Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-002408-42
    Sponsor's Protocol Code Number:ASPER-III-19-1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-02-13
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-002408-42
    A.3Full title of the trial
    A Phase 3, Double Blind, Multicentric, Randomised, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of Itraconazole Dry Powder for Inhalation for the Prevention of Invasive Mould Disease in Patients with Acute Leukaemia and Neutropaenia
    Een fase 3, dubbelblinde, multicentrische, gerandomiseerde, placebogecontroleerde studie ter beoordeling van de werkzaamheid, veiligheid en verdraagbaarheid van itraconazol droog poeder voor inhalatie ter preventie van invasieve schimmelziekte bij patiënten met acute leukemie en neutropenie
    Étude de phase III, en double aveugle, multicentrique, randomisée, contrôlée par placebo, visant à évaluer l’efficacité, la sécurité d’emploi et la tolérabilité de l’itraconazole en poudre sèche pour inhalation dans la prévention des infections fongiques invasives chez des patients atteints de leucémie aiguë et de neutropénie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study aiming at proving the efficacy, safety and tolerability of inhaled Itraconazole in the prevention of Invasive Mould Disease (infections of the lungs by fungi) in patients with Acute Leukaemia and Neutropaenia (abnormally low concentration of neutrophils in the blood)
    A.4.1Sponsor's protocol code numberASPER-III-19-1
    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 SponsorLABORATOIRES SMB S.A.
    B.1.3.4CountryBelgium
    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 supportLABORATOIRES SMB S.A
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLABORATOIRES SMB S.A
    B.5.2Functional name of contact pointCLINICAL DEPARTMENT
    B.5.3 Address:
    B.5.3.1Street Address26-28 Rue de la Pastorale
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1080
    B.5.3.4CountryBelgium
    B.5.4Telephone number+322411 48 28
    B.5.5Fax number+32 2411 28 28
    B.5.6E-mailDpt_Clinique@smb.be
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2024
    D.3 Description of the IMP
    D.3.1Product nameITRACONAZOLE 4.8 mg
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 number4.8
    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 Yes
    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, hard capsule
    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
    prevention of invasive mould disease
    E.1.1.1Medical condition in easily understood language
    Infection of the lungs by fungi
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003488
    E.1.2Term Aspergillosis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether prophylaxis with ITZ DPI can reduce the incidence rate of IMD in patients with acute leukaemia undergoing remission induction chemotherapy
    E.2.2Secondary objectives of the trial
    -To investigate the safety and tolerability of ITZ DPI in patients with acute leukaemia undergoing remission-induction chemotherapy
    -To evaluate the PK of ITZ DPI in patients with acute leukaemia undergoing remission induction chemotherapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female patients ≥12 years of age
    2.Patients with new or relapsed ALL or AML who cannot receive posaconazole for any reason and who are to undergo remissioninduction chemotherapy
    3.Current neutropaenia resulting from the diagnosis of new or relapsed acute leukaemia or patients with expected neutropaenia for at least 10 days (an absolute neutrophil count <500 cell/mm3 or 0.5 x 109 cell/L) following remission-induction chemotherapy
    4.Able to have all Screening tests performed quickly to ensure results can be obtained and evaluated before randomisation, so that the first dose of study drug for the prevention of IMD can be administered as soon as possible within 5 days of the start of remission induction chemotherapy. In ALL patients, as soon as possible within 5 days of the start of remission-induction chemotherapy means as soon as possible within 5 days of the start of high dose steroid therapy.
    5.Able to comply with all study procedures, including the use of inhalers
    6.If patient is a female of childbearing potential (FOCP), patient must agree to abstain from sexual intercourse or to use an effective means of birth control (oral contraceptives, intrauterine device [IUD], condoms and spermicides, vaginal ring, hormonal patch, implants), as determined by the Investigator from the first dose of study drug until 100 days following the last dose of study drug. A female patient is considered to be of childbearing potential if she has reached menarche and a) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries), or b) has not been postmenopausal for 12 consecutive months (i.e., has had menses at any time during the preceding 12 months). Female patients of childbearing potential must also provide a negative blood pregnancy test at the Screening Visit. Male patients must be vasectomised, abstain from sexual intercourse, or agree to use barrier contraception (condom with
    spermicide), and also agree not to donate sperm from the first dose of study drug until 100 days following the last dose of study drug.
    7.Patients (and/or the patient's parents or legally authorised representatives) must give written informed consent to participate in the study by signing and dating the Informed Consent Form (ICF)/Adolescent Assent Form (to be obtained prior to initiation of any study procedure)
    E.4Principal exclusion criteria
    1.Proven, probable, or possible IMD (according to 2019 European Organisation for Research and Treatment of Cancer/Mycoses Study Group Education and Research Consortium [EORTC/MSGMSGERC] criteria at Screening or in the patient's medical history
    2.Pulmonary complications or active infiltrates associated with an ongoing pulmonary disease assessed by a chest CT
    3.Patients with ventricular dysfunction defined as ejection fraction <55% at Screening
    4.Concomitant or previous treatment with a mould-active antifungal drug within 30 days, unless the plasma level is below the limit of detection or ≥5 half-lives of the antifungal has elapsed since the
    treatment was given.
    5.Participating in another clinical trial with exposure to any investigational drug within 30 days prior to Screening, with the exception of the current anti-leukemic treatment
    6.Pregnant or nursing females
    7.Any severe co-morbidity other than underlying haematological disease that may interfere with study procedures or affect the patient's safety
    8.Grade 3 laspartate aminotransferase (ASAT >5 × upper limit of normal (ULN), alanine aminotransferase (ALAT >5 × ULN, or total bilirubin >3 × ULN.
    9.Any contraindication or hypersensitivity to the use of fluconazole or ITZ or the excipient (mannitol) in the study drug and placebo formulations
    10.Co-administration of astemizole, atorvastatin, bepridil, cisapride, dihydroergotamine, dofetilide, eletriptan, ergometrine (erginovine), ergotamine, erythromycin, levacetylmethadol (levomethadyl),
    lovastatin, methylergometrine (methylergonovine), midazolam, mizolastine, nisoldipine, pimozide, quinidine, sertindole, simvastatin, terfenadine and triazolam.
    11.Abnormal QT interval corrected by Fridericia (QTcF): males >450 ms and females >470 ms
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the:
    •Proportion of patients with proven or probable IMD at EOT. Diagnoses of proven or probable IMD will be evaluated according to 2019 EORTC/MSGERC criteria, as assessed by the Independent Data Review
    Board (IDRB) that will be blinded to treatment assignment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    •Treatment success at EOT (success defined as patients who completed treatment without developing a proven, probable, or possible IMD, without requiring systemic mould-active antifungal treatment, without discontinuation from the study due to an adverse event [AE], and who are alive).
    •The proportion of patients:
    o with proven, probable, or possible IMD at EOT and EOS
    o who had neutropaenia ≥10 days and with proven, probable, or possible IMD at EOT and EOS
    o with radiographic pulmonary infiltrates according to the central image reader at EOT and EOS
    o with bronchopulmonary aspergillosis at EOT and EOS
    o with fungal sinusitis at EOT and EOS
    o with proven or probable or possible IA at EOT and at EOS
    o with candidemia/candidiasis at EOT and EOS
    o requiring systemic mould-active antifungal treatment at EOT and EOS to treat a breakthrough fungal disease
    o alive at EOT and EOS
    o who died at EOT and EOS due to IMD or IA
    o in complete remission of their underlying malignancy at EOT and EOS
    •The proportion of pathogenic moulds causing proven and probable IMDs at EOT and EOS
    •Time to:
    o diagnosis of proven, probable, or possible IMD
    o diagnosis of IA
    o the onset of systemic mould-active antifungal treatment for a breakthrough fungal disease
    o death of any cause
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of treatment and end of study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Belgium
    Bulgaria
    Greece
    Italy
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Ukraine
    E.8.7Trial has a data monitoring committee Yes
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 23
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 23
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 339
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 281
    F.4.2.2In the whole clinical trial 462
    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 Decision2020-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-28
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 10:58:44 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA