Clinical Trials Register

Summary
EudraCT Number:	2016-000979-24
Sponsor's Protocol Code Number:	DSIT-2015-02
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-06-10
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-000979-24

A.3

Full title of the trial

Randomized, prospective double-blind placebo controlled study for the evaluation of the number, duration and severity of Upper Respiratory Tract Infections in children 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 bambini 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.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

ICASP (Infant Clinical Assessment Study on Paspat).

A.4.1

Sponsor's protocol code number

DSIT-2015-02

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	Daiichi Sankyo Italia SpA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Daiichi Sankyo Italia SpA
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	Daiichi Sankyo Italia SpA
B.5.2	Functional name of contact point	Dott. Maria Strano,Medical Departme
B.5.3	Address:
B.5.3.1	Street Address	Via Paolo di Dono, 73
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00142
B.5.3.4	Country	Italy
B.5.4	Telephone number	+3906 85255264
B.5.5	Fax number	+ 39 06 85255233
B.5.6	E-mail	Maria.Strano@daiichi-sankyo.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	PASPAT 3 MG compresse 28 compresse
D.2.1.1.2	Name of the Marketing Authorisation holder	DAIICHI SANKYO ITALIA S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	PASPAT 3 mg compresse
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Tablet
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

upper respiratory tract infections in children at high risk of reccurence.

infezioni delle alte vie respiratorie in bambini ad elevato rischio di ricorrenza.

E.1.1.1

Medical condition in easily understood language

upper respiratory tract infections in children at high risk of reccurence.

infezioni delle alte vie respiratorie in bambini ad elevato rischio di ricorrenza.

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

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 clinical efficacy of Paspat 3 mg
tablets in preventing, number and severity of recurring infections of the upper respiratory tract in children 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 alte vie respiratorie in bambini a rischio, definiti come affetti da almeno sei episodi nei 12 mesi precedenti.

E.2.2

Secondary objectives of the trial

To compare, active and placebo groups,
the duration of URTI .
To evaluate the consequences of URTIson loss of working days for parents or school days for children, hospitalisation and use of other treatments.
To document the safety of Paspat 3 mg tablets

Comparare la durata degli UTRI tra il gruppo che assume farmaco attivo e il gruppo che assume placebo.
Valutare l’impatto di URTI su assenteismo (di bambini e genitori), ricovero ospedaliero, utilizzo di altri trattamenti per i bambini.
Documentare la sicurezza di Paspat 3 mg compresse.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients with all the following criteria will be eligible for inclusion in the study protocol:
1. Male or female.
2. Aged 4 to 6 years achieved.
3. Patients with at least 6 URTI episodes confirmed by medical recording or reported history, with a maximum of 18, during the 12 months prior randomization.
4. Children whose parent(s) or guardian(s) has (have) who given their written consent for participation in the study.
5. Possibility to have regular telephone contacts with patient’s parent(s).
6. Patients, and their parents, who are supposed will be cooperative with regard to compliance with study-related constraints.

I pazienti che soddisfano tutti i seguenti criteri saranno eleggibili per l’inclusione nello studio:
1. Bambini di ambo i sessi.
2. Età compresa tra I 4 e I 6 anni compiuti.
3. Pazienti con almeno 6 episodi di URTI registrati nella cartella ambulatoriale o riportati in anamnesi, con un massimo di 18 episodi nei 12 mesi precedenti la randomizzazione.
4. Bambini i cui genitori o tutori abbiano dato il loro consenso scritto per la partecipazione allo studio.
5. Possibilità di avere regolari contatti telefonici con I genitori/tutori.
6. Pazienti e genitori/tutori che possano garantire la dovuta collaborazione e compliance al trattamento ed alle procedure dello studio.

E.4

Principal exclusion criteria

1. Previous major surgery in the oral, nasal or respiratory tracts (except tonsillectomy or adenoidectomy) like cleft lip, palate, nasal surgeries etc. or anatomical damage to the respiratory tract due to intubation.
2. Anatomic abnormalities of oral, nasal or respiratory tracts.
3. Fever at the time of randomization.
4. Known allergic rhinitis from patient’s medical history/records not controlled by standard therapy.
5. Acute broncho-pulmonary infection (bronchiolitis. pneumonia, tuberculosis) at the time of randomization.
6. Chronic broncho-pulmonary disorders such as active asthma needing a continuous use of steroids (oral or inhalers) or bronchiectasis regularly treated with corticosteroids.
7. Oral, nasal or respiratory abscess, including also chronic suppurative otitis media.
8. Cystic fibrosis, primary abnormalities of mucociliary clearance (for example Kartagener's syndrome).
9. Known α-1 anti-trypsin deficiency from patient’s medical history/records.
10. Auto-immune disease (e.g. nephropathy, insulin-dependent diabetes mellitus, rheumatoid purpura, juvenile idiopathic arthritis).
11. Acute intestinal infections.
12. Severe systemic diseases, including Human Immunodeficiency Virus (HIV) infection, severe haematological diseases, cancer and otherwise severely compromised patients.
13. Medical history of hypersensitivity to Paspat 3 mg tablets or any drug excipients.
14. 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.
15. Any homeopathic or phytotherapy treatment used for preventing recurrent infections or for improving immunity in the 6 months prior randomization.
16. Participation in another clinical trial at the time of the randomization or within 4 weeks before randomization.
17. 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. 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
2. Anomalie anatomiche del cavo orale, del naso o delle prime vie respiratorie.
3. Febbre al momento della randomizzazione.
4. Nota rinite allergica riportata in anamnesi o in cartella clinica e non adeguatamente controllata da terapie standard.
5. Infezione broncopolmonare acuta (bronchiolite, polmonite, tubercolosi) al momento della randomizzazione.
6. 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.
7. Ascessi orali, nasali o respiratori inclusa l’ otite media suppurativa cronica
8. Fibrosi cistica, anomalia primaria a carico delle ciglia vibratili della mucosa respiratoria (ad esempio la sindrome di Kartagener).
9. Noto deficit di alfa-1 anti-tripsina riportata in anamnesi o in cartella clinica.
10. Malattia autoimmune (ad esempio nefropatia, diabete mellito insulinodipendente, porpora reumatoide, artrite idiopatica giovanile).
11. Infezioni intestinali acute.
12. Gravi patologie sistemiche, inclusa l’infezione da HIV, gravi malattie ematologiche, cancro e altre patologie in grado di compromettere gravemente le condizioni del paziente.
13. Nota ipersensibilità a Paspat 3 mg compresse o a qualcuno dei suoi eccipienti.
14. 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.
15. Qualsiasi immunoterapia specifica o non-specifica (compresi rimedi omeopatici o fitoterapici) nei 6 mesi precedenti la randomizzazione
16. Partecipazione in un altro studio clinico nei 4 mesi precedenti la randomizzazione.
17. Soggetto per cui lo Sperimentatore prevede scarsa compliance nei confronti delle procedure e dello studio da parte del genitore/i (o tutore legale) per qualsiasi motivo incusi motivi sociali o per limitate capacità cognitive.

E.5 End points

E.5.1

Primary end point(s)

Prevention in the number and severity of
recurring infections of the upper respiratory tract in children at risk, testified by at least six recurrences in the previous 12 months

Valutazione del numero di episodi e gravità, delle infezioni ricorrenti delle alte vie respiratorie (URTI) in bambini di età compresa tra i 4 e i 6 anni a rischio, definiti come affetti da almeno sei episodi nei 12 mesi precedenti.

E.5.1.1

Timepoint(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.5.2

Secondary end point(s)

1) To compare, in active and placebo
groups, the duration URTIs in adults.
2) To evaluate the consequences URTIs on loss of school days, hospitalisation and use of other
treatments.
3) To evaluate physical examination and adverse events.

1) Comparare la durata degli URTI tra il gruppo che assume farmaco attivo e il gruppo che assume placebo.
2) Valutare l’impatto di URTI sul numero di giorni di assenza del bambino dall’asilo nido/scuola materna o da scuola, di ricovero ospedaliero e di utilizzo di altri trattamenti.
3) Valutare il questionario della qualità della vita dei genitori (PAR-ENT QoL)
4) Valutazione dell’esame obiettivo e degli eventi avversi.

E.5.2.1

Timepoint(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.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

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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)

Yes

E.7.4

Therapeutic use (Phase IV)

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

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

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:

210

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)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

210

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

Bambini

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-07-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-21

P. End of Trial
P.	End of Trial Status	Ongoing

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