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    Summary
    EudraCT Number:2018-000244-26
    Sponsor's Protocol Code Number:PC-ASP-004
    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:2018-04-13
    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 number2018-000244-26
    A.3Full title of the trial
    A double-blind, placebo-controlled study to assess the effects of inhaled PC945 in the treatment of culture-positive Aspergillus or Candida fungal bronchitis in subjects with moderate to severe asthma or other chronic respiratory diseases.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see how inhaled PC945 affects a fungal infection in patients with asthma or other lung diseases.
    A.4.1Sponsor's protocol code numberPC-ASP-004
    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.3.2Product code PC945
    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.3.8INN - Proposed INNNot applicable
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary aspergillosis and candidiasis of lung
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007155
    E.1.2Term Candidiasis of lung
    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 antifungal effect of PC945 on A. fumigatus complex/A. niger complex or Candida spp. in sputum
    E.2.2Secondary objectives of the trial
    To measure the effect PC945 on lung function(FEV1 and FVC)
    To investigate the effect of PC945 on:
    -the Aspergillus burden in sputum, measured by the number of colony forming units (CFU) on fungal culture and quantitative polymerase chain
    reaction (qPCR)
    -the weight of spontaneous sputum production
    -the number of colonies of Candida in sputum culture
    -Candida albicans burden in sputum measured by qPCR
    -circulating fungal markers in particular A. fumigatus-specific IgG, markers of A. fumigatus sensitisation,clinically relevant outcome
    measures and quality of life (QoL)
    To obtain estimates of derived systemic pharmacokinetic parameters of PC945 and the potential circulating metabolite(s), if detectable,
    following single and repeat doses of inhaled PC945
    To investigate the safety of daily, inhaled doses of PC945 in subjects with moderate to severe asthma.
    To investigate the correlation between sputum Aspergillus and Candida levels measured by qPCR and clinical variables
    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. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and requirements of the study and is willing to participate.
    3. Subjects with a diagnosis of moderate to severe asthma (GINA Step 3, 4 or 5) made by a respiratory physician and treated with an inhaled steroid or other chronic respiratory disease.
    a. For subjects with asthma this must have a diagnosis shown either by:
    i. Historical evidence of:
    1. Increased airway hyper-responsiveness (methacholine PC20 <8 mg/ml).
    or
    2. Airflow obstruction (FEV1/FVC ratio of less than 70%) and short-term variations in FEV1 (>12%).
    or
    ii. Bronchodilator reversibility ≥12% or ≥200 mL improvement in FEV1 post bronchodilator after administration of a short-acting
    beta agonist at screening.
    OR
    b. Subjects with other chronic respiratory disease (such as COPD or bronchiectasis) susceptible to fungal bronchitis.
    4. Subject must have a positive sputum fungal culture with one or more colonies of A. fumigatus complex/A. niger complex or 200 or more colonies of yeast measured using a modified standard approach on one occasion obtained within the 28-day screening period.
    5. Subject must be able to produce a spontaneous sputum sample.
    E.4Principal exclusion criteria
    1. Subjects who have received more than 2 weeks of intravenous (IV), oral or inhaled antifungal therapy within 2 months of Visit 3.
    2. Subjects taking medication that could significantly increase the risks of AEs with triazoles.
    3. Subjects who are receiving antiretroviral protease inhibitors.
    4. At screening, has a clinically significant bacterial chest infection that has not been adequately treated.
    5. Subjects who have used an experimental medical device or received an experimental drug within 3 months or within a period less than five times the experimental drug’s half-life, whichever is longer, before the first dose of the study drug is scheduled.
    6. Clinically significant screening abnormalities (including, but not limited to, vital signs, ECG, laboratory tests, physical examination and spirometry) that, in the Investigator’s opinion, exclude the subject from participation in the study.
    7. Positive test at screening for hepatitis B virus infection, or antibodies to hepatitis C virus.
    8. If female, the subject is pregnant (e.g. has a positive serum β human chorionic gonadotropin at screening or a positive urinary pregnancy test pre-dose on Day 1), lactating or breast feeding.
    9. Subject is an employee or a first-degree relative of anyone employed by Pulmocide, a participating clinical trial site, or any contract research organisation involved in the study.
    10. Any other reason that the Investigator considers makes the subject unsuitable to participate.
    E.5 End points
    E.5.1Primary end point(s)
    Absence of A. fumigatus complex/A. niger complex on sputum culture at Visit 5 in subjects with an A. fumigatus complex/A. niger complex-positive sputum culture at baseline or a substantial (at least 50%) reduction in Candida spp. CFUs between baseline and Visit 5 in patients who were A. fumigatus complex/ A. niger complex negative at baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Visit 5
    E.5.2Secondary end point(s)
    • Predicted post bronchodilator FEV1 values at baseline, Visit 3, Visit 4, Visit 5 and at follow-up at Visit 6.
    • Forced vital capacity values at baseline, Visit 3, Visit 4, Visit 5 and at follow-up at Visit 6.
    • The number of sputum A. fumigatus complex/A. niger complex CFUs in fungal culture at baseline, Visit 5 and at follow-up at Visit 6.
    • Number of colonies of Candida spp. in sputum measured by the number of CFUs at baseline, Visit 5 and at follow-up at Visit 6.
    • Sputum A. fumigatus measured by qPCR at baseline, Visit 5 and at follow-up at Visit 6.
    • Spontaneous sputum weight (24-hour collection) at baseline, Visit 5 and at follow-up at Visit 6.
    • C. albicans measured by qPCR in sputum at baseline, Visit 5 and at follow-up at Visit 6.
    • The concentration of A. fumigatus-specific IgG as measured in serum at baseline, Visit 4, Visit 5 and at follow-up at Visit 6.
    • Serum Total IgE levels at baseline, Visit 4, Visit 5 and at follow-up at Visit 6.
    • A. fumigatus-specific IgE levels at baseline, Visit 4, Visit 5 and at follow-up at Visit 6.
    • St George’s Respiratory Questionnaire (SGRQ), cough (Leicester Cough Questionnaire), breathlessness (visual analogue scale [VAS]) and sputum characteristics (fresh morning sputum samples) at baseline, Visit 4, Visit 5 and at follow-up (Visit 6).
    • Asthma control questionnaire (ACQ6), Juniper Asthma QoL Questionnaire (AQLQ-J) scores at baseline, Visit 4, Visit 5 and at follow-up (Visit 6) in subjects with asthma.
    • Correlation between A. fumigatus measured by qPCR and clinical response: e.g. culture, QoL questionnaire scores, sputum weight, FVC, FEV1 and to investigate if change in sputum A. fumigatus measured by qPCR predicts clinical response.
    • Correlation between Candida albicans measured by qPCR and clinical response: e.g. culture, QoL questionnaire scores, sputum weight, FVC, FEV1 and to investigate if change in sputum Candida albicans measured by qPCR predicts clinical response.
    • Derived pharmacokinetic parameters for PC945 and the potential circulating metabolite(s), if detectable.
    • Safety parameters to be measured will include:
    • Adverse events (AEs).
    • Twelve-lead electrocardiogram (ECG; including QT interval corrected for Bazzetts formula, QT interval, QRS Interval, PR Interval and ventricular rate).
    • Vital signs (systolic and diastolic blood pressure, pulse rate [supine], respiratory rate).
    • Clinical laboratory evaluations (haematology, clinical chemistry, immunology, urinalysis).
    • Spirometry (FEV1, peak expiratory flow rate [PEFR]).
    • Antibiotic use will be listed by treatment arm.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Spirometry:baseline,Visit 3,Visit 4,Visit 5,Visit 6
    Sputum weight(24-hour collection):baseline,Visit 5,Visit 6
    Sputum culture:baseline, Visit 4,Visit 5,Visit 6
    qPCR(A. fumigatus & C. albicans):baseline,Visit 5,Visit 6
    Antibody levels (Serum total IgE and A. fumigatus-specific IgG and IgE): baseline,Visit 4, Visit 5,Visit 6
    Asthma & QoL Questionnaires:baseline,Visit 4,Visit 5,Visit 6
    ECG:Visit 1 or 2,Visit 3, Visit 4, Visit 5, Visit 6
    Vital signs:Visit 1, Visit 2, Visit 3, Visit 4, Visit 5,Visit 6
    Clinical laboratory evaluations:Visit 1 or 2,Visit 3, Visit 4, Visit 5,Visit 6.
    PK:baseline, Visit 4, Visit 5,Visit 6
    Biomarkers:baseline,Visit 4, Visit 5,Visit 6
    AEs & concomitant medication review:Visit 1, Visit 2, Visit 3, Visit 4, Visit 5, Visit 6, (telephone-day7,21, 28)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    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 years2
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state46
    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)
    Subject's care is the responsibility of their general practitioner. Subjects will revert to standard medical care following the conclusion 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 Decision2018-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-21
    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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