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    Summary
    EudraCT Number:2018-002949-11
    Sponsor's Protocol Code Number:601-0014
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-04-03
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-002949-11
    A.3Full title of the trial
    A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients with Allergic Bronchopulmonary Aspergillosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to test the effect of the drug Itraconazole (PUR1900) in Adult Asthmatic Patients with Allergic Bronchopulmonary Aspergillosis
    A.4.1Sponsor's protocol code number601-0014
    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 SponsorPulmatrix, Inc.
    B.1.3.4CountryUnited States
    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 supportPulmatrix, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPulmatrix, Inc
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address99 Hayden Avenue, Suite 390
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number+17813572333
    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 PUR1900
    D.3.4Pharmaceutical form Inhalation powder
    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 INNITRACONAZOLE
    D.3.9.1CAS number 84625-61-6
    D.3.9.4EV Substance CodeSUB08353MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboInhalation powder
    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
    Asthma with Allergic Bronchopulmonary Aspergillosis
    E.1.1.1Medical condition in easily understood language
    Asthma
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10006474
    E.1.2Term Bronchopulmonary aspergillosis allergic
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of multiple dose administration of PUR1900 given to adult asthmatic subjects with ABPA.
    E.2.2Secondary objectives of the trial
    To characterize the pharmacokinetics of multiple doses of inhaled PUR1900 in plasma and sputum.
    To evaluate the effect of PUR1900 on biomarkers of inflammation (sputum eosinophils and serum IgE).
    To evaluate the effect of PUR1900 on pulmonary function following single- and multiple-dose administration of PUR1900.
    To evaluate the impact of PUR1900 on respiratory symptoms, as measured by the ACQ 6.
    To evaluate the effect of PUR1900 on the Aspergillus fumigatus burden in the sputum, as assessed by quantitative PCR and sputum culture.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each subject must meet all the following criteria to be enrolled in this study:
    1.Can provide written informed consent before the performance of any study-specific procedures.
    2.Is a male or female, 18 to 75 years old (inclusive) at the time of signing the informed consent.
    3.Has a body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.
    4.Has a historical diagnosis of asthma, as per the Global Initiative for Asthma (GINA) 2018 update.
    5.Has a confirmed historical diagnosis of ABPA, as per the Modified International Society for Human and Animal Mycology (ISHAM) working group 2013 criteria.
    6.Is currently considered to be in one of the following stages of ABPA: Stage 2 (Response), Stage 4 (Remission), Stage 5a (Treatment-dependent ABPA), or Stage 5b (Glucocorticoid-dependent asthma).
    7.Has a serum immunoglobulin (Ig) E ≥1000 IU/mL during screening (Visit 1 or Visit 2).
    8.Can perform a valid, reproducible spirometry test with demonstration of a prebronchodilator FEV1 ≥50% of predicted normal for age, sex, race, and height at a screening visit.
    9.Has a documented stable asthma medication regimen during screening (Day 28 to Day 1), including SABA, LABA, and LTRA use and inhaled and/or oral GCS.
    10.Subjects who are sexually active, male subjects able to father a child, and female subjects of childbearing potential must agree to follow the contraception requirements.
    11.Can demonstrate the correct inhalation technique for the use of the delivery device at screening and before dosing on Day 1.
    12.Is willing and able to comply with all study procedures and assessments, including scheduled visits, drug dosing plan, study procedures, laboratory tests, and study restrictions.
    E.4Principal exclusion criteria
    A subject who meets any of the following criteria will be excluded from the study:
    1.Has used any anti-IgE (eg, Xolair® [omalizumab]) or anti-interleukin-5 (IL-5) biologics (eg, Cinqair® [reslizumab], Nucala® [mepolizumab], or Fasenra® [benralizumab]) in the 6 months before first dose of study drug.
    2.Is a female of childbearing potential who is pregnant or lactating or who plans to become pregnant during the study (all female subjects must have a negative pregnancy test at screening and predose on Day 1). A woman is considered to be of childbearing potential unless she is either permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation) or postmenopausal (had no menses for 12 months without an alternative medical cause).
    3.Is taking or has taken any prescribed or over-the-counter (OTC) drug that is a CYP3A4 inhibitor or substrate in the 14 days (or 5 half-lives, whichever is longer) before first dose of study drug and for the duration of the study (exclusion also applies to the whole fruit or juices of grapefruit and Seville or pomelo oranges).
    4.Is taking or has taken any herbal remedies or CYP3A4 inducers in the 28 days before first dose of study drug.
    5.Has used any systemic azole antifungal agent in the 6 months before first dose of study drug.
    6.Has a history of life-threatening asthma within the last 5 years, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures.
    7.Had an occurrence of asthma or ABPA exacerbations (as defined in Section 13.5) within the 28 days before screening or during the 28-day period before Day 1.
    8.Had an occurrence of clinically significant bacterial, viral, or fungal infection that required systemic (oral or intravenous) antibiotics, antivirals, or antifungals within the 28 days before screening. Topical treatments, other than antifungals, are allowed.
    9.Received any investigational medical product in a clinical research study within the previous 3 months before dosing in this study.
    10.Is a study site employee, an immediate family member of a study site employee, or a sponsor employee.
    11.Has previously received PUR1900.
    12.Has a history of any significant drug or alcohol abuse in the past 2 years before screening, as judged by the investigator.
    13.Has current tobacco or inhaled marijuana use or history of smoking tobacco or marijuana within the last 6 months before screening.
    14.Is a current user of e-cigarettes or has used these products within the last 6 months before screening.
    15.Has the absence of suitable veins for multiple venipunctures/cannulation as assessed by the investigator or designee at screening.
    16.Has evidence or history of clinically significant abnormal serum chemistry, hematology, or urinalysis at screening, as judged by the investigator (particularly elevation of liver enzymes or bilirubin).
    17.Has a positive urine test result for drugs of abuse, alcohol, or cotinine at screening (unless, in the opinion of the investigator, this can be explained by the subject’s current medications).
    18.Has a positive human immunodeficiency virus (HIV; type A and type B) antibody result: a subject who is HIV antibody positive is not excluded if a subsequent CD4 count is ≥200 cells/µL.
    19.Has evidence or a history of clinically significant cardiovascular, renal, hepatic, or gastrointestinal disease or neurological or psychiatric disorder, as judged by the investigator.
    20.Has evidence or a history of endocrine, immunological, or autoimmune disease that would affect the subject’s safety or confound the assessment of study endpoints in the opinion of the investigator.
    21.Has a current diagnosis of any chronic airway disease other than asthma, ABPA, or bronchiectasis believed to be related to ABPA, such as chronic obstructive pulmonary disease, pulmonary fibrosis, cystic fibrosis, or Churg-Strauss syndrome. A subject whose predominating clinical disease burden is related to bronchiectasis (eg, a subject with 2 or more infective exacerbations of bronchiectasis in the past 12 months or a subject with chronic colonization with Pseudomonas aeruginosa) will be excluded.
    22.Has evidence of ventricular dysfunction, such as congestive cardiac failure, or a history of congestive cardiac failure. N-terminal pro B-type natriuretic peptide (NT pro BNP) will be checked at screening only. A subject with a confirmed value of >400 pg/mL will not be eligible to participate.
    23.Has a 12-lead ECG demonstrating a mean QT interval corrected by the Fridericia formula (QTcF) >450 ms for a male subject or >470 ms for a female subject at screening. A repeat triplicate ECG is allowed if a mean QTcF >450 ms is recorded at Visit 1 or Visit 2.
    24.Has a serious adverse reaction or serious hypersensitivity to any of the formulation excipients.
    E.5 End points
    E.5.1Primary end point(s)
    •Incidence of treatment-emergent adverse events
    •Incidence of intraday FEV1 declines (from predose to postdose) of ≥10%, ≥15%, and ≥20%
    •Vital sign measurements (respiratory rate, blood pressure, heart rate, oxygen saturation by pulse oximetry, oral or tympanic temperature)
    •Physical examination findings
    •Clinical laboratory parameters
    •12-Lead electrocardiogram findings
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily for 28 days
    E.5.2Secondary end point(s)
    •Pharmacokinetic parameters of itraconazole and hydroxy-itraconazole in plasma, including, but not limited to, Cmax, Tmax, AUC, CL/F, and Vz/F
    •Sputum concentrations of itraconazole and hydroxy-itraconazole on Day 2, on Day 14, and at follow-up
    •Change from baseline (Day -9 to Day -6) to Day 28 in sputum eosinophil count
    •Change from baseline (Day -9 to Day -6) to Day 28 in percentage of sputum eosinophils
    •Change from baseline (Day 1) to Day 28 in IgE plasma concentration
    •Change from baseline (Day 1) to Day 28 in FEV1
    •Change from baseline (Day 1) to Day 28 in FVC, PEF, and FEV1/FVC
    •Change from baseline (Day 1) to Day 28 in ACQ-6 score
    •Change from baseline (Day 1) to Day 28 in A fumigatus burden in sputum as assessed by quantitative PCR and sputum culture
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily for 28 days
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    India
    Poland
    United Kingdom
    United States
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days19
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 64
    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
    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 Decision2019-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-07-15
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