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    Summary
    EudraCT Number:2014-005047-40
    Sponsor's Protocol Code Number:SIT001-12
    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:2015-03-20
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2014-005047-40
    A.3Full title of the trial
    A Randomized, Double Blind, Single Dose, Crossover Study, in Subjects with Mild to Moderate Asthma, to Compare the Pharmacodynamic (Bronchodilator) Responses of 12.5/250 µg and 50/250 µg Salmeterol / Fluticasone Propionate (SAL/FP) Delivered Via a Novel Dry Powder Inhaler Device PulmoJet® Versus the Seretide Diskus® 50/250
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in Subjects with Asthma to Compare the Bronchodilatoric Effects of Salmeterol (at two different doses) and Fluticasone Propionate when Taken Via a Novel Inhaler Device (PulmoJet®) Compared to the Seretide Diskus® Inhaler
    A.4.1Sponsor's protocol code numberSIT001-12
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi-Aventis AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi-Aventis AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZentiva Inhalationsprodukte GmbH
    B.5.2Functional name of contact pointMichael Klein
    B.5.3 Address:
    B.5.3.1Street AddressStaffelseestraße 4
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81477
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989710502130
    B.5.5Fax number+49897105029000
    B.5.6E-mailmichael.klein@zentiva.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePulmoJet 12.5/250 SAL/FP
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSALMETEROL XINAFOATE
    D.3.9.1CAS number 94749-08-3
    D.3.9.3Other descriptive nameSALMETEROL XINAFOATE
    D.3.9.4EV Substance CodeSUB04314MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUTICASONE PROPIONATE
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePulmoJet 50/250 SAL/FP
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSALMETEROL XINAFOATE
    D.3.9.1CAS number 94749-08-3
    D.3.9.3Other descriptive nameSALMETEROL XINAFOATE
    D.3.9.4EV Substance CodeSUB04314MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUTICASONE PROPIONATE
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Seretide Diskus
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome Ltd. UK, trading as Allen&Hanburys
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSeretide Diskus
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSALMETEROL XINAFOATE
    D.3.9.1CAS number 94749-08-3
    D.3.9.3Other descriptive nameSALMETEROL XINAFOATE
    D.3.9.4EV Substance CodeSUB04314MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUTICASONE PROPIONATE
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild to moderate asthma
    E.1.1.1Medical condition in easily understood language
    Mild to moderate asthma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10003565
    E.1.2Term Asthmatic
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate the therapeutic non-inferiority of the bronchodilator responses (area under the time curve of forced expiratory volume in 1 second [AUC-FEV1]) over 12 hours of the salmeterol component (50 µg) of a novel SAL/FP combination dry powder inhaler product (PulmoJet 50 µg/250 µg SAL/FP; test) with the respective mid-strength of the European reference product (Seretide Diskus; reference).
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    • To compare the bronchodilator dose responses AUC-FEV1 over 12 hours between the salmeterol components of 2 doses (12.5 µg and 50 µg) of a novel SAL/FP combination dry powder inhaler product (PulmoJet; test) and with the respective mid-strength of the European reference product (Seretide Diskus; reference) in order to assess assay sensitivity.
    • To assess and compare the duration and maximum bronchodilator responses in forced expiratory volume in 1 second (FEV1) between the salmeterol component of 2 doses (12.5 µg and 50 µg) of a novel SAL/FP combination dry powder inhaler product (PulmoJet; test) and with the respective mid-strength of the European reference product (Seretide Diskus; reference).
    • To assess the local and systemic tolerability and safety of the investigational treatments.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Body weight of ≥50 kg for adults, ≥ 30 kg for adolescents, and body mass index between ≥18 and ≤30 kg/m2.
    2.Baseline FEV1 of 50% to 85% of predicted normal for adults (age, sex, and height), and 60% to 90% of predicted normal for adolescents (after abstinence from SABA treatment larger than 6 hours).
    3.Subjects must demonstrate bronchodilator reversibility of at least 15% and at least 250 mL increase in FEV1 15 to 30 minutes after 400 µg salbutamol at screening. If the level of reversibility is not achieved at screening, 1 repeat measurement of reversibility is allowed during the run-in period at least 24 hours prior to Visit 2.
    4.Subjects must demonstrate FEV1 stability prior to any treatment period: FEV1 at pre dose randomization (baseline 1st treatment period) must be within ± 10% of the screening value. FEV1 between individual baselines before each treatment period must be within ±10% of baseline of 1st treatment period. All baseline FEV1 values will be determined by the mean of 2 pre-dose spirometries.
    5.Female subjects must be either at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception. Women of childbearing potential must have a negative pregnancy test at Screening Visit (Visit 1) and be using at least 2 months before the screening visit, at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal intrauterine devices, sexual abstinence or vasectomy of the partner. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the study, and withdrawal are not acceptable methods of contraception.
    6.Having provided written informed consent after the subject has been informed both verbally and in writing about the scope and objectives of the study, the methods employed, and the anticipated benefits and potential risks and discomfort to which he / she may be exposed. For adolescent subjects, the informed consent by the subject’s parent / legal guardian assent (if possible also by the subject) must be given in written form after being provided with detailed information about the nature, risks and scope of the clinical trial as well as the expected desirable and adverse effects of the drug.
    E.4Principal exclusion criteria
    1.History of clinically relevant allergies or idiosyncrasies to fluticasone propionate, salmeterol, lactose, or any other inactive ingredient(s) of the investigational products.
    2.History of any other significant drug hypersensitivity or other significant allergic diathesis. Subjects with uncomplicated seasonal allergic rhinitis can be accepted if expected allergy season is clearly outside enrolment / treatment period. Active allergic rhinitis is excluded.
    3.History of life-threatening asthma or severe asthma exacerbation requiring hospitalization within the last 12 months before screening.
    4.Asthma exacerbation requiring a treatment course of systemic (i.e., oral or parenteral) corticosteroids within the 3 months before screening or ≥ 3 courses within the last 12 months before screening.
    5.Lactating or pregnant female, or female of child-bearing potential not employing highly effective contraception (methods with a Pearl Index lower than 1% are regarded as highly-effective), or female planning to become pregnant during study participation. A male subject planning to father a child during study participation.
    6.Clinical significant diseases, conditions, or illnesses at screening, that might interfere with the study methodologies, objectives, or safety of the subject.
    7.Acute or chronic viral, bacterial or fungal airway infections, including laryngeal infections, mouth and throat infections, and hoarseness 4 weeks prior to screening and during run-in.
    8.Other clinically relevant chronic or acute infectious illnesses or febrile infections within 4 weeks prior to start of the study and during run-in.
    9.Current uncontrolled arterial hyper- or hypotension as evidenced by measured blood pressure values at screening.
    10.Electrocardiogram abnormalities of clinical relevance, in particular abnormal prolongations of QT / QTc- or PR-interval (i.e., QTc Fridericia ≥ 450 ms, PR ≥ 220 ms) or heart rate of ≤ 45 or ≥ 90 beats/minute (at rest).
    11.Clinical chemical, hematological or any other laboratory parameters clinically relevant outside the normal range considering in particular: hypokalemia, hypoglycemia, hyperglycemia or pathological glucose tolerance (minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance).
    12.Positive results in any of the virology tests for human immunodeficiency virus (HIV)-antibody (Ab), hepatitis C virus antibodies (HCV-Ab) and hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab) (if positive to be verified by test for HBc-IgM).
    13.Use of medications containing β-adrenoceptor agonists or β-adrenoceptor blockers within the past 7 days before Screening Visit 1 and throughout study participation.
    14.Use of medium- or long-acting anti-cholinergic / -muscarinic bronchodilators such as ipratropium, tiotropium, and inhaled LABAs within the 48 hours before Screening Visit 1 and throughout study participation.
    15.Use of oral/parenteral corticosteroids within the past 3 months before screening, Visit 1.
    16.Ongoing immunotherapy (e.g., omalizumab) during the last 3 months or planned start of immunotherapy within the study period.
    17. The use of other prior and concomitant medications as specified in the protocol.
    18.Subject shows evidence for current alcohol abuse or history of illicit drug abuse.
    19.Subject receives concomitant medications not (yet) stabilized on a maintenance dose (i.e., treatments undergoing current up-titration or down-tapering steps).
    20.Subject was previously enrolled into the current study.
    21.Subject is the Investigator in the current study, or a first-degree relative of a study Investigator, or is employee of a clinical study site or the Sponsor.
    22.Subject participated in a previous clinical study with another investigational product within the last 30 days (or 6 half-lives, whichever is longer) prior to the start of the study or subject participates in a concurrent study.
    23.Subject has donated blood within the last 30 days prior to the start of the study.
    24.Subject is considered unable or unwilling to co-operate adequately, i.e., to follow study procedures and investigator instructions adequately (e.g., language difficulties).
    25.Subject is a "vulnerable" individual (e.g., person is kept in detention).
    26.Subject is anticipated to be not available for scheduled study visits / procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Baseline adjusted AUC-FEV1 calculated from time zero to 12 hours (AUC0-12h): 0 hours pre-dose (approximately taken at 0.75 and 0.25 pre-dose) and 0,5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose) after single dose treatment of 1 inhalation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    FEV1 at 0 hours pre-dose (the mean of 2 separate spirometries performed for logistical reasons about 45 and 15 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose.
    E.5.2Secondary end point(s)
    •The maximum baseline-adjusted FEV1 will be compared between the treatments using a t-test.

    •Duration of effective bronchodilatation (i.e., duration of increase in FEV1 ≥ 15% from baseline over a 12-hour observation period) after single-dose treatment of 1 inhalation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    FEV1 at 0 hours pre-dose (the mean of 2 separate spirometries performed for logistical reasons about 45 and 15 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacodynamic study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 12
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 108
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects will proceed with their previous treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-25
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