Clinical Trials Register

Summary
EudraCT Number:	2015-003093-32
Sponsor's Protocol Code Number:	RC25/13
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:	2016-01-14
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

2015-003093-32

A.3

Full title of the trial

Randomized controlled trial to evaluate the efficacy of high flow versus low flow oxygen therapy in bronchiolitis

Trial controllato randomizzato per valutare l'efficacia dell'ossigenoterapia con alti flussi vs ossigenoterapia a bassi flussi nella bronchiolite

A.3.1

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

Viral respiratory distress in infants < 6 months treated with high or low fluxes of oxygen

Difficoltà respiratorie in bambini di età > a 6 mesi trattate con ossigeno ad alti o bassi flussi

A.3.2

Name or abbreviated title of the trial where available

High or low fluxes of Oxygen in Bronchiolitis

Ossigeno ad alti o bassi flussi nella bronchiolite

A.4.1

Sponsor's protocol code number

RC25/13

A.5.4

Other Identifiers

Name:

Number:

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	IRCCS Burlo Garofolo
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	IRCCS Burlo Garofolo
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	IRCCS Burlo Garofolo
B.5.2	Functional name of contact point	Dr. Alessandra Maestro
B.5.3	Address:
B.5.3.1	Street Address	via dell'Istria 65/1
B.5.3.2	Town/ city	Trieste
B.5.3.3	Post code	34137
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390403785418
B.5.5	Fax number	00390403785411
B.5.6	E-mail	alessandra.maestro@burlo.trieste.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	OSSIGENO AIR LIQUIDE SANITÀ 200 BAR GAS MEDICINALE COMPRESSO
D.2.1.1.2	Name of the Marketing Authorisation holder	AIR LIQUIDE SANITA' SERVICE S.p.A. - Via A. Capecelatro, 69 – 20148 Milano
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	OSSIGENO AIR LIQUIDE SANITÀ 200 BAR GAS MEDICINALE COMPRESSO
D.3.4	Pharmaceutical form	Inhalation solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
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	Comparator
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	OSSIGENO AIR LIQUIDE SANITÀ 200 BAR GAS MEDICINALE COMPRESSO
D.2.1.1.2	Name of the Marketing Authorisation holder	AIR LIQUIDE SANITA' SERVICE S.p.A. - Via A. Capecelatro, 69 – 20148 Milano
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	OSSIGENO AIR LIQUIDE SANITÀ 200 BAR GAS MEDICINALE COMPRESSO
D.3.4	Pharmaceutical form	Inhalation solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Bronchiolitis

Bronchiolite

E.1.1.1

Medical condition in easily understood language

Viral respiratory distress in infants < 6 months

Difficoltà respiratorie di natura virale in infanti di età < a 6 mesi

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	18.1
E.1.2	Level	PT
E.1.2	Classification code	10006448
E.1.2	Term	Bronchiolitis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the effectiveness of treatment with high flow than the standard in children with bronchiolitis admitted to a pediatric emergency department.

Valutare l'efficacia del trattamento con alti flussi rispetto a quello standard nei bambini con bronchiolite ricoverati presso un Pronto Soccorso pediatrico.

E.2.2

Secondary objectives of the trial

Not applicable

Non applicabile

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects diagnosed with bronchiolitis who present at the Emergency Departments with the following inclusion criteria:
• Diagnosis of bronchiolitis
• Age <6 months
• SaO2 <92%
• Respiratory rate> 60 breaths / min
• severe dyspnea (RDAI score ≥8)

Soggetti con diagnosi di bronchiolite che si presentano presso i Pronto Soccorsi partecipanti e che soddisfano i seguenti criteri di inclusione:
• Diagnosi di bronchiolite
• Età <6 mesi
• SaO2 <92%
• Frequenza respiratoria >60 atti/min
• dispnea severa (RDAI score ≥8)

E.4

Principal exclusion criteria

Exclusion criteria will be the presence of:
• syndromes and chronic diseases
• respiratory diseases (eg. Broncodisplasie)
• heart disease
• preterm birth (patients born before 36 weeks of gestational age)

Criteri di esclusione saranno la presenza di:
• sindromi o patologie croniche
• patologie respiratorie (es. broncodisplasie)
• patologie cardiache
• nascita pretermine (pazienti nati prima delle 36 settimane di età gestazionale)

E.5 End points

E.5.1

Primary end point(s)

Primary endpoint of the study is the time (measured in hours) of oxygen from its beginning to the suspension related to clinical improvement, defined as persistent for at least 3 hours in the air environment SaO2> 92% associated with respiratory and heart rate within the 90th percentile by age. Therefore, since the start of oxygen every two hours in the first six hours and then every 6 hours until the suspension of oxygen, the vital signs of the children enrolled will be assessed, trying to lower the administration of gas (l / minute or FI02) so to obtain a saturation> 92% with the lowest possible concentration of oxygen, up to a complete suspension.

Esito primario dello studio è il tempo (misurato in ore) di ossigenoterapia dal suo inizio alla sospensione legata al miglioramento clinico definito come persistenza per almeno 3 ore in aria ambiente della SaO2 >92% associati ad una frequenza respiratoria e cardiaca entro il 90°centile per età. Pertanto dall’avvio dell’ossigenoterapia ogni 2 ore nelle prime sei ore e quindi ogni 6 ore fino alla sospensione dell’ossigenoterapia si valuteranno i parametri vitali dei bambini arruolati, provando ad abbassare la somministrazione del gas (l/minuto o Fi02) di modo da ottenere una saturazione >92% con la minor concentrazione possibile di ossigeno, fino ad una completa sospensione.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 days

3 giorni

E.5.2

Secondary end point(s)

Secondary endpoints:
or the number of patients referred to intensive care
or number of patients intubated;
or the number and type of complications;
or number of days of parenteral hydration or nutrition through a nasogastric tube.

Esiti secondari :
- numero di pazienti inviati in terapia intensiva
- numero di pazienti intubati;
- numero e tipologia di complicanze;
- numero di giorni di idratazione parenterale o di alimentazione tramite sondino nasogastrico.

E.5.2.1

Timepoint(s) of evaluation of this end point

7 days

7 giorni

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

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)

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Lo stesso farmaco ma utilzzato con ossigeno ad alti flussi al posto dei bassi flussi

The same drug but administered with high fluxes instead of low fluxes of oxygen

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

Ultima visita dell'ultimo paziente

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

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:

130

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)

Yes

F.1.1.3.1

Number of subjects for this age range:

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)

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

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

Pediatric populations

Popolazione pediatrica

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

130

F.4.2

For a multinational trial

F.4.2.1

In the EEA

130

F.4.2.2

In the whole clinical trial

130

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)

- RDAI score will be performed at the beginning of oxygen therapy, 24 hours and in case of exit from the study or access to intensive care.
- It will run a 'blood gases before oxygen therapy in both groups

- L'RDAI score verrà eseguito all'inizio dell'ossigenoterapia, 24 ore dopo ed in caso di uscita dallo studio od accesso in terapia intensiva.
- Verrà eseguito un' emogasanalisi prima dell'avvio dell'ossigenoterapia in entrambi i gruppi

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

2016-06-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-01-12

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

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