Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-002705-19

A.3

Full 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.3.1

Title 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.3.2

Name or abbreviated title of the trial where available

OMPeR

A.4.1

Sponsor's protocol code number

OMPeR

A.5.4

Other Identifiers

Name:

OMPeR

Number:

OMPeR

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	WAIDID- WORLD ASSOCIATION FOR INFECTIOUS DISEASES
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
B.5.2	Functional name of contact point	U.O.S.D. PEDIATRIA AD ALTA INTENSIT
B.5.3	Address:
B.5.3.1	Street Address	VIA COMMENDA N. 9
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20122
B.5.3.4	Country	Italy
B.5.4	Telephone number	0255034338
B.5.5	Fax number	0250320206
B.5.6	E-mail	susanna.esposito@unimi.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Broncho- vaxom
D.2.1.1.2	Name of the Marketing Authorisation holder	OM Pharma S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Portugal
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Broncho-vaxom
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lisato battericoliofilizzato di H influenzae, S pneumoniae, K pneumoniae ssp pneumoniae e ssp ozaenae, S aureus, S pyogenes e sanguinis, M catarrhalis
D.3.9.1	CAS number	88402-38-4
D.3.9.2	Current sponsor code	-
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	BRONCHO-VAXOM
D.2.1.1.2	Name of the Marketing Authorisation holder	OM PHARMA S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Portugal
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lisato battericoliofilizzato di H influenzae, S pneumoniae, K pneumoniae ssp pneumoniae e ssp ozaenae, S aureus, S pyogenes e sanguinis, M catarrhalis
D.3.9.1	CAS number	88402-38-4
D.3.9.2	Current sponsor code	-
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Recurrent Respiratory Tract Infection

Infezioni Respiratorie Ricorrenti

E.1.1.1

Medical condition in easily understood language

Recurrent Respiratory Tract Infection

Infezioni Respiratorie Ricorrenti

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10039249
E.1.2	Term	RTI
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

6 MONTHS

6 MESI

E.5.2

Secondary 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.5.2.1

Timepoint(s) of evaluation of this end point

6 MONTHS

6 MESI

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other 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.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

200

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

CHILDREN UNABLE TO GIVE THEIR CONSENT

MINORI INCAPACI DI DARE PERSONALMENTE IL LORO CONSENSO

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

288

F.4.2

For a multinational trial

F.4.2.1

In the EEA

288

F.4.2.2

In 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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-09-06

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status

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IMP with orphan designation in the indication
Orphan Designation Number:
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