Clinical Trials Register

Summary
EudraCT Number:	2006-006512-30
Sponsor's Protocol Code Number:	D5890L00022
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-03-07
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

Spain - AEMPS

A.2

EudraCT number

2006-006512-30

A.3

Full title of the trial

Estudio paneuropeo abierto y de distribución aleatoria que compara la eficacia y el coste-efectividad de Symbicort como terapia de mantenimiento y a demanda (Symbicort SMART) empleando una dosis de mantenimiento con Symbicort 160/4,5 μg de 1 inhalación, dos veces al día o de 2 inhalaciones, dos veces al día, en el tratamiento de pacientes con asma persistente. EUROSMART

A.3.2

Name or abbreviated title of the trial where available

EUROSMART

A.4.1

Sponsor's protocol code number

D5890L00022

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AstraZeneca AB
B.1.3.4	Country	Sweden
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Symbicort Turbuhaler 160/4,5 microgramos polvo para inhalación
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca Farmacéutica Spain, S.A.
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	Symbicort Turbuhaler 160/4.5 micrograms
D.3.4	Pharmaceutical form	Inhalation powder
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	budesonide
D.3.9.1	CAS number	CAS-51333-22
D.3.9.2	Current sponsor code	D5890L00022
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	formoterol fumarate dihydrate
D.3.9.1	CAS number	CAS-43229-80
D.3.9.2	Current sponsor code	D5890L00022
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.5
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Information not present in EudraCT

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

Asma persistente

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Comparar la eficacia del tratamiento de mantenimiento y a demanda con Symbicort® (Symbicort® SMART), administrado durante 6 meses en dos dosis de mantenimiento diferentes a asmáticos adultos en tratamiento con Glucocorticosteroides inhalados (GI) en quienes esté indicado un agonista β2 de acción prolongada

E.2.2

Secondary objectives of the trial

- Comparar la relación coste-efectividad de Symbicort® SMART en dos dosis de mantenimiento diferentes.
- Valorar la seguridad de Symbicort® SMART en dos dosis de mantenimiento diferentes.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Visitra 1:
1. Firma del consentimiento informado. Deberá haberse obtenido el consentimiento informado firmado y fechado antes de realizar ningún procedimiento relacionado con el estudio, incluida la retirada de la medicación concomitante.
2. Pacientes ambulatorios de ambos sexos ≥ 18 años con antecedentes documentados mínimos de 6 meses de asma persistente según la definición de la American Thoracic Society (ATS 1987).
3. Uso de GI durante al menos un mes con la misma dosis diaria de al menos 500 µg de beclometasona, 400 µg de budesonida (dosis medida), 200 µg de fluticasona, 400 µg de mometasona, 250 µg de beclometasona en partículas ultrafinas ó 320 µg de ciclesonida.
4. Sujetos con antecedentes de uso de agonistas ß2 de acción rápida para alivio de los síntomas durante los últimos 30 días (SABA o formoterol).
Visita 2:
5. Uso de al menos una inhalación a demanda para alivio sintomático en al menos 4 de los últimos 7 días del período preinclusión en el caso de los sujetos con GI sin LABA, y en al menos 2 de los últimos 7 días del período preinclusión en el caso de los sujetos tratados tanto con GI como con LABA.
6. Ausencia de cambios del tratamiento de mantenimiento para el asma durante el período preinclusión.
7. Ausencia de exacerbaciones graves del asma durante el período preinclusión.

E.4

Principal exclusion criteria

1. Sujetos tratados actualmente con Symbicort® en terapia SMART.
2. Hipersensibilidad conocida o sospechada al tratamiento del estudio o a los excipientes del producto en investigación, incluida la lactosa.
3. Exacerbación del asma en los últimos 14 días previos a la visita 1 o en ella.
4. Sujetos que utilicen GC orales, rectales o parenterales durante los últimos 14 días previos a la visita 1.
5. Uso de cualquier agente betabloqueante, incluidos colirios.
6. Uso de tratamiento sistémico con inhibidores potentes de la CYP3A4 (p. ej., itraconazol, ketoconazol, ritonavir).
7. Sujetos tratados con omazilumab, broncodilatadores nebulizados o glucocorticosteroides nebulizados.
8. Sujetos de > 40 años con antecedentes tabáquicos de ≥ 10 paquetes-año.
9. Sujetos con EPOC u otra enfermedad respiratoria importante a juicio del investigador.
10. Embarazo, lactancia materna o embarazo previsto durante el estudio. Mujeres fértiles que no utilicen medidas anticonceptivas aceptables, a juicio del investigador.
11. Cualquier enfermedad o trastorno importante o hallazgo anormal de importancia clínica que, en opinión del investigador, pueden poner al sujeto en riesgo por su participación en el ensayo, o influir en los resultados del ensayo o en la capacidad del sujeto para participar en él.
12. Sospecha de una capacidad deficiente para seguir las instrucciones del estudio, por ejemplo a causa de antecedentes de abuso de sustancias, dificultad para leer o entender instrucciones o cualquier otro motivo, a criterio del investigador.
13. Asignación previa de un código de aleatorización en este estudio.
14. Participación en un estudio clínico durante los últimos 30 días.
15. Hospitalización prevista durante el estudio.
16. Participación en la planificación o la realización del estudio.

E.5 End points

E.5.1

Primary end point(s)

Tiempo hasta la primera exacerbación grave del asma, definida como empeoramiento del asma que origina:
- necesidad de glucocorticosteroides orales o sistémicos durante al menos 3 días.
- hospitalización/visita a urgencias a causa de asma que precisa glucocorticosteroides orales o sistémicos

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

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

Information not present in EudraCT

E.8.1.6

Cross over

Information not present in EudraCT

E.8.1.7

Other

Information not present in EudraCT

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

1 o 2 inhalaciones Symbicort Turbuhaler 160/4.5microgramos

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

100

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

1200

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

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

El final del ensayo se define como la fecha de bloqueo de la base de datos, que es el punto cronológico más allá del cual ningún paciente quedará expuesto a actividades relacionadas con el ensayo.
El estudio puede darse por terminado antes de que se haya alcanzado el número de sujetos previsto a iniciativa de un CEIC o de las autoridades sanitarias o debido al reclutamiento lento de los sujetos.

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
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	8150
F.4.2.2	In the whole clinical trial	8250

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

2007-04-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-04-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2008-12-01

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