Clinical Trials Register

Summary
EudraCT Number:	2013-003145-42
Sponsor's Protocol Code Number:	DEXAURP
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-10-18
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

Spain - AEMPS

A.2

EudraCT number

2013-003145-42

A.3

Full title of the trial

PILOT RANDOMISED CONTROLLED TRIAL USIDNG DEXAMETHASONE VESUS PREDNISOLONA/PREDNISONA IN CHILDREN WITH ACUTE ASTHMA IN PEDIATRIC EMERGENCY WARD

ENSAYO CLÍNICO PILOTO, ALEATORIZADO, CONTROLADO DEL USO DE DEXAMETASONA FRENTE A UN CICLO DE PREDNISOLONA/PREDNISONA EN LAS CRISIS ASMÁTICAS EN NIÑOS EN UN SERVICIO DE URGENCIAS DE PEDIATRÍA

A.3.1

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

COMPARISON OF TWO DIFFERENT CORTICOIDS TREATMENTS WITH POWER AND ADMINISTRATION ON THE TREATMENT OF IN CHILDREN WITH ACUTE ASTHMA IN PEDIATRIC EMERGENCY

COMPARACION DE DOS TRATAMIENTOS CORTICOIDEOS CON DIFERENTES POTENCIAS Y PAUTAS EN EL TRATAMIENTO DE LA CRISIS DE ASMA EN NIÑOS EN LA URGENCIA PEDIATRICA

A.3.2

Name or abbreviated title of the trial where available

DEXAMETHASONE VERSUS PREDNISONA/PREDNISOLONA IN ACUTE ASTHMA IN CHILDREN

DEXAMETASONA VERSUS PREDNISONA/PREDNISOLONA EN CRISI ASMATICA EN NIÑOS

A.4.1

Sponsor's protocol code number

DEXAURP

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	FRANCISCO JAVIER BENITO FERNANDEZ
B.1.3.4	Country	Spain
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	HOSPITAL UNIVERSITARIO CRUCES (OSAKIDETZA)
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	HOSPITAL UNIVERSITARIO CRUCES (OSAKIDETZA)
B.5.2	Functional name of contact point	FRANCISCO JAVIER BENITO FERNANDEZ
B.5.3	Address:
B.5.3.1	Street Address	PLAZA CRUCES S/N
B.5.3.2	Town/ city	BARAKALDO
B.5.3.3	Post code	48903
B.5.3.4	Country	Spain
B.5.4	Telephone number	349460060006601
B.5.5	Fax number	34946006451
B.5.6	E-mail	franciscojavier.benitofernandez@osakidetza.net

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	Se utilizará el nombre comercial de este principio activo que este disponible en el Hospital
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	DEXAMETHASONE
D.3.2	Product code	DEXAMETHASONE
D.3.4	Pharmaceutical form	Oral suspension
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	DEXAMETHASONE
D.3.9.1	CAS number	50-02-2
D.3.9.4	EV Substance Code	SUB07017MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	No
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	Se utilizará el nombre comercial de este principio activo que este disponible en el Hospital
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	PREDNISOLONA
D.3.2	Product code	PREDNISOLONA
D.3.4	Pharmaceutical form	Oral suspension
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	PREDNISOLONE
D.3.9.1	CAS number	8056-11-9
D.3.9.3	Other descriptive name	PREDNISOLONE
D.3.9.4	EV Substance Code	SUB10018MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	13
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	No
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: 3
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	Se utilizará el nombre comercial de este principio activo que este disponible en el Hospital
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	PREDNISONA
D.3.2	Product code	PREDNINSONA
D.3.4	Pharmaceutical form	Tablet
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	PREDNISONA
D.3.9.1	CAS number	53-03-2
D.3.9.3	Other descriptive name	PREDNISONE
D.3.9.4	EV Substance Code	SUB10020MIG
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	30
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	No
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

ASTHMA

ASMATICA

E.1.1.1

Medical condition in easily understood language

ACUTE ASTHMA

CRISIS ASMATICA

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10049585
E.1.2	Term	Infantile asthma
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Determine whether administration of 2 doses of oral dexamethasone is as effective or more effective than the administration of prednisolone 5 days / oral prednisone in the improvement of symptoms of asthma

Determinar si la administración de 2 dosis de dexametasona oral es más efectivo o tan efectivo como la administración de 5 días de prednisolona/prednisona oral en la mejoría de los síntomas de asma.

E.2.2

Secondary objectives of the trial

Determine whether the administration of 2 doses of oral dexamethasone is more effective or as effective as 5-day administration of prednisolone / oral prednisone in the prevention of relapse and re-visits to the emergency room.
To assess the safety and tolerability of the treatment given in this context.

Determinar si la administración de 2 dosis de dexametasona oral es más efectivo o tan efectivo como la administración de 5 días de prednisolona/prednisona oral en la prevención de recaídas y reconsultas a urgencias
Valorar la seguridad y tolerancia del tratamiento administrado en este contexto.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Children admitted SUP aged 1 to 16 years.
With acute asthma: any child with respiratory symptoms (cough, shortness of breath, tachypnea) attributed to bronchospasm (wheezing, prolonged expiration, hypoventilation, etc ...), regardless of the possible trigger (infection, mites, pollen, etc ...) or the presence or absence of previous episodes.
Children after initial treatment with salbutamol (1 dose) did not exhibit clinical improvement and require treatment with systemic corticosteroids.
He has informed the patient and their parents / guardians have been given sufficient time and opportunity to consider their participation and have given consent.
Subject is willing and able to meet all the requirements of the study.

Niños ingresados en el SUP de edades entre 1 y 16 años.
Con diagnóstico de crisis asmática: todo niño con síntomas respiratorios (tos, dificultad respiratoria, taquipnea) atribuidos a broncoespasmo (sibilancias, espiración alargada, hipoventilación, etc...), sin tener en cuenta el posible desencadenante (infección, ácaros, pólenes, etc...) ni la existencia o no de episodios previos.
Niños que tras tratamiento inicial con salbutamol (1 dosis) no presentan mejoría clínica y precisan tratamiento con corticoides sistémicos.
Se ha informado al paciente y sus padres/tutores, se les ha dado el tiempo suficiente y la oportunidad para considerar su participación y han otorgado su consentimiento.
El sujeto está dispuesto y es capaz de cumplir todos los requisitos del estudio.

E.4

Principal exclusion criteria

Patients with other airway pathology not define as asthma.
Patients with concomitant diseases that make it advisable hospital treatment.
Patients requiring advanced stabilization of the airway.
Any problem of cultural, social, disease or problem of any kind that do presuppose the absence of collaboration possible for the patient and / or their legal representatives.
Patients and / or guardians / parents who do not sign the informed consent.

Los pacientes con otra patología de la vía aérea que no definamos como asma.
Pacientes con patologías concomitantes que hagan aconsejable su tratamiento hospitalario.
Pacientes que requieran estabilización avanzada de la vía aérea.
Cualquier problema de tipo cultural, social, enfermedad ó problema de cualquier tipo que haga presuponer la posible inexistencia de colaboración por para del paciente y/o sus representantes legales.
Pacientes y/o tutores/padres que no firmen el consentimiento informado.

E.5 End points

E.5.1

Primary end point(s)

Percentage of children with persistent symptoms at 7 days after hospital discharge with oral steroid therapy (dexamethasone versus prednisone / prednisolone) following an acute asthma attack.

Porcentaje de niños con persistencia de síntomas a los 7 días tras el alta hospitalaria con tratamiento corticoideo oral (dexametasona frente a prednisona/prednisolona), tras una crisis aguda de asma.

E.5.1.1

Timepoint(s) of evaluation of this end point

During the participation of the child in the trial (7 days)

Durante la participación del niño en el ensayo (7 días)

E.5.2

Secondary end point(s)

Percentage of children requiring hospitalization after their stay in the observation unit
Percentage of patients requiring a stay in the observation unit before discharge to home
Percentage of children who require hospitalization after a revisit
Adherence to treatment with oral corticosteroids
Percentage of children who have episodes of vomiting during oral corticosteroid treatment
Satisfaction of parents with corticosteroid treatment assigned to their children
Revisit to the emergency room or your primary care pediatrician at 7 and 15 days after discharge to home
Truancy days from the onset of the acute episode until the incorporation of the child to school
Absenteeism days of the mother, father and / or guardian from the beginning of the acute episode to recovery of child

Porcentaje de niños que requieren hospitalización tras su estancia en la unidad de observación
Porcentaje de pacientes que requieren una estancia en la unidad de observación previo al alta a su domicilio
Porcentaje de niños que requieren hospitalización tras una reconsulta
Adherencia al tratamiento con corticoides orales
Porcentaje de niños que tienen episodios de vómitos durante el tratamiento corticoides orales
Grado de satisfacción de los padres con el tratamiento corticoideo asignado a sus hijos
Reconsulta al servicio de urgencias o a su pediatra de atención primaria a los 7 y 15 días tras el alta a su domicilio
Días de absentismo escolar desde el inicio del episodio agudo hasta la incorporación del niño al colegio
Días de absentismo laboral de la madre, padre y/o tutor legal desde el inicio del episodio agudo hasta la recuperación del niño

E.5.2.1

Timepoint(s) of evaluation of this end point

During the participation of the child in the trial (15 days)

Durante la participación del niño en el ensayo (15 días)

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)

Yes

E.8.2.2

Placebo

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.8.5

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

The completion of the test correspond to the date on which the last visit is performed or the last follow-up contact with the last patient enrolled. Be notified via fax or mail to the competent authorities by the Promoter (or UEC-AI Cruces University Hospital should be delegated this function), filing a copy in the Developer Documentation.

La finalización del ensayo corresponderá con la fecha en la que se realiza la última visita ó el último contacto de seguimiento con el último paciente reclutado. Se notificará vía fax o mail a las autoridades competentes por parte del Promotor (o de la UEC-AI del Hospital Universitario Cruces en caso de ser delegada dicha función), archivándose una copia en la Documentación del Promotor.

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

E.8.9.2

In all countries concerned by the trial 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:

1000

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:

100

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

600

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

300

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

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

PEDIATRIC POPULATION

POBLACION PEDIATRICA

F.4 Planned number of subjects to be included

F.4.1

In the member state

1000

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1000

F.4.2.2

In the whole clinical trial

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)

CONTINUE WITH BASAL TREATMENT FOR ASTHMA

CONTINUAR CON SU TRATAMIENTO BASAL PARA EL ASMA

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-02-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-24

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

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