Clinical Trials Register

Summary
EudraCT Number:	2009-010665-23
Sponsor's Protocol Code Number:	CQAB149B2350
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:	2009-04-06
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

2009-010665-23

A.3

Full title of the trial

Estudio de 12 semanas de tratamiento, multicéntrico, randomizado, de grupos paralelos, ciego y doble enmascarado para comparar la eficacia y seguridad de indacaterol (150 µg o.d) administrado mediante SDDPI versus Tiotropio (18 µg o.d.) administrado via HandiHaler, en paciente con EPOC moderado-grave.

A.4.1

Sponsor's protocol code number

CQAB149B2350

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	Novartis Farmacéutica S.A
B.1.3.4	Country	Spain
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	No
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	Indacaterol
D.3.2	Product code	QAB149
D.3.4	Pharmaceutical form	Inhalation powder, hard capsule
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	Indacaterol
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	150
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	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	Tiotropium via the Handihaler®
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim Pharma GmbH & Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Tiotropio administrado via Handihaler®
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	Tiotropio
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	18
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	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	Inhalation powder, hard capsule
D.8.4	Route of administration of the placebo	Inhalation use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Inhalation powder
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

EPOC (Enfermedad Pulmonar Obstructiva Cronica)

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	10010952
E.1.2	Term	COPD

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Demostrar la no inferioridad de indacaterol (150 µg o.d.) versus tiotropio (18 µg o.d.) en cuanto al volumen espiratorio forzado en un segundo valle (FEV1 valle) en las 24 horas postdosis después de 12 semanas (84 días) de tratamiento en pacientes con EPOC de moderada a grave. Valle se define como la media de del FEV1 a las 23:10 y 23:45 h después de la dosis matutina del fármaco del estudio.

E.2.2

Secondary objectives of the trial

Demostrar la superioridad de indacaterol (150 µg o.d.) versus tiotropio (18 µg o.d.) en cuanto al FEV1 valle en las 24 horas postdosis después de 12 semanas (84 días) de tratamiento.
? Comparar indacaterol (150 µg o.d.) versus tiotropio (18 µg o.d.) en cuanto al área bajo la curva (AUC) estandarizada del FEV1 entre 5 min y 4 h después de la dosis matutina del día 1, día 28 y día 84.
? Comparar la espirometría de indacaterol (150 µg o.d.) versus tiotropio (18 µg o.d.) en cuanto al FEV1 y FVC durante todos los periodos de tiempo restantes

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Hombres y mujeres adultos de edad ? 40 años que hayan firmado el formulario de consentimiento informado antes de iniciar cualquier procedimiento relacionado con el estudio.
2.Pacientes ambulatorios capaces de participar con un diagnóstico de EPOC (de moderada a grave tal y como se clasifica en la Guías GOLD, 2007, véase Anexo 2) y que incluyen:
a)Antecedentes de consumo de tabaco de al menos 10 paquetes/año.
b)FEV1 postbroncodilatador < 80% y ? 30% del valor teórico normal (visita 2).
c)FEV1/FVC postbroncodilatador < 70% (visita 2).
[Post se refiere a entre 10 y 15 minutos después de la inhalación de 400 µg (4x100 µg) de salbutamol, equivalente a 4 x 90 µg de albuterol administrado mediante la boquilla, en la selección (visita 2)].

E.4

Principal exclusion criteria

1.Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de una mujer después de la concepción y hasta la finalización de la gestación, confirmado por un resultado positivo del análisis de gonadotropina coriónica humana en suero (> 5 mUI/ml).
2.Pacientes con un índice de masa corporal (IMC) superior a 40 kg/m2.
3.Pacientes que hayan tenido que recibir tratamiento con glucocorticoides sistémicos o antibióticos en las 6 semanas previas a la selección (visita 2) debido a una exacerbación de la EPOC. El paciente deberá discontinuar el estudio, en caso de que ocurra una exacerbación durante el periodo de inclusión (visitas 2-4). El paciente puede ser seleccionado de nuevo cuando cumpla los criterios de inclusión/exclusión.
4.Pacientes que necesiten oxigenoterapia para hipoxemia crónica (excluida la exacerbación de la EPOC aguda). Estos pacientes normalmente requieren una oxigenoterapia > 15 horas al día administrada en casa mediante un concentrador o cilindro de oxígeno.
5.Pacientes que hayan presentado infección del tracto respiratorio durante las 6 semanas previas a la visita 2. Los pacientes que desarrollen una infección del tracto respiratorio entre la visita 2 y la visita 4 deberán discontinuar el ensayo, pero pueden ser seleccionados de nuevo en una fecha posterior, una vez cumplan los criterios de inclusión/exclusión.
6.Pacientes con enfermedad pulmonar concomitante, p. ej., tuberculosis pulmonar (a menos que se confirme por radiografía de tórax que ya no es activa) o bronquiectasia clínicamente significativa.
7.Pacientes con antecedentes de asma (hasta la visita 2 inclusive) indicada por (pero no limitada a):
a.Inicio de síntomas respiratorios que indiquen asma (como tos, sibilancia, falta de aliento) antes de cumplir los 40 años.
b.Antecedentes de diagnóstico de asma.
8.Pacientes con diabetes Tipo I o diabetes Tipo II no controlada incluyendo pacientes con antecedentes de concentraciones de glucosa en sangre que están claramente fuera del rango normal o HbA1c > 8,0% de la hemoglobina total determinada en la visita 2.
9.Pacientes con contraindicaciones para el tratamiento de tiotropio que incluyen antecedentes patológicos de hipertrofia prostática sintomática, obstrucción del cuello de la vejiga o glaucoma de ángulo estrecho e insuficiencia renal de moderada a grave (aclaramiento de la creatinina ? 50 ml/min).
10.Pacientes que, según el criterio del investigador o del personal responsable de Novartis, tienen una anomalía de laboratorio clínicamente relevante o una afección clínicamente significativa como (aunque no limitado a) enfermedad cardiaca isquémica inestable, arritmia (excluyendo fibrilación auricular crónica estable) u otros hallazgos de ECG clínicamente significativos, hipertensión no controlada y cualquier otra enfermedad cardiaca significativa o trastornos circulatorios, hipo e hipertiroidismo no controlados, hipopotasemia, estado hiperadrenérgico o cualquier condición que según el criterio del investigador o del personal responsable de Novartis pueda comprometer la seguridad o el cumplimiento del paciente, interferir con la evaluación, o impedir la finalización del estudio.
11.Pacientes con antecedentes (o antecedentes familiares) de síndrome de QT largo, o cuyo intervalo QTc (Fridericia) medido en la visita 2 esté prolongado: > 450 ms (hombres) o > 470 ms (mujeres) tal como es evaluado según la interpretación del ECG central. Los pacientes que:
a.no sean aptos en el ECG de selección (siempre que no sea debido a fallos del equipo) no deberán ser seleccionados de nuevo;
b.no sean aptos en el ECG evaluado en el centro en la basal (visita 4) y considerados clínicamente significativos por el investigador.

E.5 End points

E.5.1

Primary end point(s)

Demostrar la no inferioridad de indacaterol (150 µg o.d.) versus tiotropio (18 µg o.d.) en cuanto al volumen espiratorio forzado en un segundo valle (FEV1 valle) en las 24 horas postdosis después de 12 semanas (84 días) de tratamiento en pacientes con EPOC de moderada a grave. Valle se define como la media del FEV1 a las 23:10 y 23:45 h después de la dosis matutina del fármaco del estudio.

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Double dummy

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.8.3

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

200

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
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	75
F.4.2	For a multinational trial
F.4.2.1	In the EEA	1013
F.4.2.2	In the whole clinical trial	1568

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

2009-05-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-05-15

P. End of Trial
P.	End of Trial Status	Completed

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