Clinical Trials Register

Summary
EudraCT Number:	2014-005671-92
Sponsor's Protocol Code Number:	PT010005
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:	2015-10-05
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

2014-005671-92

A.3

Full title of the trial

A Randomized, Double Blind, Multi Center, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52 Week Treatment Period in Subjects With Moderate to Very Severe COPD

Estudio aleatorizado, doble ciego, multicéntrico y de grupos paralelos para evaluar la eficacia y seguridad de PT010 en comparación con PT003 y PT009 para las exacerbaciones de la EPOC durante un período de tratamiento de 52 semanas en pacientes con EPOC de moderada a muy grave

A.3.1

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

Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations in Subjects With Moderate to Very Severe COPD

Estudio para evaluar la eficacia y seguridad de PT010 en comparación con PT003 y PT009 para las exacerbaciones de la EPOC en pacientes con EPOC de moderada a muy grave

A.4.1

Sponsor's protocol code number

PT010005

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02465567

A.5.4

Other Identifiers

Name:

US IND Number

Number:

118313

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	Pearl Therapeutics, Inc.
B.1.3.4	Country	United States
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	Pearl Therapeutics, Inc.
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	Pearl Therapeutics, Inc.
B.5.2	Functional name of contact point	Shannon Strom, PhD, RAC.Dir. RegAff
B.5.3	Address:
B.5.3.1	Street Address	4222 Emperor Blvd., Suite 560
B.5.3.2	Town/ city	Durham
B.5.3.3	Post code	NC 27703
B.5.3.4	Country	United States
B.5.4	Telephone number	+34914322630
B.5.5	Fax number	....
B.5.6	E-mail	sstrom@pearltherapeutics.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	Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI)
D.3.2	Product code	PT010
D.3.4	Pharmaceutical form	Pressurised inhalation, suspension
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	GLYCOPYRRONIUM BROMIDE
D.3.9.1	CAS number	596-51-0
D.3.9.3	Other descriptive name	Glycopyrronium, Glycopyrrolate
D.3.9.4	EV Substance Code	SUB07951MIG
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	7.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FORMOTEROL FUMARATE
D.3.9.1	CAS number	43229-80-7
D.3.9.3	Other descriptive name	Formoterol Fumarate Dihydrate
D.3.9.4	EV Substance Code	SUB02257MIG
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	4.8
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	51333-22-3
D.3.9.4	EV Substance Code	SUB05955MIG
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	80
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	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	Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI)
D.3.2	Product code	PT010
D.3.4	Pharmaceutical form	Pressurised inhalation, suspension
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	GLYCOPYRRONIUM BROMIDE
D.3.9.1	CAS number	596-51-0
D.3.9.3	Other descriptive name	Glycopyrronium, Glycopyrrolate
D.3.9.4	EV Substance Code	SUB07951MIG
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	7.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FORMOTEROL FUMARATE
D.3.9.1	CAS number	43229-80-7
D.3.9.3	Other descriptive name	Formoterol Fumarate Dihydrate
D.3.9.4	EV Substance Code	SUB02257MIG
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	4.8
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	51333-22-3
D.3.9.4	EV Substance Code	SUB05955MIG
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.3.11 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	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	Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
D.3.2	Product code	PT003
D.3.4	Pharmaceutical form	Pressurised inhalation, suspension
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	GLYCOPYRRONIUM BROMIDE
D.3.9.1	CAS number	596-51-0
D.3.9.3	Other descriptive name	Glycopyrronium, Glycopyrrolate
D.3.9.4	EV Substance Code	SUB07951MIG
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	7.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FORMOTEROL FUMARATE
D.3.9.1	CAS number	43229-80-7
D.3.9.3	Other descriptive name	Formoterol Fumarate Dihydrate
D.3.9.4	EV Substance Code	SUB02257MIG
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	4.8
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: 4
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	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	Budesonide and Formoterol Fumarate Metered Dose Inhaler (BFF MDI)
D.3.2	Product code	PT009
D.3.4	Pharmaceutical form	Pressurised inhalation, suspension
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	FORMOTEROL FUMARATE
D.3.9.1	CAS number	43229-80-7
D.3.9.3	Other descriptive name	Formoterol Fumarate Dihydrate
D.3.9.4	EV Substance Code	SUB02257MIG
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	4.8
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	51333-22-3
D.3.9.4	EV Substance Code	SUB05955MIG
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.3.11 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

Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Enfermedad Pulmonar Obstructiva Crónica (EPOC) de moderada a muy grave

E.1.1.1

Medical condition in easily understood language

Moderate to Very Severe COPD

EPOC de moderada a muy grave

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	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10010952
E.1.2	Term	COPD
E.1.2	System Organ Class	100000004855

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10010953
E.1.2	Term	COPD exacerbation
E.1.2	System Organ Class	100000004855

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 assess the effect of BGF MDI relative to GFF MDI and BFF MDI on the rate of moderate or severe COPD exacerbation.

Evaluar el efecto de BGF en IDP en comparación con GFF en IDP y BFF en IDP sobre la tasa de exacerbaciones moderadas o graves de la enfermedad pulmonar obstructiva crónica (EPOC)

E.2.2

Secondary objectives of the trial

-To assess the effect of BGF MDI relative to GFF MDI and BFF MDI on symptoms of COPD
-To assess the effect of BGF MDI relative to GFF MDI and BFF MDI on quality of life
-To assess the effect of BGF MDI relative to GFF MDI and BFF MDI on all-cause mortality

- Evaluar el efecto de BGF en IDP en comparación con GFF en IDP y BFF en IDP sobre los síntomas de la EPOC
- Evaluar el efecto de BGF en IDP en comparación con GFF en IDP y BFF en IDP sobre la calidad de vida
- Evaluar el efecto de BGF en IDP en comparación con GFF en IDP y BFF en IDP sobre la mortalidad por cualquier causa

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

2 sub studies are included in the protocol:
1) 4-Hour Pulmonary Function Test Sub-study: Serial PFTs will be conducted over 4 hours in a subset of approximately 3,060 subjects (765 subjects per treatment group) at selected visits throughout the 52-week Treatment Period.
2) 24-Hour Holter Monitoring Sub-study: Holter Monitoring will be conducted over 24 hours in a subset of approximately 800 randomized (200 subjects from each treatment group) at Visit 3 (Holter Baseline) and Visit 8 (Week 16).
The objectives are:
4 Hour Pulmonary Function Test (PFT) Sub-study Objective:
- To assess the effects of BGF MDI relative to GFF MDI and BFF MDI on lung function
24-Hour Holter Monitoring Sub-study Objective:
- To assess the cardiovascular safety of BGF MDI relative to GFF MDI and BFF MDI as evaluated by 24-hour Holter monitoring

Se incluyen 2 subestudios en el protocolo:
- Subestudio de pruebas de función pulmonar (PFP) de 4 horas: se realizarán pruebas de función pulmonar (PFP) durante 4 horas en un subgrupo de aproximadamente 3.060 pacientes (765 pacientes por grupo de tratamiento) en visitas seleccionadas a lo largo de la fase de tratamiento de 52 semanas.

- Subestudio de monitorización Holter de 24 horas: sSe realizará una monitorización Holter a lo largo de 24 horas en un subgrupo de aproximadamente 800 pacientes aleatorizados (200 pacientes de cada grupo de tratamiento) en la visita 3 (valor inicial del Holter) y en la visita 8 (semana 16).

Los objetivos son:
- Subestudio de pruebas de función pulmonar (PFP) de 4 horas: Evaluar el efecto de BGF en IDP en comparación con GFF en IDP y BFF en IDP sobre la función pulmonar
- Subestudio de monitorización Holter de 24 horas: Evaluar la seguridad cardiovascular de BGF en IDP en comparación con GFF en IDP y BFF en IDP según evaluación mediante monitorización Holter de 24 horas

E.3

Principal inclusion criteria

- Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS).
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio of <0.70 and FEV1 of <65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
- Subjects with history of exacerbations.

Please refer to the study protocol for the complete inclusion criteria list.

- Mujer no potencialmente fértil (esto es, es fisiológicamente incapaz de quedarse embarazada, lo que incluye a las mujeres que sean posmenopáusicas desde 2 años antes); or mujer potencialmente fértil con resultado negativo de una prueba de embarazo en suero en la visita 1 y que acepta la utilización de métodos anticonceptivos aceptables de forma continua y correcta durante todo el estudio.
- Pacientes con antecedentes clínicos documentados de EPOC, según la definición de la Sociedad Americana del Tórax (American Thoracic Society, ATS)/Sociedad Europea de Aparato Respiratorio (European Respiratory Society, ERS).
- Fumadores actuales o exfumadores con un historial de haber fumado como mínimo 10 paquetes-años.
- Cociente VEF1/CVF debe ser < 0,70, y el VEF1 debe ser < 65 % del valor normal previsto calculado con las ecuaciones de referencia NHANES III (o normas de referencia aplicables a otras zonas geográficas).
- Antecedentes de exacerbaciones.

Por favor, refiéranse al protocolo para el listado completo de criterios de inclusión.

E.4

Principal exclusion criteria

- Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
- Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
- Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
- Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
- Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
- Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.
- Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
- Subjects who have a history of hypersensitivity to ?2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.

Please refer to the study protocol for the complete exclusion criteria list.

- Enfermedades o patologías significativas distintas de la EPOC que, en opinión del investigador, pudieran poner en riesgo al paciente debido a su participación en el estudio o influir sobre los resultados del estudio o la capacidad del paciente para participar en el estudio.
- Las mujeres que estén embarazadas o en período de lactancia, o que tengan previsto quedarse embarazadas en el curso del estudio, o las mujeres potencialmente fértiles que no utilicen un método anticonceptivo aceptable.
- Pacientes que, en opinión del investigador, tengan un diagnóstico actual de asma.
- Pacientes que hayan sido hospitalizados a causa de una EPOC mal controlada en los 3 meses anteriores a la visita 1 (selección) o durante la fase de selección (visita 1 a visita 4).
- Pacientes que presenten una EPOC mal controlada, definida como un empeoramiento agudo de la EPOC que requiere tratamiento con corticosteroides o antibióticos orales en las 6 semanas anteriores a la visita 1 (selección) o durante la fase de selección (visita 1 a visita 4).
- Inmunosupresión (VIH), trastornos neurológicos graves que afecten el control de las vías respiratorias superiores u otros factores de riesgo que en opinión del investigador supondrían para el paciente un riesgo considerable de neumonía.
- Pacientes con un diagnóstico de glaucoma con ángulo estrecho que, en opinión del investigador, no hayan recibido un tratamiento adecuado.
- Pacientes que tengan antecedentes de hipersensibilidad a los agonistas ?2, a budesónida o a cualquier otro componente corticosteroideo, a glicopirronio u otros anticolinérgicos muscarínicos, o a cualquier componente del IDP o del inhalador de polvo seco (IPS).

Por favor, refiéranse al protocolo para el listado completo de criterios de exclusión.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is:
? The rate of moderate or severe COPD exacerbations

Criterio de valoración principal de la eficacia:
? Tasa de exacerbaciones moderadas o graves de la EPOC

E.5.1.1

Timepoint(s) of evaluation of this end point

Timepoint is listed with the endpoint.

El momento de evaluación está listada en la variable principal.

E.5.2

Secondary end point(s)

- Time to first moderate or severe COPD exacerbation
- Change from baseline in average daily rescue Ventolin HFA use over 52 weeks
- Transition Dyspnea Index (TDI) focal score over 24 weeks
- Change from baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) total score over 52 weeks
- Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score over 52 weeks
- Time to death (all cause)

- Tiempo hasta la primera exacerbación moderada o grave de la EPOC
- Cambio respecto al valor inicial en el uso promedio diario de Ventolin HFA de rescate a lo largo de 52 semanas
- Puntuación focal del índice de disnea de transición (IDT) a lo largo de 24 semanas
- Cambio respecto al valor inicial en la puntuación total del cuestionario de exacerbaciones de la enfermedad pulmonar crónica (Exacerbations of Chronic Pulmonary Disease Tool, EXACT) a lo largo de 52 semanas
- Cambio respecto al valor inicial en la puntuación total del Cuestionario Respiratorio de St. George (St. George?s Respiratory Questionnaire, SGRQ) en la semana 52 (EE. UU.) y a lo largo de 52 semanas
- Tiempo hasta la muerte (todas las causas)

E.5.2.1

Timepoint(s) of evaluation of this end point

Timepoint is listed with the endpoint.

El momento de evaluación está listada en las variables secundarias.

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

Yes

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

Yes

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

PR1 y PR2 se evalúan en comparación con PR3 (PT003) and PR4 (PT009)

PR1 and PR2 are tested against PR3 (PT003) and PR4 (PT009)

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

256

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

Australia

Austria

Belgium

Brazil

Canada

Chile

China

Czech Republic

France

Germany

Hungary

Italy

Japan

Korea, Republic of

Netherlands

New Zealand

Peru

Poland

Russian Federation

Serbia

South Africa

Spain

Sweden

Taiwan

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

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:

4400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

3600

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

220

F.4.2

For a multinational trial

F.4.2.1

In the EEA

2500

F.4.2.2

In the whole clinical trial

8000

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 be followed up through a TC at least 14 days after the last study drug dosing. The following information will be requested:
- Collect HCRU information.
- Review previously on going COPD exacerbations and AEs and record AEs (if any).
- Review concomitant medications.
During Visit 14, subjects will be returned to pre-study or appropriate COPD medications. There are no further formal plans for treatment or care after the subject has completed the study for the time being.

Se realizará un seguimiento de los pacientes mediante una TF como mínimo 14 días tras la última administración del fármaco de estudio. Se solicitará la siguiente información:
- Recoger información relativa a URS
- Revisar las exacerbaciones de la EPOC y los AA previamente en curso y registrar los AA (si los hay)
- medicacións simultánea

Durante la visita 14, devolver al paciente a sus medicamentos anteriores al estudio o a la adecuada medicación de mantenimiento para la EPOC

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

2015-10-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-07-26

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Orphan Designation Number:
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