Clinical Trials Register

Summary
EudraCT Number:	2012-003973-24
Sponsor's Protocol Code Number:	ZEP117115
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:	2013-01-23
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

2012-003973-24

A.3

Full title of the trial

A Multicenter Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily with Tiotropium 18 mcg Once Daily over 24 Weeks in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Ensayo multicéntrico para comparar la eficacia y seguridad de umeclidinio/vilanterol, 62,5/25 µg una vez al día, con tiotropio, 18 µg una vez al día, durante 24 semanas en sujetos con enfermedad pulmonar obstructiva crónica (EPOC)

A.3.1

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

A Study to Evaluate the Efficacy and Safety of Two Different Medicines to Treat COPD

Estudio para evaluar la eficacia y seguridad de dos diferentes medicamentos en el tratamiento del la EPOC.

A.4.1

Sponsor's protocol code number

ZEP117115

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	GlaxoSmithKline, 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	USP GlaxoSmithKline
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline Research & Development Limited
B.5.2	Functional name of contact point	GSK Clinical Support HelpDesk
B.5.3	Address:
B.5.3.1	Street Address	1-3 IronBridge Road, Stockley Park West
B.5.3.2	Town/ city	Uxbridge, Middlesex
B.5.3.3	Post code	UB11 1BT
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44(0)2089904466
B.5.5	Fax number	+44(0)2089904968
B.5.6	E-mail	GSKClinicalSupportHD@gsk.com

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	Umeclidinium/Vilanterol
D.3.2	Product code	GSK573719/GW642444
D.3.4	Pharmaceutical form	Inhalation powder, pre-dispensed
D.3.4.1	Specific paediatric formulation	No
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	Umeclidinium
D.3.9.2	Current sponsor code	GSK573719
D.3.9.3	Other descriptive name	4-[Hydroxy(diphenyl)methyl]-1-{2-[(phenylmethyl)oxy]ethyl}-1-azoniabicyclo[2.2.2]octane bromide
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	62.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VILANTEROL
D.3.9.1	CAS number	503068-34-6
D.3.9.2	Current sponsor code	GW642444
D.3.9.3	Other descriptive name	Triphenylacetic acid - 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1)
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	25
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	SPIRIVA®
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	SPIRIVA®
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
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	TIOTROPIUM BROMIDE
D.3.9.1	CAS number	139404-48-1
D.3.9.4	EV Substance Code	SUB11095MIG
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)	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
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
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

Chronic Obstructive Pulmonary Disease (COPD)

Enfermedad Pulmonar Obstructiva Crónica (EPOC)

E.1.1.1

Medical condition in easily understood language

Chronic Obstructive Pulmonary Disease (COPD)

Enfermedad Pulmonar Obstructiva Crónica (EPOC)

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	10009033
E.1.2	Term	Chronic obstructive pulmonary disease
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

The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 24 weeks for the treatment of subjects with COPD.

El objetivo primario es comparar la eficacia de UMEC/VI polvo para inhalación (62,5/25 µg una vez al día) con tiotropio (18 µg una vez al día) durante 24 semanas, para el tratamiento de sujetos con EPOC.

E.2.2

Secondary objectives of the trial

Secondary objectives are to compare effects of UMEC/VI Inhalation Powder (62.5 /25 mcg) once-daily with tiotropium (18 mcg) once-daily on safety over 24 weeks in subjects with COPD.

El objetivo secundario es comparar los efectos de UMEC/VI polvo para inhalación (62,5/25 µg una vez al día) con tiotropio (18 µg una vez al día) sobre la seguridad de sujetos con EPOC tratados durante 24 semanas.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Type of subject: Outpatient.
2. Informed Consent: A signed and dated written informed consent prior to study
participation.
3. Age: Subjects 40 years of age or older at Visit 1.
4. Gender: Male or female subjects.
A female is eligible to enter and participate in the study if she is of: Non-child bearing potential or Child bearing potential (see study Protocol for list of acceptable contraceptive methods, p22-23)
5. COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.
6. Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack- ears [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
7. Severity of Disease: A pre and post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a pre and post-albuterol/salbutamol FEV1 of <=70% of predicted normal values calculated using NHANES III reference equations at Visit 1.
8. Dyspnea: A score of >=2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Visit 1.

1. Tipo de sujeto: Ambulatorio.
2. Consentimiento informado: Se ha de obtener el consentimiento informado por escrito antes de la participación en el estudio.
3. Edad: Sujetos de 40 años de edad o mayores en la Visita 1.
4. Sexo: Hombres o mujeres.
Una mujer es elegible para participar en el estudio si: No es potencialmente fértil o Es potencialmente fértil (consultar en el Protocolo del estudio la lista de los métodos anticonceptivos aceptables).
5. Diagnóstico de EPOC: Historia clínica establecida de EPOC según la definición de la American Thoracic Society/European Respiratory Society [Celli, 2004].
6. Historia de fumador: Fumador de cigarrillos actual o exfumador de >=10 paquete-años [número de paquete años = (número de cigarrillos al día / 20) x número de años de fumador (por ejemplo, 20 cigarrillos al día durante 10 años o 10 cigarrillos al día durante 20 años)]. Los exfumadores se definen como aquellos que han dejado de fumar al menos 6 meses antes de la Visita 1.
Nota: El tabaco de pipa y/o el cigarro puro no se pueden utilizar para calcular la historia de paquete-años
7. Gravedad de la enfermedad: Cociente FEV1/CVF pre y post-salbutamol <0,70 y FEV1 pre y post-salbutamol <=70% del valor normal previsto calculado utilizando las ecuaciones del NHANES III en la Visita 1 [Hankinson, 1999; Hankinson, 2010].
8. Disnea: Una puntuación >=2 en la escala Modified Medical Research Council Dyspnea (mMRC) en la Visita 1.

E.4

Principal exclusion criteria

1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
2. Asthma: A current diagnosis of asthma.
3. Other Respiratory Disorders: Known ?-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension,
sarcoidosis, or interstitial lung disease.
4. Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that,
in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
5. Contraindications: A history of allergy or hypersensitivity to any
anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician
contraindicates study participation or use of an inhaled anticholinergic.
6. Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
7. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1).
8. 12-Lead ECG.
9. Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
10. Medications prior to Screening - see list of medication in study protocol p25)
11. Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., ?12 hours per day) is not exclusionary.
12. Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy.
13. Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
14. Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
15. Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study.
16. Previous use of study drug: Previous participation in DB2113360 or DB2113374.

1. Embarazo: Mujeres en estado de gestación o lactancia o que tengan planeado quedarse embarazadas durante el estudio.
2. Asma: Diagnóstico actual de asma.
3. Otras enfermedades respiratorias: Deficiencia de alfa-1 antitripsina conocida, infecciones pulmonares activas (como tuberculosis) y cáncer de pulmón son condiciones excluyentes absolutas. Un sujeto que, a juicio del investigador, tenga cualquier otra enfermedad respiratoria significativa además de la EPOC, debe ser excluido. Son ejemplos: bronquiectasias clínicamente significativas, hipertensión pulmonar, sarcoidosis o enfermedad pulmonar intersticial.
4. Otras enfermedades/anomalías: Sujetos con evidencia antigua o actual de anomalías clínicamente significativas cardiovasculares, neurológicas, psiquiátricas, renales, hepáticas, inmunológicas, endocrinas (incluidas la diabetes no controlada o la enfermedad tiroidea) o hematológicas que estén incontroladas y/o historia anterior de cáncer en remisión <5 años antes de la Visita 1 (el carcinoma cutáneo localizado que ha sido totalmente extirpado no es excluyente). Se considera significativa cualquier enfermedad que a juicio del investigador pondría en riesgo la seguridad del sujeto si participara en el estudio, o que afectaría al análisis de eficacia o seguridad si la enfermedad/anomalía se exacerbara durante el estudio.
5. Contraindicaciones: Historia de alergia o hipersensibilidad a cualquier antagonista de los receptores anticolinérgicos/muscarínicos, beta2-agonista, lactosa/proteínas de la leche o estearato de magnesio o una enfermedad, como el glaucoma de ángulo cerrado, la hipertrofia de próstata o la obstrucción del cuello de la vejiga, que a juicio del médico del estudio, contraindique la participación en el estudio o el empleo de anticolinérgicos inhalados.
6. Hospitalización: Hospitalización por EPOC o neumonía en las 12 semanas anteriores a la Visita 1.
7. Resección pulmonar: Sujetos sometidos a cirugía reductora del volumen pulmonar en los 12 meses anteriores a la Selección (Visita 1).
8. ECG de 12 derivaciones: Hallazgo ECG anormal y significativo en el ECG de 12 derivaciones realizado en la Visita 1, incluida la presencia de un ritmo marcado en un ECG de 12 derivaciones que haga que el ritmo subyacente y el ECG sean poco claros. Se proporcionarán a los investigadores revisiones realizadas por un cardiólogo independiente centralizado para ayudar en la evaluación de la elegibilidad del sujeto. Los hallazgos ECG que impiden la elegibilidad del sujeto se citan en el Apéndice 4. El investigador del estudio determinará el significado médico de cualquier otra anomalía ECG no citada en el Apéndice 4.
9. Medicación anterior a la espirometría: Sujeto incapaz de suspender el albuterol/ salbutamol durante el periodo de 4 horas previo a la espirometría en cada visita del estudio.
10. Medicaciones anteriores a la Selección: consultar la lista de mediación en el protocolo del estudio, página 24).
11. Oxígeno: Empleo de oxigenoterapia prolongada (LTOT) descrita como oxigenoterapia prescrita durante más de 12 horas al día. El empleo de oxígeno a demanda (<=12 horas al día) no es excluyente.
12. Terapia nebulizada: Empleo regular (prescrito para su uso todos los días, no a demanda) de broncodilatadores de acción corta (ej., albuterol/salbutamol) a través de terapia nebulizada.
13. Programa de rehabilitación pulmonar: Participación en la fase aguda de un programa de rehabilitación pulmonar en las 4 semanas anteriores a la Visita 1. Los sujetos que estén en la fase de mantenimiento de un programa de rehabilitación pulmonar no serán excluidos.
14. Abuso de alcohol o drogas: Historia conocida o sospecha de abuso de alcohol o drogas en los 2 años anteriores a la Visita 1.
15. Afiliación con el centro investigador: Investigador, subinvestigador, coordinador del estudio, empleado de un centro investigador participante o familiar directo de los anteriormente mencionados que participa en este estudio.
16. Utilización previa del fármaco en estudio: Participación previa en los estudios DB2113360 o DB2113374.

E.5 End points

E.5.1

Primary end point(s)

Clinic visit trough FEV1 on Treatment Day 169.
Trough FEV1 on Treatment Day 169 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 168 (i.e. at Week 24).

La variable primaria es el FEV1 valle medido en la visita a la clínica el Día de tratamiento 169. El FEV1 valle el Día de tratamiento 169 se define como la media de los valores de FEV1 obtenidos 23 y 24 horas después de la dosis el Día de tratamiento 168 (es decir, en la Semana 24).

E.5.1.1

Timepoint(s) of evaluation of this end point

serial spir performed pre-dose 15 and 30 minutes and 1 3 and 6 hours post dose. at visit 2 pre-dose will be performed 30 and 5 minutes. at visits 6 and 9 pre-dose will be 23 and 24 hours after the previous days dosing.

Se realizarán espirometrias seriadas antes de la dosis de la medicación y 15 min, 30 min y 1, 3 y 6 horas después de la dosis de la medicación. En la visita 2, se harán espirometrias a los 30 min y 5 min antes de la dosis de la medicación. En visita 2 y visita 9, se hará una espirometria pre-dosis a las 23 y 24 horas después de la dosis del día anterior.

E.5.2

Secondary end point(s)

Weighted mean 0-6 hour FEV1 obtained post-dose at Week 24.

Media ponderada del FEV1 de 0-6 horas obtenido después de la dosis en la Semana 24.

E.5.2.1

Timepoint(s) of evaluation of this end point

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

Yes

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

Yes

E.8.2.3.1

Comparator description

Tiotropium

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

Argentina

Canada

Russian Federation

Ukraine

United States

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

LSLV

Última visita del último sujeto.

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

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)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

450

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

450

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

Yes

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

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

490

F.4.2.2

In the whole clinical trial

900

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)

The investigator is responsible for ensuring that consideration has been given to the poststudy
care of the patient?s medical condition whether or not GSK is providing specific post study treatment.
GSK will not provide post-study treatment. Post-treatment COPD therapy should not be
entered into the eCRF except if for an exacerbation or adverse event.

El investigador es responsable de garantizar que el sujeto recibe los cuidados posteriores al estudio necesarios para su enfermedad independientemente de que GSK proporcione o no un tratamiento específico posterior al estudio.

GSK no proporcionará tratamiento posterior al estudio. El tratamiento posterior al estudio para la EPOC no se debe introducir en el CRDe, excepto si se administra para una exacerbación o acontecimiento adverso.

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

2013-01-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-14

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

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