Clinical Trials Register

Summary
EudraCT Number:	2017-003330-91
Sponsor's Protocol Code Number:	BUSAL-II-17-1
National Competent Authority:	Bulgarian Drug Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-10-02
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

Bulgarian Drug Agency

A.2

EudraCT number

2017-003330-91

A.3

Full title of the trial

A pharmacokinetic and pharmacodynamic, randomised, single dose, cross-over, partially blinded study to compare the systemic exposure and the efficacy of a fixed-dose combination of Budesonide-Salmeterol DPI capsule 75-25 μg, Budesonide-Salmeterol DPI capsule 75-12.5 μg, Budesonide-Salmeterol DPI capsule 75-6.25 μg delivered by the Axahaler® versus Serevent® Diskus® 50 μg + Pulmicort® Turbohaler® 100µg co-administration in asthmatic children

A.3.1

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

A study to compare the blood concentration of budesonide and the bronchodilatory effect after administration of the following study drugs: Budesonide-Salmeterol DPI capsule 75-25 μg, Budesonide-Salmeterol DPI capsule 75-12.5 μg, Budesonide-Salmeterol DPI capsule 75-6.25 μg delivered by the Axahaler® versus Serevent® Diskus® 50 μg + Pulmicort® Turbohaler® 100µg co-administration in asthmatic children

A.4.1

Sponsor's protocol code number

BUSAL-II-17-1

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	Laboratoires SMB S.A.
B.1.3.4	Country	Belgium
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	Laboratoires SMB S.A.
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Laboratoires SMB S.A.
B.5.2	Functional name of contact point	Clinical trial information
B.5.3	Address:
B.5.3.1	Street Address	Rue de la Pastorale 26-28
B.5.3.2	Town/ city	Brussels
B.5.3.3	Post code	1080
B.5.3.4	Country	Belgium
B.5.4	Telephone number	32(0)2411 48 28
B.5.5	Fax number	32(0)2411 28 28
B.5.6	E-mail	DptClinique@smb.be

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	Serevent ® Diskus®50µg
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	salmeterol xinafoate
D.3.9.1	CAS number	94749-08-3
D.3.9.3	Other descriptive name	SALMETEROL XINAFOATE
D.3.9.4	EV Substance Code	SUB04314MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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	Yes
D.2.1.1.1	Trade name	Pulmicort® Turbohaler ®100µg
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	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	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: 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	Budesonide/Salmeterol
D.3.2	Product code	Budesonide/Salmeterol
D.3.4	Pharmaceutical form	Inhalation powder, hard capsule
D.3.4.1	Specific paediatric formulation	Yes
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.3.9.2	Current sponsor code	Budesonide
D.3.9.3	Other descriptive name	Budesonide
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	75
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	salmeterol xinafoate
D.3.9.1	CAS number	94749-08-3
D.3.9.2	Current sponsor code	Salmeterol
D.3.9.3	Other descriptive name	Salmeterol
D.3.9.4	EV Substance Code	SUB04314MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	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.IMP: 4
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/Salmeterol
D.3.2	Product code	Budesonide/Salmeterol
D.3.4	Pharmaceutical form	Inhalation powder, hard capsule
D.3.4.1	Specific paediatric formulation	Yes
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.3.9.2	Current sponsor code	Budesonide
D.3.9.3	Other descriptive name	Budesonide
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	75
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	salmeterol xinafoate
D.3.9.1	CAS number	94749-08-3
D.3.9.2	Current sponsor code	Salmeterol
D.3.9.3	Other descriptive name	Salmeterol
D.3.9.4	EV Substance Code	SUB04314MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	12.5
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: 5
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/Salmeterol
D.3.2	Product code	Budesonide/Salmeterol
D.3.4	Pharmaceutical form	Inhalation powder, hard capsule
D.3.4.1	Specific paediatric formulation	Yes
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.3.9.2	Current sponsor code	Budesonide
D.3.9.3	Other descriptive name	Budesonide
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	75
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	salmeterol xinafoate
D.3.9.1	CAS number	94749-08-3
D.3.9.2	Current sponsor code	salmeterol
D.3.9.3	Other descriptive name	salmeterol
D.3.9.4	EV Substance Code	SUB04314MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6.25
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Regular Treatment of Asthma

E.1.1.1

Medical condition in easily understood language

Treatment of Asthma

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10003560
E.1.2	Term	Asthma NOS
E.1.2	System Organ Class	100000015470

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 non-inferiority between budesonide-salmeterol DPI capsule 75/25µg and Serevent® Diskus® 50 μg + Pulmicort® Turbohaler® 100µg co-administration by measurement of the bronchodilating effect
To assess and compare the systemic exposure of budesonide after administration of the two study products (budesonide-salmeterol DPI capsule 75/25µg versus Serevent® Diskus® 50 μg + Pulmicort® Turbohaler® 100µg co-administration) in asthmatic children aged from 6 to 11 years old, inclusive.

E.2.2

Secondary objectives of the trial

To assess the dose-response of Budesonide-Salmeterol by measuring the bronchodilating effect.
To assess and to compare the safety profile of Budesonide-Salmeterol Axahaler® with the Serevent® and the Pulmicort® products.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.1. Male or premenarchal female subjects aged between 6 and 11 years, inclusive.
2. Caucasian.
3. Asthma diagnosed according to the GINA guidelines based on symptoms typical of childhood asthma, within at least 3 months prior to screening.
4. Subject presenting an increase in FEV1 of at least 12% of the FEV1 predicted value at reversibility test after 200µg of salbutamol at screening visit. If the level of reversibility is not achieved at screening, 1 repeat measurement of reversibility is allowed during the screening period within seven days after Visit 1 if there is reasonable belief that the patient can achieve the expected reversibility.
5. Patients not weighing less than 19 kg
6. Body mass index (BMI) within the 5th to 95th percentile of the BMI charts/tables recommended by the world health organization (WHO) based on stature-for-age and weight-for-age and by gender. (Charts presented in appendix 18.6)
7. Present a peak inspiratory flow ≥60L/min with the Axahaler®
8. Able to comply with all study procedures, including the use of study inhalers (AXAHALER®, DISKUS®, TURBOHALER®) and spirometer. Note: Since formal training and test for the correct handling of the DISKUS® and TURBOHALER® inhalers could not be provided the Investigator should check if the child understands the instructions provided for the inhalers use and is aware of their proper use. Willing to withhold the use of short acting β-agonists for at least 6 hours prior to the screening visit and at least 6 hours prior to each study visit.
9. Written informed consent for the patient to participate in the study by the parent(s) or legal guardian(s) as applicable and if possible - a written assent by the patient.

E.4

Principal exclusion criteria

1. Drug addiction or excessive use of xanthine containing beverages (5 cups of tea, coffee, cacao, cola, ice tea)
2. Severe, life-threatening asthma or hospitalisation for an asthma exacerbation within 3 months prior to the screening visit and hospitalisation for a related disorder (pneumothorax, bronchopneumonia etc) in the past 3 months
3. Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormality, or disease
4. Respiratory tract infection requiring treatment with antibiotics within 4 weeks prior to the screening visit
5. Any significant upper and lower respiratory infection (other than asthma) within the previous 4 weeks before screening visit
6. Pure seasonal asthma and/ or a history of seasonal exacerbation of asthma
7. Use of any of the prohibited medications as detailed in the concomitant medication section 10.9
8. Clinical evidence of candidiasis or other fungal airway infection at the screening visit
9. Participation in any other clinical trial within 3 months of the screening visit
10. Blood donation within 3 months before the screening visit
11. Presence of any other condition or illness, which, in the opinion of the investigator would interfere with optimal participation in the study
12 Patients with any sensitivity or allergy to any of the products (including excipients) used within this clinical trial
13 Patient known to have, or at risk of contracting, human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C or patients with positive virology laboratory tests (HBsAg, HCV Ab, HIV 1+2 Ab)
14 Patients with diabetes mellitus
15 Subjects previously enrolled into the current study.
16 First-degree relative of a study investigator, or of employee of the clinical study site or of the sponsor

E.5 End points

E.5.1

Primary end point(s)

- Baseline-adjusted area under the curve (AUC) for FEV1 over 12 hours post dosing
- the following pharmacokinetic parameter will be considered as primary endpoint for budesonide : AUC0-t/Cmax

E.5.1.1

Timepoint(s) of evaluation of this end point

- Period I, Period II, Period III, Period IV

E.5.2

Secondary end point(s)

- The following parameters will be considered as secondary endpoints:
-AUC∞, AUC0-30min, AUC0-2h, tmax and t1/2 for budesonide.

- Safety criteria includes:
- Adverse event profiles
- Vital signs (heart rate, SBP, DBP)
- Tremor
- Serum glucose and potassium measurements
- 12-lead ECG measurements
- Physical examination

+ spirometry parameters:

- Peak bronchodilatory effect (FEV1 max)
- Tmax of FEV1
- FEV1 at 12 hours post dose
- PEF max
- Baseline adjusted area under the curve (AUC) of PEF from 0 to 12 hours post dosing
- PEF at 12 hours post dose
- FEV1 % max
- Baseline adjusted area under the curve (AUC) of FEV1% from 0 to 12 hours post dosing
- FEV1% at 12 hours post dose
- FVC max
- Baseline adjusted area under the curve (AUC) of FVC from 0 to 12 hours post dosing
- FVC at 12 hours post dose
- Partial baseline adjusted area under the curve for FEV1 from 0 to 4 hours post dose
- Partial baseline adjusted area under the curve for FEV1 from 4 to 8 hours post dose
- Partial baseline adjusted area under the curve for FEV1 from 8 to 12 hours post dose
- Percentage of responders patients. Responders are defined as those patients who achieved a > 15% increase in PEF over baseline within 4 hours post-dose
- Duration of effect. The effect is defined by an increase of at least 15% of the baseline value.

E.5.2.1

Timepoint(s) of evaluation of this end point

Screening visit, Period I, Period II, Period III, Period IV (End of study visit)

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

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Partially blinded

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.8.5

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

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

F.3.3.1

Women of childbearing potential not using contraception