Clinical Trials Register

Summary
EudraCT Number:	2016-002513-22
Sponsor's Protocol Code Number:	201749
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:	2017-01-25
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

2016-002513-22

A.3

Full title of the trial

A 24-week treatment, multi-center, randomized, double-blind, double-dummy, parallel group study to compare Umeclidinium/Vilanterol, Umeclidimium, and Salmeterol in subjects with chronic obstructive pulmonary disease (COPD).

Estudio multicéntrico, aleatorizado, doble ciego, con doble enmascaramiento, de grupos paralelos y 24 semanas de duración, para comparar umeclidinio/ vilanterol, umeclidinio y salmeterol 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

Clinical Research Study to compare Umeclidinium/Vilanterol, Umeclidimium, and Salmeterol in subjects with chronic obstructive pulmonary disease (COPD).

Estudio clínico para comparar umeclidinio/ vilanterol, umeclidinio y salmeterol en sujetos con enfermedad pulmonar obstructiva crónica (EPOC).

A.4.1

Sponsor's protocol code number

201749

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	GSK
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline
B.5.2	Functional name of contact point	Centro de Información
B.5.3	Address:
B.5.3.1	Street Address	C/Severo Ochoa, 2 (P.T.M.)
B.5.3.2	Town/ city	Tres Cantos (Madrid)
B.5.3.3	Post code	28760
B.5.3.4	Country	Spain
B.5.4	Telephone number	34902202700
B.5.5	Fax number	34918070479
B.5.6	E-mail	es-ci@gsk.com

D. IMP Identification
D.IMP: 1
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	Incruse
D.2.1.1.2	Name of the Marketing Authorisation holder	Glaxo Group Limited
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	umeclidinium bromide
D.3.2	Product code	GSK573719
D.3.4	Pharmaceutical form	Inhalation powder
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 BROMIDE
D.3.9.1	CAS number	869113-09-7
D.3.9.2	Current sponsor code	GSK573719
D.3.9.4	EV Substance Code	SUB119778
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.3.11 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	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	ANORO
D.2.1.1.2	Name of the Marketing Authorisation holder	Glaxo Group Limited
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	Anoro
D.3.2	Product code	GSK573719
D.3.4	Pharmaceutical form	Inhalation powder
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 BROMIDE
D.3.9.1	CAS number	869113-09-7
D.3.9.2	Current sponsor code	GSK573719
D.3.9.4	EV Substance Code	SUB119778
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	503070-58-4
D.3.9.3	Other descriptive name	VILANTEROL TRIFENATATE
D.3.9.4	EV Substance Code	SUB36527
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: 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	Serevent Accuhaler
D.2.1.1.2	Name of the Marketing Authorisation holder	Glaxo Wellcome UK Ltd
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	Serevent Accuhaler
D.3.4	Pharmaceutical form	Inhalation powder
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	SALMETEROL
D.3.9.1	CAS number	94749-08-3
D.3.9.3	Other descriptive name	SALMETEROL XINAFOATE
D.3.9.4	EV Substance Code	SUB04314MIG
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	50
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	19.1
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

To compare the effect of UMEC/VI (62.5/25 mcg once daily) with UMEC (62.5 mcg once daily) on lung function.

Comparar el efecto de UMEC/VI (62,5/25 μg una vez al día) con el de UMEC (62,5 μg una vez al día) sobre la función respiratoria.

E.2.2

Secondary objectives of the trial

To compare UMEC/VI (62.5/25 mcg once daily), UMEC (62.5 mcg once daily) with salmeterol (50 mcg twice daily) on patient reported outcomes (PROs).

Comparar el efecto de UMEC/VI (62,5/25 μg una vez al día), UMEC (62,5 μg una vez al día) y salmeterol (50 μg dos veces al día) sobre resultados de salud comunicados por los pacientes (PROs).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

AGE
1. 40 years or older at date of signing informed consent at Screening Visit 1.
TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
2. Outpatient with a diagnosis of COPD.
3. FEV1: Persistent airflow limitations as indicated by: A pre and postalbuterol/ salbutamol FEV1/FVC ratio of <0.70 and a post-albuterol/salbutamol FEV1 of ≥30% to ≤80% predicted normal values at Screening Visit 1.
4. CAT score: A CAT score of ≥10 at Screening Visit 1.

Smoking History
5. Current or former cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years [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 both equal 10 pack-years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack-year history.

SEX
6. Male and female subjects are eligible to participate in the study
A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies:
a. Non-reproductive potential defined as:
Pre-menopausal females with one of the following:
• Documented tubal ligation
• Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
• Hysterectomy
• Documented Bilateral Oophorectomy
Postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause must be tested. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study.
Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
b. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until [at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer] after the last dose of study medication and completion of the follow-up visit.

INFORMED CONSENT
7. Capable of giving signed informed consent prior to study participation, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

EDAD
1. 40 años o más de edad en la fecha de la firma del consentimiento informado, en la visita de selección.
TIPO DE SUJETO Y DIAGNÓSTICO, INCLUIDA LA GRAVEDAD DE LA ENFERMEDAD
2. Paciente ambulatorio con diagnóstico de EPOC según la definición de la American Thoracic Society/Sociedad Europea de Neumología (ATS/ERS) [Celli, 2004].
3. FEV1: obstrucción persistente del flujo aéreo indicado por: un cociente FEV1/FVC pre- y post-salbutamol < 0,70 y FEV1 post-salbutamol ≥ 30% y ≤ 80% de los valores normales teóricos en la visita 1. Los valores teóricos se basarán en la ‘Global Lung Function Initiative’ de la ERS [Quanjer, 2012].
4. Puntuación CAT: puntuación CAT ≥ 10 en la visita 1 (selección).
ANTECEDENTES DE TABAQUISMO.
5. Fumador activo o ex fumador con antecedentes de tabaquismo de ≥ 10 paquetes año [número de paquetes año = (número de cigarrillos al día / 20) x número de años de fumador (p. ej., 20 cigarrillos al día durante 10 años o 10 cigarrillos al día durante 20 años equivalen a 10 paquetes año)]. Los ex fumadores se definen como los sujetos que han dejado de fumar al menos 6 meses antes de la visita 1. El uso de pipas o de puros no puede utilizarse para calcular los antecedentes de paquetes año.
SEXO
6. En el estudio podrán participar varones y mujeres.
Las mujeres podrán participar en el estudio si no están embarazadas (confirmado con un resultado negativo de la prueba de gonadotropina coriónica humana (hCG) en orina) ni en período de lactancia, y si cumplen al menos una de las condiciones siguientes:
a. No tienen capacidad de procrear, definida como:
Situación premenopáusica con alguna de las circunstancias siguientes:
-Ligadura de trompas documentada.
-Procedimiento documentado de oclusión histeroscópica de trompas con confirmación de seguimiento de oclusión de trompas bilateral.
-Histerectomía.
-Ovariectomía bilateral documentada.
Situación posmenopáusica, definida como 12 meses de amenorrea espontánea. En los casos dudosos deberá analizarse una muestra de sangre con determinación simultánea de concentraciones de folitropina (FSH) y estradiol compatibles con menopausia. Las mujeres que estén recibiendo tratamiento hormonal sustitutivo (THS) y cuya situación menopáusica suscite dudas, tendrán que utilizar uno de los métodos anticonceptivos muy eficaces si desean continuar con el THS durante el estudio. De lo contrario, deberán interrumpir el THS para poder confirmar la situación posmenopáusica antes de su inclusión en el estudio.
b. Capacidad de procrear y compromiso de utilizar una de las opciones enumeradas en la Lista modificada de métodos anticonceptivos eficaces en mujeres en edad fértil (MEF) desde 30 días antes de la primera dosis de la medicación del estudio y hasta al menos cinco semividas terminales O hasta que haya finalizado cualquier efecto farmacológico continuado, lo que dure más tiempo, después de la última dosis de la medicación del estudio y la finalización de la visita de seguimiento.
El investigador será responsable de garantizar que los sujetos conozcan el modo correcto de empleo de estos métodos anticonceptivos.
CONSENTIMIENTO INFORMADO
7.Capacidad de otorgar el consentimiento informado firmado, lo que incluye el cumplimiento de los requisitos y restricciones mencionados en el documento de consentimiento y en este protocolo.

E.4

Principal exclusion criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER FUNCTION
1. Asthma
2. Alpha-antitrypsin deficiency
3. Other respiratory disorder
4. Unstable liver disease
5. Unstable or life threatening cardiac disease
6. 12 Lead ECG:
7. Antimuscarinic effects
8. Other disease abnormalities
9. Hospitalization
10. Inhaled corticosteroids (ICS)
11. Exacerbation
12. Other respiratory tract infections
13. Lung Resection
14. Oxygen
(For detailed list, please refer to pages 27-29 of the study protocol)

CONCOMITANT MEDICATIONS
1. Medications prior to Screening: Use of the following medications according to the following defined time intervals prior to Screening (Visit 1) (Please refer to table listed on page 29 of study protocol)
2. Medication prior to spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
3. Maintenance use of short-acting bronchodilators: Regular use (prescribed for daily/ regular use, not for as-needed use) of short-acting bronchodilators (e.g. albuterol/salbutamol).

RELEVANT HABITS
1. Drug or alcohol abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Screening Visit 1 that in the opinion of the investigator would prevent the subject from completing the study procedures.

CONTRAINDICATIONS
1. Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, sympathomimetic, lactose/milk protein or magnesium stearate.

DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA
1. Pulmonary Rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
2. Affiliation with investigator sites: 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
3. Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete questionnaires on the electronic diary.

Subjects who fail to meet inclusion and exclusion criteria at the Screening Visit 1 will be considered screen failures and cannot be re-screened.

ENFERMEDADES CONCURRENTES/ANTECEDENTES MÉDICOS (INCLUIDA FUNCIÓN HEPÁTICA)
1. Asma
2. Carencia de α1 antitripsina
3. Otros trastornos respiratorios
4. Hepatopatía inestable
5. Cardiopatía inestable o potencialmente mortal
6. ECG de 12 derivaciones
7. Efectos antimuscarínicos
8. Otras enfermedades o anomalías
9. Hospitalización
10. Corticoides inhalados
11. Exacerbaciones
12. Otras infecciones de las vías respiratorias
13. Resección pulmonar
14. Oxígeno
(Para una lista detallada, ver Sección 5.2del Protocolo )
MEDICAMENTOS CONCOMITANTES
1. Medicamentos antes de la selección: Uso de los siguientes medicamentos conforme a los siguientes intervalos definidos, antes de la selección (visita 1):
2. Medicación antes de la espirometría: imposibilidad de suspender el uso de salbutamol durante el período de 4 horas exigido antes de la espirometría en cada visita del estudio.
3. Uso de mantenimiento de broncodilatadores de acción corta: uso regular (prescritos para uso diario y regular, no para uso a demanda) de broncodilatadores de acción corta (p. ej., salbutamol).
HÁBITOS RELEVANTES
1. Abuso de drogas o alcohol: antecedentes conocidos o presuntos de alcoholismo o toxicomanía en los 2 años previos a la visita 1 de selección que, en opinión del investigador, impidan que el sujeto complete los procedimientos del estudio.
CONTRAINDICACIONES
1. Cualquier antecedente de alergia o hipersensibilidad a anticolinérgicos o antagonistas de receptores muscarínicos, simpaticomiméticos, lactosa/proteínas de la leche o estearato de magnesio.
EVALUACIONES DIAGNÓSTICAS Y OTROS CRITERIOS
1. Programa de rehabilitación pulmonar: participación en la fase inicial de un programa de rehabilitación pulmonar en las 4 semanas previas a la visita 1 (selección). No se excluirá a los sujetos que se encuentren en la fase de mantenimiento de un programa de rehabilitación pulmonar.
2. Relación con el centro de investigación: se trata de un investigador, subinvestigador, coordinador del estudio o empleado de un centro participante de investigación o del estudio o un familiar inmediato del participante mencionado anteriormente que interviene en este estudio.
3. Incapacidad para leer: cualquier sujeto que, en opinión del investigador, no sepa leer o no pueda rellenar un cuestionario en el diario electrónico.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in trough Forced Expiratory Volume in One Second (FEV1) at week 24

Variación del FEV1 en la semana 24 con respecto al valor basal

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks post treatment

24 semanas después del tratamiento

E.5.2

Secondary end point(s)

To compare UMEC/VI (62.5/25 mcg once daily), UMEC (62.5 mcg once daily) with salmeterol (50 mcg twice daily) on patient reported outcomes (PROs)

Comparar el efecto de UMEC/VI (62,5/25 μg una vez al día), UMEC (62,5 μg una vez al día) y salmeterol (50 μg dos veces al día) sobre resultados de salud comunicados por los pacientes (PROs).

E.5.2.1

Timepoint(s) of evaluation of this end point

over 24 weeks of treatment

durante las 24 semanas del tratamiento

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)

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

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Salmeterol (Serevent) & Umeclidinum (UMEC) (Incruse)

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

100

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

Australia

Canada

Mexico

South Africa

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

LVLS

última visita del último paciente

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:

1818

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

606

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

1007

F.4.2.2

In the whole clinical trial

2424

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)

Subjects will not receive any additional treatment from GSK after completion of the study, since the study treatments are commercially available.
The investigator is responsible for ensuring that consideration has been given to the poststudy care of the subject’s medical condition, post-study treatment.

Los sujetos no recibirán más tratamiento de GSK tras la finalización del estudio porque los tratamientos del estudio se encuentran comercializados.
El investigador será responsable de garantizar que se tenga en cuenta la asistencia adecuada del sujeto después del estudio, una vez finalizado el tratamiento del estudio.

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

2017-03-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-02-20

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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