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    The EU Clinical Trials Register currently displays   39361   clinical trials with a EudraCT protocol, of which   6446   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-000978-38
    Sponsor's Protocol Code Number:DSIT-2015-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-09-02
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-000978-38
    A.3Full title of the trial
    Randomized, prospective double-blind placebo controlled study for the evaluation of the number, duration and severity of Respiratory Tract Infections in adults with risk of recurrence after standard treatment with bacterial lysates Paspat 3 mg tablets, over an observation period of six months.
    Studio randomizzato, prospettico in doppio cieco controllato verso placebo per la valutazione del numero, della durata e della gravità delle infezioni delle vie respiratorie in adulti ad elevato rischio di ricorrenza dopo trattamento standard con il lisato batterico “Paspat 3 mg compresse” nell’arco di un periodo di sei mesi di osservazione.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, prospective double-blind placebo controlled study for the evaluation of the number, duration and severity of Respiratory Tract Infections in adults with risk of recurrence after standard treatment with bacterial lysates Paspat 3 mg tablets, over an observation period of six months.
    Studio randomizzato, prospettico in doppio cieco controllato verso placebo per la valutazione del numero, della durata e della gravità delle infezioni delle alte vie respiratorie in adulti ad elevato rischio di ricorrenza dopo trattamento standard con il lisato batterico “Paspat 3 mg compresse” nell’arco di un periodo di sei mesi di osservazione.
    A.3.2Name or abbreviated title of the trial where available
    ACASP
    ACASP
    A.4.1Sponsor's protocol code numberDSIT-2015-01
    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 SponsorDAIICHI SANKYO ITALIA S.P.A.
    B.1.3.4CountryItaly
    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 supportDaiichi Sankyo Italia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Italia S.p.A
    B.5.2Functional name of contact pointDr.ssa Maria Strano-Medical Manage
    B.5.3 Address:
    B.5.3.1Street AddressVia Paolo di Dono 73
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00142
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0685255264
    B.5.5Fax number+39 0685255233
    B.5.6E-mailMaria.Strano@daiichi-sankyo.it
    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 PASPAT - 3 MG COMPRESSE 28 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderDAIICHI SANKYO ITALIA S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePASPAT 3 mg compresse
    D.3.2Product code NA
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    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
    Evaluation of clinical efficacy of Paspat 3 mg tablets in the prevention of number, duration and severity of Respiratory Tract Infections in adults with risk, defined as affected of at least 6 episodes in the previous 12 months.
    Valutare l’efficacia clinica di Paspat 3 mg compresse nella prevenzione, in termini di numero di episodi e gravità, delle infezioni ricorrenti delle vie respiratorie in adulti a rischio, definiti come affetti da almeno 6 episodi nei 12 mesi precedenti.
    E.1.1.1Medical condition in easily understood language
    Prevention of number, duration and severity of Respiratory Tract Infections in adults with risk, defined as affected of at least 6 episodes in the previous 12 months.
    Prevenzione, in termini di numero di episodi e gravità, delle infezioni ricorrenti delle vie respiratorie in adulti a rischio affetti da almeno sei episodi nei 12 mesi precedenti.
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10038133
    E.1.2Term Recurrent respiratory tract infections
    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 assess the clinical efficacy of Paspat 3 mg tablets in preventing, number and severity of recurring infections of the respiratory tract in adults at risk, testified by at least six recurrences in the previous 12 months
    Valutare l’efficacia clinica di Paspat 3 mg compresse nella prevenzione, in termini di numero di episodi e gravità, delle infezioni ricorrenti delle vie respiratorie in adulti a rischio, definiti come affetti da almeno sei episodi nei 12 mesi precedenti.
    E.2.2Secondary objectives of the trial
    To compare, active and placebo groups, the duration of RTI/LRTI and URTI in adults.
    To evaluate the consequences of RTI /LRTI and URTI on loss of working or school days, hospitalisation and use of other treatments.
    To document the safety of Paspat 3 mg tablets
    Comparare la durata degli RTI e URTI tra il gruppo che assume farmaco attivo e il gruppo che assume placebo. Valutare l’impatto di RTI / URTI su assenteismo dal lavoro o da scuola, ricovero ospedaliero, utilizzo di altri trattamenti.
    Documentare la sicurezza di Paspat 3 mg compresse.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female.
    2.Aged 18 to 80 years achieved.
    3.Patients with at least 6 RTI/LRTI or URTI episodes confirmed by medical recording or reported history, with a maximum of 18, during the 12 months prior randomization.
    4.Patients who given their written consent for participation in the study.
    5.Possibility to have regular telephone contacts with patient.
    6.Patients who are supposed will be cooperative with regard to compliance with study-related constraints.
    1.Adulti di ambo i sessi.
    2.Età compresa tra 18 e 80 anni compiuti.
    3.Pazienti con almeno 6 episodi di RTI/LRTI o URTI registrati nella cartella ambulatoriale o riportati in anamnesi, con un massimo di 18 episodi nei 12 mesi precedenti la randomizzazione.
    4.Pazienti che abbiano dato il loro consenso scritto per la partecipazione allo studio.
    5.Possibilità di avere regolari contatti telefonici con il paziente.
    6.Pazienti che possano garantire la dovuta collaborazione e compliance al trattamento ed alle procedure dello studio.
    E.4Principal exclusion criteria
    1.Women with childbearing potential not using effective contraception (oral contraceptives, intrauterine device, tubal ligation or other efficient procedures).
    2.Women referring, at the screening visit, to be pregnant or breast feeding or women likely to become pregnant during the time of the study.
    3.Previous major surgery in the oral, nasal or respiratory tracts (except tonsillectomy or adenectomy) like cleft lip, palate, nasal surgeries etc. or anatomical damage to the respiratory tracts due to intubation
    4. Anatomic abnormalities of oral, nasal or respiratory tracts.
    5.Fever at the time of randomization.
    6.Known allergic rhinitis from patient’s medical history/records not controlled by standard therapy.
    7. Acute broncho-pulmonary infection (bronchiolitis, pneumonia, tuberculosis) at the time of randomization.
    8.Chronic broncho-pulmonary disorders such as active asthma needing a continuous use of steroids (oral or inhalers) or bronchiectasis regularly treated with corticosteroids.
    9.Oral, nasal or respiratory abscess, including also chronic suppurative otitis media.
    10.Cystic fibrosis, primary abnormalities of mucociliary clearance (for example Kartagener's syndrome).
    11.Known α-1 anti-trypsin deficiency from patient’s medical history/records.
    12.Auto-immune disease (e.g. nephropathy, insulin-dependent diabetes mellitus, rheumatoid purpura, juvenile idiopathic arthritis).
    13.Acute intestinal infections.
    14.Severe systemic diseases, including Human Immunodeficiency Virus (HIV) infection, severe haematological diseases, cancer and otherwise severely compromised patients.
    15.Medical history of hypersensitivity to Paspat 3 mg tablets or any drug excipients.
    16.Any on-going specific or non-specific immunotherapy with pharmacological effects on the immune system (including homeopathic or phytotherapy) whatever route of administration, 3 months prior to inclusion and/or planned during the course of the study, except regular vaccinations.
    17. Any homeopathic or phytotherapy treatment used for preventing recurrent infections or for improving immunity in the 6 months prior randomization.
    18.Participation in another clinical trial at the time of the randomization or within 4 weeks before randomization.
    19.Patient’s or family’s difficulties or problems, in the judgment of the investigator, in being compliant with study procedures and requirements, including social or mental constrains.
    1.Donne in età fertile che non utilizzano contraccettivi efficaci (contraccettivi orali, dispositivi intrauterini, chiusura delle tube o altre procedure efficaci).
    2.Donne che, al momento della visita di screening, riferiscono di essere in stato di gravidanza o di allattamento al seno o donne che potenzialmente potrebbero rimanere incinta durante tutta la durata dello studio.
    3.Chirurgia maggiore pregressa delle vie aeree (eccetto tonsillectomia o adenoidectomia), quale interventi chirurgici per palatoschisi, o altra chirurgia nasale o al palato, ecc., oppure danni anatomici delle vie aeree causato da intubazione del tratto respiratorio
    4.Anomalie anatomiche del cavo orale, del naso o delle prime vie respiratorie.
    5.Febbre al momento della randomizzazione.
    6.Nota rinite allergica riportata in anamnesi o in cartella clinica e non adeguatamente controllata da terapie standard.
    7.Infezione broncopolmonare acuta (bronchiolite, polmonite, tubercolosi) al momento della randomizzazione.
    8.Patologie broncopolmonari croniche quali ad esempio asma attiva in trattamento cronico con steroidi (sia per via orale che per inalazione) oppure bronchiettasia in trattamento cronico con corticosteroidi.
    9.Ascessi orali, nasali o respiratori inclusa l’ otite media suppurativa cronica
    10.Fibrosi cistica, anomalia primaria a carico delle ciglia vibratili della mucosa respiratoria (ad esempio la sindrome di Kartagener).
    11.Noto deficit di alfa-1 anti-tripsina riportata in anamnesi o in cartella clinica.
    12.Malattia autoimmune (ad esempio nefropatia, diabete mellito insulinodipendente, porpora reumatoide, artrite idiopatica giovanile).
    13.Infezioni intestinali acute.
    14.Gravi patologie sistemiche, inclusa l’infezione da HIV, gravi malattie ematologiche, cancro e altre patologie in grado di compromettere gravemente le condizioni del paziente.
    15.Nota ipersensibilità a Paspat 3 mg compresse o a qualcuno dei suoi eccipienti.
    16.Qualsiasi immunoterapia specifica o non-specifica in corso con effetti farmacologici sul sistema immunitario (compresi rimedi omeopatici o fitoterapici) indipendentemente dalla via di somministrazione, nei 3 mesi precedenti l’inclusione e/o immunoterapia programmata durante lo studio, ad eccezione delle normali vaccinazioni di routine.
    17.Qualsiasi immunoterapia specifica o non-specifica (compresi rimedi omeopatici o fitoterapici) nei 6 mesi precedenti la randomizzazione
    18.Partecipazione in un altro studio clinico nei 4 mesi precedenti la randomizzazione.
    19.Soggetto per cui lo Sperimentatore prevede scarsa compliance nei confronti delle procedure e dello studio, inclusi motivi sociali o per limitate capacità cognitive.
    E.5 End points
    E.5.1Primary end point(s)
    Prevention in the number and severity of recurring infections of the respiratory tract in adults at risk, testified by at least six recurrences in the previous 12 months
    Prevenzione, in termini di numero di episodi e gravità, delle infezioni ricorrenti delle vie respiratorie in adulti a rischio, definiti come affetti da almeno sei episodi nei 12 mesi precedenti
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 4/ week 8/ week 12/week 16/ week 20/ week 28 (+ o - 1 week) after End of Treatment
    settimana 4/ settimana 8/ settimana 12/ settimana 16/ settimana 20/ settimana 28 (+ o - 1 settimana) post End of Treatment
    E.5.2Secondary end point(s)
    1) To compare, in active and placebo groups, the duration of RTI/LRTI and URTI in adults.
    2) To evaluate the consequences of RTI/LRTI and URTI on loss of working or school days, hospitalisation and use of other treatments.
    3) To evaluate physical examination and adverse events.
    1) Comparare la durata degli RTI/LRTI e URTI tra il gruppo che assume farmaco attivo e il gruppo che assume placebo.
    2) Valutare l’impatto di RTI/LRTI e URTI sul numero di giorni di assenza dal lavoro o da scuola, di ricovero ospedaliero e di utilizzo di altri trattamenti.
    3) Valutazione dell’esame obiettivo e degli eventi avversi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 4/ week 8/ week 12/week 16/ week 20/ week 28 (+ o - 1 week) after End of Treatment
    settimana 4/ settimana 8/ settimana 12/ settimana 16/ settimana 20/ settimana 28 (+ o - 1 settimana) post End of Treatment
    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 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) 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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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 Information not present in EudraCT
    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
    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
    E.8.9.2In all countries concerned by the trial years1
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 Yes
    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 state210
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 210
    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)
    according to the choice of the Investigator
    a giudizio dello sperimentatore
    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 Decision2016-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-16
    P. End of Trial
    P.End of Trial StatusCompleted
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