Prove cliniche Nct

Summary
EudraCT Number:2016-002705-19
Sponsor's Protocol Code Number:OMPeR
National Competent Authority:Italy - Italian Medicines Agency
Clinical Trial Type:EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:2018-01-22
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
A. Protocol Information
A.1Member State ConcernedItaly - Italian Medicines Agency
A.2EudraCT number2016-002705-19
A.3Full title of the trial
A phase IV, randomized, controlled, double-blind study on efficacy and safety of OM-85 in children with recurrent respiratory tract infections
Studio farmacologico di fase IV, randomizzato, controllato, in doppio cieco sull’efficacia e sicurezza di OM-85 in bambini con infezioni respiratorie ricorrenti
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A pharmacological study on efficacy and safety of OM-85 in children with recurrent respiratory tract infections
Studio farmacologico sull’efficacia e sicurezza di OM-85 in bambini con infezioni respiratorie ricorrenti
A.3.2Name or abbreviated title of the trial where available
OMPeR
OMPeR
A.4.1Sponsor's protocol code numberOMPeR
A.5.4Other Identifiers
Name:OMPeRNumber:OMPeR
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 SponsorFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
B.1.3.4CountryItaly
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 supportWAIDID- WORLD ASSOCIATION FOR INFECTIOUS DISEASES
B.4.2CountryItaly
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
B.5.2Functional name of contact pointU.O.S.D. PEDIATRIA AD ALTA INTENSIT
B.5.3 Address:
B.5.3.1Street AddressVIA COMMENDA N. 9
B.5.3.2Town/ cityMILANO
B.5.3.3Post code20122
B.5.3.4CountryItaly
B.5.4Telephone number0255034338
B.5.5Fax number0250320206
B.5.6E-mailsusanna.esposito@unimi.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 Broncho- vaxom
D.2.1.1.2Name of the Marketing Authorisation holderOM Pharma S.A.
D.2.1.2Country which granted the Marketing AuthorisationPortugal
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 nameBroncho-vaxom
D.3.4Pharmaceutical form Capsule, hard
D.3.4.1Specific paediatric formulation Yes
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 INNLisato battericoliofilizzato di H influenzae, S pneumoniae, K pneumoniae ssp pneumoniae e ssp ozaenae, S aureus, S pyogenes e sanguinis, M catarrhalis
D.3.9.1CAS number 88402-38-4
D.3.9.2Current sponsor code-
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number3.5
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.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 BRONCHO-VAXOM
D.2.1.1.2Name of the Marketing Authorisation holderOM PHARMA S.A.
D.2.1.2Country which granted the Marketing AuthorisationPortugal
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.3.4Pharmaceutical form Capsule, hard
D.3.4.1Specific paediatric formulation Yes
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 INNLisato battericoliofilizzato di H influenzae, S pneumoniae, K pneumoniae ssp pneumoniae e ssp ozaenae, S aureus, S pyogenes e sanguinis, M catarrhalis
D.3.9.1CAS number 88402-38-4
D.3.9.2Current sponsor code-
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number3.5
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
D.8.3Pharmaceutical form of the placeboCapsule, hard
D.8.4Route of administration of the placeboOral use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Recurrent Respiratory Tract Infection
Infezioni Respiratorie Ricorrenti
E.1.1.1Medical condition in easily understood language
Recurrent Respiratory Tract Infection
Infezioni Respiratorie Ricorrenti
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 10039249
E.1.2Term RTI
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 efficacy of OM-85 administered at the standard regimen (10 days for 3 consecutive months) in reducing the number of acute respiratory tract infections during the infective season in preschool children with previous recurrent respiratpry tract infections.
Valutare l’efficacia di OM-85 somministrato 10 giorni al mese per 3 mesi consecutivi nel ridurre il numero di infezioni respiratorie acute durante la stagione infettiva, in bambini di età prescolare con storia di IRR.
E.2.2Secondary objectives of the trial
assess the efficacy of OM-85 administered for 3 or 6 months in reducing the number of acute RTIs lasting (a) at least 2 days or (b) at least 3 days
assess the efficacy of OM-85 administered for 3 or 6 months in lowering the duration of acute RTIs;
assess the efficacy of OM-85 administered for 3 or 6 months in increasing the number of days free from any symptoms of RTIs;
assess the efficacy of OM-85 administered for 3 or 6 months in reducing the number of upper and lower RTIs;
assess the efficacy of OM-85 administered for 3 or 6 months in reducing the duration of upper and lower RTIs;
assess the efficacy of OM-85 administered for 3 or 6 months in reducing the number of bacterial pharyngotonsillitis and AOM;
assess the efficacy of OM-85 administered for 3 or 6 months in reducing the duration of bacterial pharyngotonsillitis and AOM
assess the efficacy of OM-85 administered for 3 or 6 months in reducing antibiotic use;
assess the efficacy of OM-85 administered for 3 or 6 months in reduci
Valutare efficacia somministrazione di OM-85 per 3 o 6 mesi nel ridurre numero episodi acuti infezioni respiratorie della durata di almeno 2 giorni o3 giorni
Valutare efficacia somministrazione OM-85 per 3 o 6 mesi nel ridurre durata episodi acuti infezioni respiratorie
Valutare efficacia somministrazione OM-85 per 3 o 6 mesi nell’aumentare numero giorni senza sintomi infezioni respiratorie
Valutare efficacia somministrazione OM-85 per 3 o 6 mesi nel ridurre durata infezioni respiratorie delle alte e basse vie
Valutare efficacia somministrazione OM-85 per 3 o 6 mesi nel ridurre numero faringotonsilliti batteriche e otiti medie acute
Valutare efficacia somministrazione OM-85 per 3 o 6 mesi nel ridurre durata faringotonsilliti batteriche e OMA
Valutare efficacia somministrazione OM-85 per 3 o 6 mesi nel ridurre uso antibiotici
Valutare efficacia somministrazione OM-85 per 3 o 6 mesi nel ridurre num visite mediche ambulatoriali
Valutare efficacia somministrazione OM-85 per 3 o 6 mesi nel
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Provision of written informed consent from parents/legal guardian prior to any study procedures
Preschool children of both gender, aged 1 to 6 years
Six or more acute respiratory tract illnesses in the previous year or 4 episodes of infectious bronchospasm (according to medical records from outpatient clinics)
Consenso scritto da parte dei genitori/tutori prima di eseguire qualsiasi procedura dello studio;
Bambini di età prescolare, di entrambi i sessi, di età compresa tra 1 e 6 anni;
Anamnesi positiva per 6 o più episodi di infezioni respiratorie acute o 4 episodi di broncospasmo su base infettiva nell’anno precedente (come documentato in cartella clinica, trattandosi di pazienti ambulatoriali)
E.4Principal exclusion criteria
Anatomic alterations of the respiratory tract
Other chronic respiratory diseases (i.e., persistent wheezing requiring stable therapy with inhalatory steroids, tuberculosis or cystic fibrosis)
Severe primary immunodeficiency or HIV infection
Any autoimmune disease
Liver or kidney failure
Malnutrition
Any known neoplasia or malignancy
Treatment with the following medications: Antibiotics, systemic, inhaled or oral steroids (e.g., oral prednisolone) within 4 weeks before Visit 1, oral vaccination with live vaccine within 4 weeks before Visit 1, long-term azithromycin therapy within 3 months before Visit 1, previous and/or concomitant immunosuppressants, Immunostimulants, gamma globulins, or anticonvulsive drugs therapy within 6 months before Visit 1
Any major surgery within the last 3 months prior to study enrolment
Known allergy or previous intolerance to study medication or to any components/excipients of the study medication;
Severe immunodeficiency.
Any other clinical conditions, in the opinion of the investigator, that would not allow safe completion of the clinical study
Parents/legal guardians not willing or unable to give written informed consent
Participant's families may not be expected to relocate out of study area within 1 year of the initiation of the study
Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or receiving other investigational agent(s).
Alterazioni anatomiche delle vie respiratorie;
Patologie respiratorie croniche (per esempio: wheezing persistente che richiede terapia cronica con steroidi inalatori, asma bronchiale, tubercolosi o fibrosi cistica);
Immunodeficienza primitiva grave o infezione da HIV
Patologie autoimmuni di qualsiasi tipo;
Insufficienza epatica o renale;
Malnutrizione;
Neoplasia o tumori maligni noti di qualsiasi tipo;
Trattamento con i seguenti farmaci: Antibiotici, steroidi sistemici, inalatori oppure orali (per esempio prednisolone per via orale) nelle 4 settimane precedenti la visita 1,
Vaccinazione con vaccino a virus vivo attenuato nelle 4 settimane precedenti la visita 1,
Terapia a lungo termine con azitromicina nei 3 mesi precedenti la visita 1,
Uso precedente/concomitante di immunosoppressori, immunostimolanti, immunoglobuline o farmaci anticonvulsivanti nei 6 mesi precedenti la visita 1.
Interventi chirurgici maggiori di qualsiasi tipo nei 3 mesi prima dell’arruolamento;
Allergia nota o precedente intolleranza al farmaco in studio o a qualsiasi altra/o componente/eccipiente dello stesso;
Immunodeficienza secondaria grave;
Qualsiasi condizione clinica che, a giudizio dello sperimentatore, potrebbe impedire il completamento dello studio;
Rifiuto o incapacità dei genitori/tutore legale a fornire il consenso informato scritto;
Intenzione da parte della famiglia del partecipante di trasferirsi fuori dall’area dello studio entro un anno dal suo inizio;
Partecipazione concomitante o terminata da meno di 30 giorni, a qualsiasi altro studio che preveda l’utilizzo di un farmaco o dispositivo medico sperimentale.
E.5 End points
E.5.1Primary end point(s)
Mean cumulative number of acute respiratory tract infections over 6 months
Numero cumulativo medio di infezioni respiratorie acute durante i 6 mesi dello studio
E.5.1.1Timepoint(s) of evaluation of this end point
6 MONTHS
6 MESI
E.5.2Secondary end point(s)
Safety, including AEs, SAEs, vital signs, physical examination and laboratory parameters
Sicurezza, inclusi AE, SAE, segni vitali, esame obiettivo e parametri di laboratorio
E.5.2.1Timepoint(s) of evaluation of this end point
6 MONTHS
6 MESI
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 Yes
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
Evaluation of the efficacy of OM85 to positively influence intestinal microbiota
VALUTAZIONE DELL'EFFICACIA DI OM85 NELL'INFLUENZARE POSITIVAMENTE IL MIOCROBIOTA INTESTINALE
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) No
E.7.4Therapeutic use (Phase IV) Yes
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 trial3
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 No
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 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 years0
E.8.9.1In the Member State concerned months9
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years0
E.8.9.2In all countries concerned by the trial months9
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: 1
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) Yes
F.1.1.4.1Number of subjects for this age range: 88
F.1.1.5Children (2-11years) Yes
F.1.1.5.1Number of subjects for this age range: 200
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) No
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 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 Yes
F.3.3.6.1Details of subjects incapable of giving consent
CHILDREN UNABLE TO GIVE THEIR CONSENT
MINORI INCAPACI DI DARE PERSONALMENTE IL LORO CONSENSO
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state288
F.4.2 For a multinational trial
F.4.2.1In the EEA 288
F.4.2.2In the whole clinical trial 288
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)
STANDARD OF CARE
I soggetti continueranno ad essere seguiti per la loro condizione clinica dal medico come da standard di cura
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 Decision2016-09-06
N.Ethics Committee Opinion of the trial application
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial Status

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

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