Clinical Trials Register

Summary
EudraCT Number:	2015-000982-30
Sponsor's Protocol Code Number:	4993/15
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-08
Trial 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

2015-000982-30

A.3

Full title of the trial

Personalized pharmacological treatment of chronic obstructive pulmonary disease based on phenotyping: interventional study

Terapia farmacologica personalizzata in pazienti con broncopneumopatia cronica ostruttiva basata su fenotipizzazione: studio interventistico

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

4993/15

A.5.4

Other Identifiers

Name:

non disponibile

Number:

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	FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	FONDAZIONE ROMA
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	POLICLINICO A. GEMELLI
B.5.2	Functional name of contact point	UNITA' OPERATIVA COMPLESSA DI FARMA
B.5.3	Address:
B.5.3.1	Street Address	L.GO GEMELLI 8
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.4	Telephone number	0630156092
B.5.5	Fax number	0630156292
B.5.6	E-mail	pmontuschi@rm.unicatt.it

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	Yes
D.2.1.1.1	Trade name	SERETIDE - DISKUS 50/500 1 INALATORE 60 DOSI POLV PER INALAZ
D.2.1.1.2	Name of the Marketing Authorisation holder	GLAXOSMITHKLINE S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Seretide diskus 50/500
D.3.2	Product code	na
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.3.11 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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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	SEREVENT - 50 MCG POLVERE PER INALAZIONE INALATORE DA 60 DOSI
D.2.1.1.2	Name of the Marketing Authorisation holder	GLAXOSMITHKLINE S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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
D.3.2	Product code	na
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.3.11 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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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	Yes
D.2.1.1.1	Trade name	SPIRIVA - 30 CAPSULE IN BLISTER AL/PVC/AL DA 18 MCG CON DISPOSITIVO HANDIHALER
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	Italy
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 Handihaler
D.3.2	Product code	na
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.3.11 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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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

Chronic obstructive pulmonary disease (COPD)

Broncopneumopatia cronica ostruttiva (BPCO)

E.1.1.1

Medical condition in easily understood language

Pulmonary emphysema and chronic bronchitis

enfisema polmonare e bronchite cronica

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10070975
E.1.2	Term	Chronic obstructive bronchopneumopathy
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

1. Comparing the efficacy of ICS/LABA/LAMA vs LABA/LAMA in COPD patients with non-mixed phenotype (non-ACOS).

1. Comparare l¿efficacia della terapia con ICS/LABA/LAMA vs LABA/LAMA in pazienti BPCO con fenotipo non misto (non-ACOS).

E.2.2

Secondary objectives of the trial

1. Identifying molecular [gas chromatography/mass spectrometry (GC/MS), fraction of exhaled nitric oxide (FENO), electronic noses (e-noses), bacterial gene sequencing for airway microbiome identification], cellular (sputum analysis), imaging (chest multidetector row computed tomography, MDCT), biochemical [8-isoprostane and prostaglandin (PGE2) concentrations, both reported to be elevated in exhaled breath condensate (EBC) from COPD patients (17,18); PGE2 concentrations in sputum supernatants], and functional [including body plethysmography, forced oscillation technique (FOT), and single breath nitrogen washout] phenopypes, based on an innovative and validated platform, which is required for a better definition of non-mixed COPD phenotypes, for a more comprehensive consideration of the study covariates to be included in a pre-defined post-hoc analysis and, more importantly, for translating molecular phenotyping into a more personalized

1. Identificazione molecolare [gas cromatografia/spettrometria di massa (GC/MS), monossido di azoto nell¿aria espirata (FENO), naso elettronico (e-noses), sequenziamento genico batterico per l¿identificazione del microbioma delle vie aeree], cellulare (analisi dell¿espettorato), d¿immagine (chest multidetector row computed tomography MDCT), biochimica [concentrazione di 8-isoprostano e prostaglandine (PGE2), entrambe elevate nel condensato del respiro esalato (EBC) di pazienti con BPCO (17,18); concentrazione di PGE2 nel sovranatante dell¿espettorato] e funzionale [pletismografia, tecnica di oscillazione forzata (FOT), lavaggio con azoto a singolo respiro] fenotipi, basati su una piattaforma innovativa e validata, che ¿ richiesta per una migliore definizione di fenotipi BPCO non-misti, per una pi¿ globale considerazione dello studio covariato che include un¿analisi predefinita per la traslazione dei fenotipi molecolari in una terapia farmacologica maggiormente personalizzata

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, >60 and <85 years of age.
2. COPD (stage II-IV) based on GOLD guidelines with a FEV1/FVC < 70% and FEV1 <60% of the predicted value (6).
3. Reversibility to 400 µg equivalent of salbutamol <200 ml and <12% predicted value FEV1(6).
4. At least one COPD exacerbation in the previous year.
5. No acute exacerbations or upper respiratory tract infection in the previous 4 weeks.
6. No history of systemic disease or other pulmonary disease.
7. No ICS or systemic glucocorticoids in the previous 4 weeks.
8. No history of asthma or atopic disease.
9. Allowed treatment for COPD at visit 1: short-acting beta2-agonists alone as needed and LAMA and/or LABA on regular basis. If on different LAMA and/or LABA, at visit 1, patients will be shifted to study bronchodilators as described above.
10. Patients able to complete the study.
11. Ability to perform reproducible spirometry.
12. Patient is an ex smoker and has stopped smoking for at least 6 months.
13. Ability of patient to provide informed consent

1. Maschi o femmine, >60 e <85 anni di età.
2. COPD (stadio II-IV) basata su linee guida GOLD con FEV1/FVC <70% e FEV1 <60% del valore predetto (6).
3. Reversibilità a 400 µg di salbutamolo <200 ml e <12% del valore predetto di FEV1(6).
4. Almeno una riacutizzazione nell’anno precedente.
5. Nessuna riacutizzazione acuta o infezione delle vie aeree superiori nelle precedenti 4 settimane.
6. Nessuna storia di malattie sistemiche o altre malattie polmonari.
7. Nessuna terapia con ICS o glucocorticoidi sistemici nelle precedenti 4 settimane.
8. Nessuna storia di asma o malattie atopiche.
9. Terapia permessa ai pazienti in visita 1: SABA all’occorrenza e LAMA e/o LABA regolarmente. Se in terapia con differenti LAMA e/o LABA, alla visita 1 al paziente sarà cambiata la terapia come descritto sopra.
10. Il paziente deve essere in grado di completare lo studio.
11. Deve effettuare spirometrie riproducibili.
12. Il paziente deve essere un ex-fumatore, non fumatore da almeno 6 mesi.
13. Il paziente deve firmare il consenso informato prima di iniziare lo studio.

E.4

Principal exclusion criteria

1. Inability to provide informed consent
2. Patient is hospitalized
3. Major surgical procedure in the previous four weeks
4. Participation in a clinical trial in the previous four weeks
5. Patient is current smoker
6. No COPD exacerbation in the previous year.
7. Patient has been hospitalized for COPD in the previous two months.
8. Other respiratory diseases in addition to COPD
9. Glaucoma
10. Any illness that could be immediately life threatening.
11. Upper respiratory infections or exacerbations in the previous 4 weeks.

1. Il paziente non firma il consenso informato.
2. Il Paziente é ricoverato in ospedale.
3. Operazioni chirurgiche maggiori nei precedenti 4 mesi.
4. Ha partecipato ad uno studio clinico nelle precedenti 4 settimane.
5. Il paziente è attualmente fumatore.
6. Nessuna riacutizzazione nell’ultimo anno.
7. Paziente ricoverato per BPCO nei precedenti 2 mesi.
8. Altre patologie respiratorie oltre a BPCO
9. Glaucoma
10. Altre malattie che potrebbero provocare rischio di morte per il paziente.
11. Infezione delle vie aeree superiori o riacutizzazione nei precedenti 4 mesi.

E.5 End points

E.5.1

Primary end point(s)

Occurrence of 1) one moderate or severe COPD exacerbation during the 52-week treatment phase (V3-V6), or 2) one episode of decrease in trough FEV1 = 15% on the volume scale or = 10% on the predicted scale or = 200 ml during the 52-week treatment phase (V3-V6) compared with pre-bronchodilator FEV1 at pre-treatment visit (V2) (8). The occurrence and severity of COPD exacerbations will be defined based on GOLD guidelines (6).

1)Una moderata o severa riacutizzazione durante le 52 settimane di terapia (V3-V6), o 2) un episodio di diminuzione del FEV1 = 15% sulla scala del volume o = 10% sulla scala del predetto o = 200 ml durante le 52 settimane di terapia (V3-V6) comparata con pre-broncodilatatore FEV1 alla visita di pre-trattamento (V2) (8). La severità delle riacutizzazioni sarà definita sulla base delle linee guida GOLD (6).

E.5.1.1

Timepoint(s) of evaluation of this end point

52 weeks

52 settimane

E.5.2

Secondary end point(s)

Molecular:
1. E-Nose (Cyranose 320) sensor 1-32 resistance change
2. E-nose (Libranose) sensor 1-8 frequency change
3. Breath VOC concentrations identified and quantified by GC/MS
4. FENO
Functional:
1. pre- and post-bronchodilator FEV1
2. pre- and post-bronchodilator forced vital capacity (FVC)
3. pre- and post-bronchodilator FEV1/FVC
4. pre- and post-bronchodilator peak expiratory flow (PEF)
5. pre- and post-bronchodilator forced expiratory flow at 25%-75% of the FVC (FEF25%-75%)
6. pre- and post-bronchodilator total lung capacity (TLC)
7. pre- and post-bronchodilator airway resistance (Raw)
8. pre- and post-bronchodilator specific airway conductance (sGaw)
9. nitrogen (N2) difference 0.75-1.25 (slope of phase III of single breath N2 washout)
10. closing volume (CV) (phase IV of single breath N2 washout)
11. pre- and post-bronchodilator FOT parameters
Cellular
1. Neutrophil cell counts in sputum
2. Macrophage cell counts in sputum
3. Eosinophil cell counts in sputum
4. Lymphocyte cell counts in sputum
5.Total cell counts in sputum
Biochemical:
1. 8-Isoprostane concentrations in EBC
2. PGE2 concentrations in EBC
3. PGE2 concentrations in sputum
4. Urinary 8-isoprostane
Imaging
1. Airway lumen area (LA)
2. Percentage of airway wall area (WA%)
3. Airway wall thickness (WT)
4. Percentage of wall thickness (WT%)
5. Airway wall volume (WV)
6.10 mm lumenal perimeter (pi10) WA
7. percentage of volume index (VI%) < -950 HU for emphysema
8. VI% < -850 HU for air trapping
9. Mean lung density (MLD) expiration/inspiration (E/I)
10. VI -850 E-I (%)
11. Percentage of wall volume (WV%)
Patient reported outcome:
1. St. George Respiratory Questionnaire (SGRT)

Molecolare:
1. E-nose (Cyranose 320) sensori 1-32, cambio di resistenza.
2. E-nose (Libranose) sensori 1-8, cambio di frequenza.
3. Identificazione e quantificazione di composti volatili (VOCs) nel respiro dei pazienti mediante GC/MS.
4. FENO
Funzionale:
1. FEV1 pre e post-broncodilatatore
2. Capacit¿ vitale forzata (FVC) pre e post-broncodilatatore
3. FEV1/FVC pre e post broncodilatatore
4. Picco di flusso espiratorio (PEF) pre e post-broncodilatatore
5. Flusso espiratorio forzato al 25%-75% del FVC pre e post- broncodilatatore (FEF25%-75%)
6. Capacit¿ polmonare totale (TLC) pre e post-broncodilatatore
7. Resistenza delle vie aeree pre e post-broncodilatatore (Raw)
8. Conduttanza specifica delle vie aeree pre e post-broncodilatatore (sGaw)
9. Differenza N2 0,75-1,25 (pendenza di fase III del lavaggio con azoto a singolo respiro)
10. Volume di chiusura (CV) (fase IV del lavaggio con azoto a singolo respiro)
11. Parametri FOT pre e post-broncodilatatore
Cellulare:
1. Conta cellulare dei neutrofili nell¿espettorato indotto
2. Conta cellulare dei macrofagi nell¿espettorato indotto
3. Conta cellulare degli eosinofili nell¿espettorato indotto
4. Conta cellulare dei linfociti nell¿espettorato indotto
5. Conta cellulare totale nell¿espettorato indotto.
Biochimico:
1. Concentrazione dell¿8-isoprostano nel EBC
2. Concentrazione di PGE2 nel EBC
3. Concentrazione di PGE2 nell¿espettorato
4. 8-isoprostano urinario
Immagine:
1. Area del lume delle vie aeree (LA)
2. Percentuale di superficie della parete delle vie aeree (WA%)
3. Spessore della parete delle vie aeree (WT)
4. Percentuale di parete delle vie aeree (WT%)
5. Volume della parete delle vie aeree (WV)
6. Perimetro lumenale di 10 mm (pi10) WA
7. Percentuale di indice di volume (VI%) < -950 HU per enfisema
8. VI% < -850 HU per intrappolamento dell¿aria
9. Densit¿ media del polmone (MLD) espirazione/inspirazione (E/I)
10. VI -850 E-I (%)
11. Percentuale del volume di parete (WV%)
Outcome riportato dal paziente:
1. Questionario respiratorio St. George (SGRT)

E.5.2.1

Timepoint(s) of evaluation of this end point

52 weeks

52 settimane

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

118

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

168

F.4.2

For a multinational trial

F.4.2.1

In the EEA

168

F.4.2.2

In the whole clinical trial

168

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)

normal clinical practice

normale pratica clinica

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

2016-08-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-05-14

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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