Clinical Trials Register

Summary
EudraCT Number:	2010-021638-72
Sponsor's Protocol Code Number:	HZC113782
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-01-23
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2010-021638-72

A.3

Full title of the trial

A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease.

Studio sugli esiti clinici teso a valutare l`effetto di fluticasone furoato/vilanterol polvere per inalazione 100/25 mcg rispetto a placebo sulla sopravvivenza in soggetti con broncopneumopatia cronica ostruttiva (BPCO) moderata e storia o a rischio maggiore di malattia cardiovascolare.

A.3.1

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

Study to evaluate the effect of fluticasone furoate/vilanterol on survival in subjects with chronic obstructive pulmonary disease.

Studio per la valutazione l'effetto di fluticasone furoato/vilanterol sulla sopravvivenza dei soggetti con broncopneumopatia cronica ostruttiva.

A.3.2

Name or abbreviated title of the trial where available

HZ COPD Mortality Study

HZ COPD Studio di mortalita'

A.4.1

Sponsor's protocol code number

HZC113782

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01313676

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	GLAXO SMITH KLINE RESEARCH & DEVELOPMENT LTD
B.1.3.4	Country	United Kingdom
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	GlaxoSmithKline Research & Development Ltd
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 Ltd
B.5.2	Functional name of contact point	Clincial Trails Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	Iron Bridge Road, Stockley Park west
B.5.3.2	Town/ city	Uxbridge, Middlesex
B.5.3.3	Post code	UB11 - 1BU
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	0044 0208 990 44 66
B.5.5	Fax number	0044 0208 990 12 34
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	Fluticasone Furoate
D.3.2	Product code	GW685698X
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	FLUTICASONE FUROATE
D.3.9.1	CAS number	397864-44-7
D.3.9.2	Current sponsor code	GW685698X
D.3.9.3	Other descriptive name	Fluticasone Furoate
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	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	vilanterol trifenatate
D.3.9.1	CAS number	503070-58-4
D.3.9.2	Current sponsor code	GW642444M
D.3.9.3	Other descriptive name	vilanterol trifenatate
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	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	Fluticasone Furoate
D.3.2	Product code	GW685698X
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	FLUTICASONE FUROATE
D.3.9.1	CAS number	397864-44-7
D.3.9.2	Current sponsor code	GW685698X
D.3.9.3	Other descriptive name	Fluticasone Furoate
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	100
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	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	Vilanterol
D.3.2	Product code	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	vilanterol trifenatate
D.3.9.1	CAS number	503070-58-4
D.3.9.2	Current sponsor code	GW642444M
D.3.9.3	Other descriptive name	vilanterol trifenatate
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.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, pre-dispensed
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

Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD)

Soggetti con moderata broncopneumopatia cronica ostruttiva (BPCO)

E.1.1.1

Medical condition in easily understood language

Chronic bronchitis and emphysema

Bronchite cronica ed enfisema

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 of this study is to prospectively evaluate the effect of Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25mcg QD compared with placebo on survival in subjects with moderate COPD (≥50 and ≤70 % predicted FEV1) and a history of, or at increased risk for developing, cardiovascular disease.

L’obiettivo primario di questo studio è valutare in via prospettica l’effetto sulla sopravvivenza della combinazione Fluticasone Furoato (FF)/Vilanterol (VI) polvere per inalazione 100/25 mcg QD vs. placebo in soggetti con BPCO moderata (FEV1 >50 e <70 % del predetto) e storia di malattia cardiovascolare o esposti a un più alto rischio di malattia cardiovascolare.

E.2.2

Secondary objectives of the trial

• To evaluate the effect of FF/VI compared with placebo on the rate of decline in FEV1 • To evaluate the effect of FF/VI compared with placebo on a cardiovascular composite endpoint comprised of on-treatment CV death, myocardial infarction , stroke, unstable angina and TIA.

• valutare l’effetto di FF/VI vs. placebo sulla velocità di decremento del FEV1; • valutare l’effetto di FF/VI vs. placebo sull’endpoint cardiovascolare composito costituito da decesso per cause CV durante la terapia, infarto del miocardio, ictus, angina instabile e TIA.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Type of subject: outpatient. 2. Informed consent: Subjects must give their signed and dated written informed consent to participate. 3. Gender: Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception. 4. Age: ≥40 and ≤ 80 years of age at Screening (Visit 1). 5. Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. 6. Airflow Obstruction • Subjects with a measured post-albuterol/salbutamol FEV1 ≥50 and ≤70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1). Post-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated. 7. Dyspnea: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1) 8. Cardiovascular disease: For patients >= 40 years of age: any one of the following: Established (i.e. by clinical signs or imaging studies) coronary artery disease (CAD) Established (i.e. by clinical signs or imaging studies) peripheral vascular disease (PVD) Previous stroke Previous MI Diabetes mellitus with target organ disease OR For patients >=60 years of age: any 2 of the following: Being treated for hypercholesterolemia Being treated for hypertension Being treated for diabetes mellitus Being treated for peripheral vascular disease.

1. Tipologia di soggetti: pazienti. 2. Consenso Informato: i soggetti devono fornire il loro consenso scritto firmato e datato per poter partecipare. 3. Genere: uomini o donne. I soggetti di sesso femminile devono essere in post menopausa od utilizzare metodi contraccettivi di comprovata efficacia. La decisione di includere o escludere donne in età fertile è a discrezione del medico dello studio in accordo alla pratica clinica locale in relazione ad un adeguata contraccezione. 4. Età: ≥40 e ≤ 80 anni alla visita di Screening (Visita1). 5. Utilizzo di sigarette: i soggetti con una storia attuale o precedente di fumo di ≥10 pacchetti di sigarette all’anno alla visita di screening (Visita 1). Ex fumatori sono dfiniti coloro che hanno smesso di fumare almeno 6 mesi prima della visita 1. 6. Ostruzione delle vie aeree: •Soggetti che dopo la somministrazione di albuterolo/salbutamolo presentino valori di FEV1 ≥50 e ≤70% dei valori normali previsti calcolati con le equazioni di riferimento NHANES III [Hankinson, 1999; Hankinson, 2010] allo Screening (Visita 1). La spirometria post-broncodilatatore sarà eseguita circa 15 minuti dopo che il soggetto avrà assunto 4 inalazioni (ovvero, 400 mcg in totale) di albuterolo/salbutamolo mediante un inalatore spray predosato (MDI) dotato di distanziatore. Saranno calcolati il rapporto FEV1/FVC e i valori percentuali previsti di FEV1. 7. Dispnea: i soggetti devono ottenere un punteggio pari o superiore a 2 alla scala MRCD (Medical Research Council Dyspnea) modificata (Visita 1). 8. Malattie cardiovascolari: Per pazienti >=40 anni qualunque dei seguenti: comprovata (ad es. da sintomi clinici or studi radiografici) malattia dell’arteria coronarica (CAD), comprovata (ad es. da sintomi clinici or studi radiografici) malattia vascolare periferica (PVD), Precedente ictus, precedente infarto miocardico, diabete mellito con coinvolgimento degli organi target o per pazienti >=60 anni: qualunque dei seguenti: precedente trattamento per ipercolesterolemia, precedente trattamento per ipertensione, precedente trattamento per diabete mellito, precedente trattamento per malattia vascolare periferica.

E.4

Principal exclusion criteria

1. Pregnancy: Women who are pregnant or lactating. 2. Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD). 3. α1-antitrypsin deficiency: Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD. 4. Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. 5. Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant. 6. A moderate/severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable). 7. Current severe heart failure (New York Heart Association class IV). Subjects will also be excluded if they have a known ejection fraction of <30% or if they have an implantable cardioverter defibrillator (ICD). 8. Other diseases/abnormalities: Any life-threatening condition with life expectancy <3 years, other than vascular disease or COPD, that might prevent the subject from completing the study. 9. End stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal). 10. Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject’s participation will also be excluded. 11. Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years. 12. Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. ≤12 hours per day) is not exclusionary. 13. Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study or the potential compliance to study procedures. 14. Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study. 15. Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study (unless otherwise specified): view protocol page 23 for further information

1. Gravidanza: Donne che sono in gravidanza o allattamento. 2. Asma: soggetti con una diagnosi attuale di asma (soggetti con una storia precedente di asma sono eleggibili se hanno anche una diagnosi attuale di BPCO). 3. Insufficienza di α1-antitripsina: soggetti con conosciuta insufficienza di α1-antitripsina come causa basilare di BPCO. 4. Altri disturbi respiratori: soggetti con tubercolosi attiva, tumore polmonare, bronchiectasie, sarcoidosi, fibrosi polmonare, ipertensione polmonare, malattia interstiziale polmonare o altri disturbi polmonari attivi. 5. Resezione polmonare o trapianto: soggetti con riduzione chirurgica del volume polmonare nei 12 mesi precedenti allo Screening o che hanno ricevuto un trapianto di polmone. 6. Esacerbazione moderata/severa della BPCO che non sia stata risolta almeno entro 14 giorni dalla Visita 1 ed almeno 30 giorni dall’ultima dose di corticosteroidi orali (se applicabile). 7. Insufficienza cardiaca grave corrente (classe IV NYHA). I soggetti saranno inoltre esclusi se presentano una frazione d’eiezione nota <30% o se sono portatori di defibrillatore cardioverter impiantabile (ICD). 8. Altri disturbi/anomalie: qualunque condizione che metta in pericolo di vita con aspettativa <3 anni, diversa da malattie vascolari o BPCO, che può impedire al soggetto di completare lo studio. 9. Malattia renale cronica all’ultimo stadio: saranno esclusi soggetti che sono in dialisi (emodialisi o peritoneale). 10. Allergie a farmaci o ad alimenti: soggetti con precedente ipersensibilità a qualunque dei farmaci in studio (ed es. beta-agonisti, corticosteroidi) o componenti della polvere per inalazione (ad es. lattosio, magnesio stearato). Inoltre, saranno esclusi i pazienti con una storia di grave allergia alle proteine del latte che, secondo il medico, preclude la partecipazione allo studio. 11. Abuso di alcol o droghe: soggetti con storia, conosciuta o sospetta, di abuso di alcol o droghe negli ultimi 2 anni. 12. Terapia con ossigeno: soggetti in trattamento con terapia con ossigeno a lungo termine (LTOT) o terapia con ossigeno notturna richiesta per più di 12 ore al giorno. L'utilizzo di ossigeno (ad es. ≤12 ore al giorno) non esclude dalla partecipazione. 13. Discutibile validità del consenso: soggetti con malattie psichiatriche, invalidità mentale, poca motivazione od altre condizioni che limitano la validità del consenso informato alla partecipazione allo studio o la potenziale adesione alle procedure dello studio. 14. Affiliazione al centro sperimentale: Co-sperimentatori, study coordinator, dipendenti del centro o familiari degli sperimentatori sono esclusi dalla partecipazione a quasto studio. 15. Terapia farmacologica aggiuntiva: Uso dei seguenti farmaci entro gli intervalli sotto indicati prima della Visita 1 o durante lo studio (salvo diversa indicazione): si veda il Protocollo a pag. 23 per maggiori informazioni.

E.5 End points

E.5.1

Primary end point(s)

Primary Efficacy Endpoint • Time to death from any cause.

Endpoint di efficacia primaria • Tempo al decesso per qualsiasi causa.

E.5.1.1

Timepoint(s) of evaluation of this end point

Every 3 months for the duration of the study.

Ogni tre mesi per tutta la durata della sperimentazione.

E.5.2

Secondary end point(s)

Secondary Efficacy Endpoint • Rate of decline in FEV1 • Time to CV event.

Endpoint di efficacia secondaria • Velocità di decremento del FEV1 • Tempo all’evento CV.

E.5.2.1

Timepoint(s) of evaluation of this end point

rate of decline in FEV1 - only while on treatment. time to CV event - on and off treatment as we are doing for mortality.

Velocità di decremento del FEV1 solo durante il trattamento. Tempo all’evento CV durante e fuori dal trattamento come per la mortalità.

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

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

364

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

China

India

Indonesia

Japan

Korea, Republic of

Macedonia, the former Yugoslav Republic of

Philippines

Russian Federation

South Africa

Taiwan

Thailand

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

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

Number of subjects for this age range:

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:

11000

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

5000

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

4815

F.4.2.2

In the whole clinical trial

16000

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)

At the end of treatment with Investigational Product, subjects will be prescribed appropriate COPD therapy if required. There are no plans to provide the study medication for compassionate use following study completion.

Alla fine del trattamento con il farmaco sperimentale, se richiesto, sarà prescritta ai soggetti l'appropriata terapia per la BPCO. Non ci sono piani di fornitura dei farmaci sperimentali per uso compassionevole dopo la conclusione di questa sperimentazione.

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

2011-06-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-07-15

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IMP with orphan designation in the indication
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