84]
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Secondary Outcome(s)
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Cystic Fibrosis Questionnaire - Revised (CFQ-R) score
[Time Frame: Baseline to Day 84]
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Change in serum Aspergillus-specific IgE levels
[Time Frame: Baseline to Day 84]
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Change in sputum A. fumigatus measured by quantitative polymerase chain reaction (qPCR)
[Time Frame: Baseline to Day 84]
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Change in the serum concentration of A. fumigatus-specific immunoglobulins G (IgG)
[Time Frame: Baseline to Day 84]
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Sputum colour
[Time Frame: Baseline to Day 84]
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Change in the number of sputum A. fumigatus colony forming units (CFU)
[Time Frame: Baseline to Day 84]
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Sputum consistency, including presence of blood
[Time Frame: Baseline to Day 84]
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A. fumigatus status (presence or absence) in subjects with a baseline A. fumigatus-positive sputum culture
[Time Frame: Day 1 to Day 84]
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Correlation between A. fumigatus measured by qPCR and clinical response
[Time Frame: Baseline to Day 84]
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Change in serum Total immunoglobulin E (IgE) levels
[Time Frame: Baseline to Day 84]
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Secondary ID(s)
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2018-000243-87
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PC_ASP_003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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