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    Summary
    EudraCT Number:2011-005799-41
    Sponsor's Protocol Code Number:LOC/11-17-ATCF
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-08-21
    Trial 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 number2011-005799-41
    A.3Full title of the trial
    Azole Therapy in Cystic Fibrosis (ATCF) : Efficacy of itraconazole and of
    voriconazole in patients with cystic fibrosis and presenting with
    persistent positive sputums for Aspergillus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Azole Therapy in Cystic Fibrosis (ATCF)
    A.3.2Name or abbreviated title of the trial where available
    Azole Therapy in Cystic Fibrosis (ATCF)
    A.4.1Sponsor's protocol code numberLOC/11-17-ATCF
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01576315
    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 SponsorCHU de Rennes (Rennes University Hospital Centre)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPFIZER
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportPFIZER
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportVaincre la Mucoviscidose
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportPFIZER
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Rennes
    B.5.2Functional name of contact pointDirection de la Recherche
    B.5.3 Address:
    B.5.3.1Street Address2 rue Henri Le Guilloux
    B.5.3.2Town/ cityRennes cedex 9
    B.5.3.3Post code35033
    B.5.3.4CountryFrance
    B.5.4Telephone number0033 0 2992825555
    B.5.5Fax number0033 0 299283722
    B.5.6E-maildrc@chu-rennes.fr
    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 Yes
    D.2.1.1.1Trade name SPORANOX
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameSporanox 10 mg/ml Oral Solution
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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.3.9.3Other descriptive nameSPORANOX
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name V-Fend
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameVFEND 40 mg/ml powder for oral suspension
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvoriconazole
    D.3.9.1CAS number 137234-62-9
    D.3.9.3Other descriptive nameVfend
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic fibrosis
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10003486
    E.1.2Term Aspergillus infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We wish to ascertain the effectiveness of the two possible treatments for Aspergillus infection in CF (voriconazole and itraconazole) and compare these to each other. Effectiveness will be assessed by the effect on growth of Aspergillus in the sputum, which we will also confirm with more sensitive techniques based on detecting Aspergillus DNA.
    E.2.2Secondary objectives of the trial
    We are also interested in how quality of life and severity of CF symptoms respond to treatment of Aspergillus infection, how long the treatment needs to be given to be effective, what side effects patients experience (and how these differ between treatments) and how easy it is for CF patients to achieve effective drug levels. To do this we will measure the following outcomes:
    •Quality of life
    •Effect on lung function (forced expiratory volume in 1 second)
    •Use of additional antibiotics and steroids (often given to CF patients when unwell, so a valid measure of clinical status)
    •Drug absorption will be monitored by looking at levels of the antifungal agents in the blood.
    •Time to effect on sputum cultures of Aspergillus.
    •Effect of treatment on measures of allergic response to Aspergillus.
    •Side effect and safety profiles.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age greater than or equal to 18 years,
    - patient with cystic fibrosis,
    - presenting with a positive sputum culture for Aspergillus confirmed
    twice : within 6 months entry and within 2 weeks of inclusion
    - Written informed consent for adult patients.
    E.4Principal exclusion criteria
    - patients with a contraindication to one of the antifungal agents
    evaluated,
    - pregnant women or nursing mothers,
    - absence of an effective method of contraception in women of childbearing
    potential,
    - patients with signs or symptoms of invasive aspergillosis,
    - patients with signs or symptoms of aspergilloma,
    - patients with an infection caused by Burkholderia Cepacia complex or
    mycobacteria,
    - lung transplant patients, registered on a transplantation waiting list or
    whose registration is imminent,
    - patients who received systemic antifungal therapy for more than 5
    days within 2 months prior to inclusion,
    - patients currently enrolled in another clinical drug trial,
    - ongoing treatment with medicinal products contraindicated with
    itraconazole and voriconazole or with major interactions which reduce
    azole concentrations,
    - patients treated by medication known to prolong QT interval, or with
    known prolongation of QTc interval > 450 msec in men and > 470 msec
    in women,
    - inability to follow or to understand the study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The primary evaluation criterion is the percentage of patients with a negativisation of sputum aspergillus cultures in 2 successive samples, according to a standardised technique.

    We have given priority to the course and outcome of sputum aspergillus culture as the primary criterion because it is objective and indisputable. Given the confounding factors which can interfere in clinical criteria (progressive episode of the disease, viral or bacterial infectious complication, etc.)the latter will be analysed as secondary criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    At 2 weeks after initiation of therapy :
    - measurement of plasma concentrations of antifungal agents and
    testing at 4 weeks in case of dose adjustment,
    - safety of AFs including measurement of hepatic transaminases,
    - number of courses of steroids and antibiotics and adverse events
    recording,
    At 4, 8, 16 and 24 weeks after initiation of therapy :
    - quality of life self-questionnaire scores (appendix 3), dyspnoea scale
    scores, 6 minute walking test, FEV1 value, and number of courses of
    steroids and antibiotics,
    - course of different laboratory test indicators (sputum culture and PCR,
    IgG, total and specific IgE, eosinophilia),
    - safety of the antifungal agents.
    At 1 month after the end of treatment :
    - clinical examination with a 6 minute walking test, FEV1 value, number
    of courses of steroids and antibiotics, and adverse events recording,
    - and a final sputum collection.
    After the end of treatment :
    - analysis of mycological failures (defined as persistence of a positive
    culture) by a study over time of the course and outcome of fungal
    biodiversity of isolates (sequential study of chemosensitivity to different
    antifungal agents and molecular typing).
    a study of the anti-inflammatory effect of azoles by measurement of
    serum and pulmonary pro-inflammatory cytokines (measurement of proinflammatory
    cytokines in the supernatants of the sputum (TNF-α,
    interleukin (IL)-8, IL-6, MMP1, MMP2, MMP9, EMMPRIN, MPO and free
    radicals) relating to the Group on Inflammation of the Federation of the
    CRC-CF (M. Fayon) and our research unit EA SeRAIC 4427 (University of
    Rennes 1).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 2, 4, 8, 16 and 24 weeks after initiation of therapy, and 1 month after
    the end of the treatment.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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
    The date of the end of the study corresponds to the last visit of the last person who is a subject in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    It will not be different from the expected normal treatment of that condition.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-04
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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