Clinical Trials Register

Summary
EudraCT Number:	2014-002151-26
Sponsor's Protocol Code Number:	Z7200K02
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-07-24
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2014-002151-26

A.3

Full title of the trial

A Double Blind, Double Dummy, Randomized, Two Way Cross-Over Study To Compare The Effects Of Z7200 And Symbicort® Turbohaler On Functional Respiratory Imaging Parameters In Asthmatic Patients

Dubbelblinde, dubbel dummy, gerandomiseerde, twee weg cross-over studie om de effecten van Z7200 en Symbicort® Turbohaler te vergelijken op functionele respiratoire beeldvorming parameters bij astmapatiënten.

A.3.1

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

Study to compare the effects of Z7200 And Symbicort® Turbohaler on respiratory imaging parameters in asthmatic patients.

Studie om de effecten vanZ7200 en Symbicort® Turbohaler te vergelijken op respiratoire beeldvorming parameters bij
astmapatiënten.

A.4.1

Sponsor's protocol code number

Z7200K02

A.5.4

Other Identifiers

Name:

CRO protocol code number

Number:

FLUI-2014-125

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	Zambon Spa
B.1.3.4	Country	Italy
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	Zambon Spa
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	Fluidda nv
B.5.2	Functional name of contact point	Jan De Backer
B.5.3	Address:
B.5.3.1	Street Address	Groeningenlei 132
B.5.3.2	Town/ city	Kontich
B.5.3.3	Post code	2550
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+3234508720
B.5.5	Fax number	+3234508729
B.5.6	E-mail	jan.debacker@fluidda.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	Symbicort® Turbohaler® 200 micrograms/6 micrograms/inhalation, inhalation powder.
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca UK Limited
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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.3.4	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	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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FORMOTEROL FUMARATE DIHYDRATE
D.3.9.1	CAS number	183814-30-4
D.3.9.3	Other descriptive name	FORMOTEROL FUMARATE DIHYDRATE
D.3.9.4	EV Substance Code	SUB25660
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	4.5
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	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	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	Z7200 inhalation powder
D.3.4	Pharmaceutical form	Inhalation powder, hard capsule
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	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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FORMOTEROL FUMARATE DIHYDRATE
D.3.9.1	CAS number	183814-30-4
D.3.9.3	Other descriptive name	FORMOTEROL FUMARATE DIHYDRATE
D.3.9.4	EV Substance Code	SUB25660
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	2.25
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	Yes
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, hard capsule
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

Asthma

Astma

E.1.1.1

Medical condition in easily understood language

Asthma is characterized by episodes of wheezing, breathlessness, chest
tightness, coughing. Hypersensitivity to stimuli, narrowing and chronic
inflammation of the airways.

Astma wordt gekenmerkt door episodes van piepen, kortademigheid,
druk op de borst, hoesten. Overgevoeligheid voor prikkels, vernauwing
en een chronische ontstekingsreactie van de luchtwegen.

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	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10049106
E.1.2	Term	Asthma chronic
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10003565
E.1.2	Term	Asthmatic
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10003555
E.1.2	Term	Asthma bronchial
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 evaluate the effect of the
products under investigation on Functional respiratory imaging
parameters and evaluate the particle deposition with Computational fluid dynamics (CFD).

Het primaire doel van deze studie is om het effect van de
onderzoeksproducten te evalueren op parameters bekomen met behulp
van functionele respiratoire beeldvorming en de depositie van deeltjes
met computationele stromingsdynamica (CFD) te evalueren.

E.2.2

Secondary objectives of the trial

The secondary objectives of this study are to assess the effect of
Z7200 and Symbicort® on lung function (spirometry and body plethysmography), on exercise capacity (6MWT)and on dyspnea (Borg CR10 Scale and VAS dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated through monitoring of adverse events throughout the study

De secundaire doelstellingen van dit onderzoek zijn om het effect van
Z7200 enSymbicort® op de longfunctie (spirometrie en plethysmografie) te beoordelen, op de inspanningscapaciteit (6MWT) en op dyspnoe (Borg CR10 Schaal en VAS dyspnoe). Bovendien zal de veiligheid van de twee onderzochte producten worden geëvalueerd door het opvolgen van bijwerkingen gedurende het onderzoek.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patient ≥ 18 years old.
2. Written informed consent obtained.
3. Patient with a documented diagnosis of asthma according to the
Global Initiative for Asthma (GINA) guidelines
4. Patient with a co-operative attitude and ability to correctly use the DPI.
5. Female patient of childbearing potential who confirm that a reliable method of contraception was used at least 14 days before visit 1 and will continue to use a reliable method of contraception during the study, or post-menopausal women (at least 12 months of amenorrhea)
6. Patient must be stable and treated in accordance with the GINA guidelines.
7. Patient must be a non-smoker or ex-smoker who have stopped smoking at least 1 month prior to visit 1 and has a smoking history of < 10 pack years.
8. Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.

1. Man of vrouw patiënt ≥ 18 jaar oud
2. Geschreven toestemming verkregen
3. Patiënt met een gedocumenteerde diagnose van astma volgens de
`Global Initiative for Asthma` (GINA) richtlijnen
4. Patiënt met een coöperatieve houding en in de mogelijkheid tot
training correct gebruik van DPI
5. Vrouwelijke patiënt in de mogelijkheid om kinderen te krijgen die
bevestigt dat een anticonceptie methode werd gebruikt ten minste 14
dagen voor bezoek 1 en blijft een anticonceptie methode te gebruiken
gedurende de studie, of postmenopauzale vrouwen (ten minste 12 maanden van amenorroe)
6. Patiënt moet stabiel zijn en behandeld in overeenstemming met de
GINA richtlijnen
7. Patiënt moet een niet-roker of ex-roker zijn die minstens 1 jaar
gestopt is met roken voorafgaand aan bezoek 1 en een rookgeschiedenis heeft van <10 pakjaren
8. Patiënt moet in staat zijn om de studie procedures, instructies,
vragenlijsten en restricties te begrijpen en na te leven

E.4

Principal exclusion criteria

1. Pregnant or lactating female.
2. Unstable patient who developed an asthma exacerbation in the 4 weeks before screening.
3. Patient with upper or lower airways infection in the 4 weeks before screening.
4. Patient unable to perform pulmonary function testing.
5. Patients unable to withdraw fixed combination or long acting bronchodilator inhalation products
6. Patient with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
7. Patient with active lung cancer or any other chronic disease with poor prognosis and /or affecting patient status.
8. Patient with allergy, sensitivity or intolerance to study drugs and/ or study drug formulation ingredients.
9. Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
10. Patient who received systemic corticosteroids within the last 4 weeks prior to visit
11. Patient who received any investigational new drug within the last 4 weeks prior to visit 1 and is participating in any clinical trial.
12. Patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
13. Patient with diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
14. Patients who has a lactose intolerance or history of allergy to milk proteins.
15. Patients treated with medications or herbal medicines that are strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, indinavir, nelfinavir, saquinavir, atazanavir, ketoconazole, itraconazole, voriconazole, fluconazole, cyclosporine, mibefradil, nefazodone, clarithromycin, telithromycin, troleandromycin, norfloxacin, ciprofloxacin) or inducers (e.g. phenobarbital, phenytoin, barbiturates, carbamazepine, oxcarbazepine, rifabutin, rifampin, St John’s wort) within 2 weeks prior to Screening Visit and during the study.

1. Zwangere vrouwen of vrouwen die borstvoeding geven
2. Instabiele patiënt die een exacerbatie heeft ontwikkeld tijdens de
laatste 4 weken
3. Patiënt met bovenste of onderste luchtwegen infectie in de 4 weken voor screening
4. Patiënt niet in staat om longfunctietesten uit te voeren
5. Patiënt niet in staat om te stoppen met vaste combinatie of langwerkende bronchodilator inhalatieproducten
6. Patiënt met een ongecontroleerde ziekte of een aandoening dat de
patiënt, naar het oordeel van de onderzoeker, kan blootstellen aan
onnodig risico of mogelijks de resultaten of de interpretatie van de
studie kan compromitteren
7. Patiënt met actieve longkanker of een andere chronische aandoening met een slechte prognose en / of aantasting van de toestand van de patiënt
8. Patiënt met allergie, gevoeligheid of intolerantie voor de
onderzoeksmedicatie en / of bestanddelen van de onderzoeksmedicatie
9. Patiënt die zich waarschijnlijk niet kan houden aan het protocol of niet in staat om de aard, omvang en de mogelijke gevolgen van het
onderzoek te begrijpen
10. Patiënt die systemic corticosteroïden kreeg in de laatste 4 weken
voorafgaand aan bezoek 1
11. Patiënt die een experimenteel nieuw geneesmiddel heeft ontvangen in de 4 weken voorafgaand aan visite 1 en neemt deel aan een klinische studie.
12. Patiënt met geschiedenis van alcohol of drugsmisbruik, dat naar het oordeel van de onderzoeker van klinische betekenis kan zijn
13. Patiënt met diagnose van COPD
14. Patiënt met een lactose-intolerantie of een voorgeschiedenis van allergie voor melkeiwitten
15. Patiënt heeft in de 2 weken voorafgaand aan visite 1 of tijdens de studie medicijnen of kruidenmiddelen ontvangen die sterke cytochroom P450 3A4 (CYP3A4)-remmers (zoals ritonavir, indinavir, nelfinavir, saquinavir, atazanavir, ketoconazol, itraconazol, voriconazol, fluconazol, cyclosporine, mibefradil, nefazodon, claritromycine, telitromycine, troleandromycin, norfloxacine, ciprofloxacine) of inductoren (bijv. fenobarbital, fenytoïne, barbituraten, carbamazepine, oxcarbazepine, rifabutine, rifampicine, sint-janskruid)

E.5 End points

E.5.1

Primary end point(s)

The parameters that will be obtained with Computational fluid dynamics
(CFD) and used as primary outcome parameters are:
- Total airway volume and total airway resistance
- The number of deposited particles per pre-defined airway section

De parameters die worden verkregen met computationele
stromingsdynamica (CFD) en gebruikt als primaire uitkomstmaten zijn:
- Totaal volume van de luchtwegen en totale weerstand van de
luchtwegen
- Het aantal afgezette deeltjes per vooraf gedefinieerde luchtwegen
sectie

E.5.1.1

Timepoint(s) of evaluation of this end point

December 2014

E.5.2

Secondary end point(s)

Secondary outcome variables that will be obtained with respective tests
are listed below:
Spirometry/ Lung function :
- Forced Expiratory volume in 1 sec (FEV1),
- Forced Vital Capacity (FVC),
- Peak Expiratory Flow (PEF),
- Maximum Expiratory Flow at 25% of FVC (MEF50),
- Maximum Expiratory Flow at 50% of FVC (MEF25),
- Inspiratory Vital Capacity (IVC),
- Tiffeneau Index (FEV1/FVC ratio)
Bodyplethysmography
- Functional Residual Capacity (FRC),
- Total Lung Capacity (TLC),
- Airway resistance: Airway Resistance (Raw), Specific airway
conductance (SGaw)
6 Minute Walk Test
- Exercise capacity: distance walked in 6 minutes (m)
Borg CR10 Scale: measure of the present dyspnea
Visual Analog Scale: measure of the difference in dyspnea before and
after treatment

Secundaire uitkomstvariabelen die zullen worden verkregen met
respectievelijke testen worden hieronder vermeld:
Spirometrie / Longfunctie:
- Geforceerd expiratoire volume in 1 seconde (FEV1),
- Geforceerde vitale capaciteit (FVC),
- Expiratoire piekstroom (PEF),
- Maximale expiratoire flow bij 25% van de FVC (MEF50),
- Maximale expiratoire flow bij 50% van de FVC (MEF25),
- Inspiratoire vitale capaciteit (IVC),
- Tiffeneau Index (FEV1/FVC ratio)
Bodyplethysmography
- Functionele Residuele Capaciteit (FRC),
- Totale longcapaciteit (TLC)
- Weerstand van de luchtwegen: luchtweg weerstand(Raw),Specifieke
luchtwegen geleiding (sGaw)
6 minuten wandeltest
- inspanningscapaciteit: afgelegde afstand in 6 minuten (m)
Borg CR10 Schaal: maat voor de aanwezigheid van dyspnoe
Visuele Analoge Schaal: maat voor het verschil in dyspneu voor en na
behandeling

E.5.2.1

Timepoint(s) of evaluation of this end point

December 2014

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.6

Cross over

Yes

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

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

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

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

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:

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.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 treatment of asthmatic patients

Normale behandeling van astma patiënten

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-08-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-08-11

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

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