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    Summary
    EudraCT Number:2018-000243-87
    Sponsor's Protocol Code Number:PC_ASP_003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-08-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-000243-87
    A.3Full title of the trial
    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.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in people with cystic fibrosis who have a fungal lung infection, looking at the safety of inhaled PC945, it's effect on the body and how the body affects the drug.
    A.4.1Sponsor's protocol code numberPC_ASP_003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPulmocide Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPulmocide Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPulmocide Ltd
    B.5.2Functional name of contact pointDirector of Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressOffice Suite 3.01, 44 Southampton Buildings
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2A 1AP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+447766250133
    B.5.6E-mailLindsey@pulmocide.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePC945
    D.3.4Pharmaceutical form Nebuliser suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePC945
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary aspergillosis
    E.1.1.1Medical condition in easily understood language
    Fungal infection of the airway
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10059259
    E.1.2Term Pulmonary aspergillosis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To investigate the safety and tolerability of once daily treatment with inhaled PC945 for 28 days in adult subjects with CF who have persistent pulmonary Aspergillus fumigatus infection
    • To obtain estimates of derived systemic pharmacokinetic parameters of PC945 and the potential circulating metabolite(s), if detectable, following single and repeat doses of PC945
    E.2.2Secondary objectives of the trial
    To investigate the effect of PC945 on:
    - A. fumigatus burden in sputum, measured by the number of CFUs, on fungal culture
    - The conversion of sputum culture from A. fumigatus +ve to A. fumigatus -ve
    - A. fumigatus burden in sputum measured by qPCR
    - A. fumigatus-specific IgG levels
    - Clinically relevant outcome measures, in particular QoL, cough, breathlessness and sputum characteristic
    - Markers of A. fumigatus sensitisation: total IgE in subjects with elevated Total IgE levels at study entry, A. fumigatus-specific IgE in subjects with elevated levels of A. fumigatus-specific IgE at study entry

    To determine if changes in sputum A. fumigatus concentrations on qPCR are related to measures of fungal burden in sputum
    To investigate correlation between sputum A. fumigatus levels measured by qPCR and clinical variables including CF QoL questionnaire and lung function and to investigate if changes in sputum A. fumigatus measured by qPCR predict clinical response
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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 β human chorionic gonadotropin (β-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.
    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.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability parameters:
    • Adverse events (AEs)
    • Twelve-lead electrocardiogram (ECG; including QT corrected according to Bazett’s formulae interval, QT interval, QRS Interval, PR Interval and ventricular rate).
    • Vital signs (systolic and diastolic blood pressure, heart rate and respiratory rate)
    • Clinical laboratory evaluations (haematology, clinical chemistry, and urinalysis)
    • Spirometry (FEV1, FVC, MEF25-75 and PEFR)
    • Visual analogue score (VAS) to assess tolerability (cough, breathlessness)

    Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable including:
    • Maximum plasma concentration
    • Concentration at the end of the dosage interval (Ctrough)
    • Area under the curve from time 0 to 2 h post-dose (AUC0–2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    AEs: study related AEs from consent until Day (D) 1. All AEs from D1 until end of study
    ECGs: Screening (S), D1 (predose (PD), 0.5, 2 h), D14 (PD, 0.5, 2 h), D32-36, D84
    Vitals: S, D1 (PD,0.5, 1, 1.5, 2 h), D14 (PD, 0.5, 1, 1.5, 2 h), D32-36, D84
    Clin labs: S, D1, 14, 32-36, 84
    Spirometry: S, D1 (PD,0.5 h), D14 (PD, 0.5 h), D32-36, D84
    VAS: D1 (PD,0.5 h), D14 (PD, 0.5 h), D32-36, D84

    PK: D1 (PD,0.5, 1, 1.5, 2 h), D14 (PD, 0.5, 1, 1.5, 2 h), D32-36, D84
    E.5.2Secondary end point(s)
    • Change in the number of sputum A. fumigatus CFU from baseline to Visit 3, Visit 4 and at followup (Visit 5)
    • A. fumigatus status (presence or absence) at Visit 3, Visit 4 and at follow-up Visit 5 in subjects with an A. fumigatus-positive sputum culture at baseline
    • Change in sputum A. fumigatus measured by qPCR from baseline to Visit 3, Visit 4 and at followup Visit 5
    • Change in the serum concentration of A. fumigatus-specific IgG from baseline to Visit 3, Visit 4 and at follow-up Visit 5
    • Change in serum Total IgE levels from baseline to Visit 3, Visit 4 and at follow-up Visit 5
    • Change in serum Aspergillus-specific IgE levels from baseline to Visit 3, Visit 4 and at follow-up Visit 5
    • CFQ-R scores, cough (visual analogue scale), breathlessness (visual analogue scale) and sputum characteristics (e.g. colour, quality) at baseline, Visit 3, Visit 4, and at follow-up at Visit 5
    • Correlation between A. fumigatus measured by qPCR and clinical response: e.g., culture, CFQ-R and lung function (FEV1, FVC, MEF25–75 and PEFR) and to investigate if the change in sputum A. fumigatus measured by qPCR predicts clinical response
    E.5.2.1Timepoint(s) of evaluation of this end point
    Sputum: S, D14, 32-36, 84
    Blood samples for circulating biomarkers: D1, 14, 32-36, 84
    CFQ-R: D1, 14, 32-36, 84
    Lung function: S, D1 (PD,0.5 h), D14 (PD, 0.5 h), D32-36, D84
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None. Subjects will return to the care of their usual Doctor. PC945 will not be available after the end of the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-06-01
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