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    Summary
    EudraCT Number:2015-000717-40
    Sponsor's Protocol Code Number:CCD-05993AB2-02
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-06
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2015-000717-40
    A.3Full title of the trial
    A 52 week, randomized, double blind, multinational, multicentre, active controlled, 3-arm parallel group trial comparing CHF 5993 200/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) to CHF 1535 200/6 µg pMDI (fixed combination of extrafine beclomethasone dipropionate plus formoterol fumarate) alone or on top of open-label tiotropium 2.5 µg Respimat® in patients with asthma uncontrolled on high doses of inhaled corticosteroids in combination with long-acting ß2-agonists
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to evaluate the effect of a new fixed triple combination of beclometasone dipropionate + formoterol fumarate + glycopyrronium bromide at high dose in patients with uncontrolled asthma.
    A.3.2Name or abbreviated title of the trial where available
    Trigger
    A.4.1Sponsor's protocol code numberCCD-05993AB2-02
    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 SponsorChiesi Farmaceutici S.p.A.
    B.1.3.4CountryItaly
    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 supportChiesi Farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiesi Farmaceutici S.p.A.
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressVia Palermo 26/A
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43122
    B.5.3.4CountryItaly
    B.5.4Telephone number+33147684812
    B.5.5Fax number+33147684904
    B.5.6E-mailclinicaltrials_info@chiesi.com
    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 nameCHF 5993 pMDI
    D.3.2Product code CHF 5993
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    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 INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.3Other descriptive nameBDP
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFORMOTEROL FUMARATE
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFF
    D.3.9.4EV Substance CodeSUB02257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.3Other descriptive nameGB
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.11 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 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 Fostair
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici S.p.A.
    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 nameFostair
    D.3.2Product code CHF 1535
    D.3.4Pharmaceutical form Pressurised inhalation, solution
    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 INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.3Other descriptive nameBDP
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFORMOTEROL FUMARATE
    D.3.9.1CAS number 43229-80-7
    D.3.9.3Other descriptive nameFF
    D.3.9.4EV Substance CodeSUB02257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Spiriva Respimat
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Inhalation solution
    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 INNTIOTROPIUM BROMIDE
    D.3.9.1CAS number 136310-93-5
    D.3.9.4EV Substance CodeSUB11095MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Uncontrolled asthma
    E.1.1.1Medical condition in easily understood language
    Uncontrolled 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To demonstrate the superiority of CHF 5993 200/6/12.5 pMDI compared to CHF 1535 200/6 pMDI in terms of change from baseline in pre-dose FEV1 at Week 26.
    - To demonstrate the reduction of moderate and severe asthma exacerbations rate with CHF 5993 200/6/12.5 pMDI compared to CHF 1535 200/6 pMDI during the entire 52-week treatment period.
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives:
    - To demonstrate the superiority of CHF 5993 200/6/12.5 pMDI compared to CHF 1535 200/6 pMDI in terms of change from baseline in peak FEV1 within 3 hours post-dose at Week 26.
    - To demonstrate the superiority of CHF 5993 200/6/12.5 compared to CHF 1535 200/6 in terms of change from baseline in morning PEF averaged over 26-week treatment period.
    - To demonstrate the reduction of severe asthma exacerbations rate with CHF 5993 200/6/12.5 pMDI compared to CHF 1535 200/6 pMDI during the entire 52-week treatment period in the pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials.

    Safety Objective:
    - To assess the safety and tolerability of the study treatments
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient’s written informed consent obtained prior to any study-related procedures.
    2. Male or female patients aged greater than or equal to 18 and ≤75 years.
    3. Patients must have a documented history of asthma for at least 1 year and asthma must have been diagnosed before the patient’s age of 40.
    4. Patients with uncontrolled asthma with double therapy only on high doses of ICS (>1000 daily dose BDP non-extrafine or estimated clinical comparable dose) in combination with a β2 long-acting bronchodilator (LABA) at a stable dose for at least 4 weeks prior to screening. LABA daily dose: patients under formoterol 24 μg or salmeterol 100 μg or vilanterol 25 µg or other approved dose of LABA as vlinivally comparable to the others in the list can be included.
    5. Patients with a pre-bronchodilator FEV1 <80% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization visits.
    6. Patients with a positive response to a reversibility test at screening, defined as ΔFEV1>12% and >200mL over baseline 10-15 minutes after inhaling 400 μg of salbutamol pMDI.
    7. Patients with uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire 7 © (ACQ-7) ≥1.5 (this criterion must be met at screening and at the end of the run-in period).
    8. A documented history of one or more asthma exacerbations requiring treatment with systemic corticosteroids or emergency department visit or in-patient hospitalization in the previous 12 months.
    9. A co-operative attitude and ability:
    - to be trained to correctly use the pMDI inhalers;
    - to perform all trial related procedures including technically acceptable pulmonary function tests;
    - to correctly use the electronic diary/peak flow meter.
    E.4Principal exclusion criteria
    1. Inability to carry out pulmonary lung function testing, to comply with study procedures or with study treatment intake.
    2. Run-in compliance < 50% at randomisation.
    3. History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit which, in the judgement of the investigator, may place the patient at undue risk.
    4. Hospitalisation, emergency room admission or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to screening visit or during the run-in period.
    5. Patients with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to the screening visit or during run-in period.
    6. Any change in dose, schedule or formulation of the combination ICS plus LABA in the 4 weeks prior to screening visit.
    7. Patients using systemic corticosteroid medication in the 4 weeks prior to screening or slow release corticosteroids in the 12 weeks before screening.
    8. Patients who suffer from COPD as defined by the current GOLD guidelines.
    9. History of a diagnosis of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations.
    10. Current smokers or ex-smokers with total cumulative exposure equal or more than 10 pack-years or having stopped smoking one year or less prior to screening visit.
    11. Patients who have clinically significant cardiovascular condition according to investigator’s judgement
    12. An abnormal and clinically significant 12-lead ECG that results in active medical problem which may impact the safety of the patient according to investigator’s judgement.
    13. Patients whose electrocardiogram (12-lead ECG) shows QTcF >450 ms for males or QTcF >470 ms for females at screening or at randomisation visits (criterion not applicable for patient with pacemaker or permanent atrial fibrillation).
    14. Patients with a medical history or current diagnosis of narrow-angle glaucoma, symptomatic prostatic hypertrophy, urinary retention bladder neck obstruction that, in the opinion of the investigator, would prevent use of anticholinergic agents.
    15. Other severe acute or chronic medical or malignancy or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    16. Patients having received a vaccination within 2 weeks prior to screening or during the run-in.
    17. Patients mentally or legally incapacitated, or patients accommodated in an establishment as a result of an official or judicial order.
    18. Patients with a history of alcohol or drug abuse within two years prior to the start of the study.
    19. Patients with known intolerance/hypersensitivity or contra-indication to treatment with ß2-agonists, inhaled corticosteroids, anticholinergics or propellant gases/excipients.
    20. Patients with major surgery in the 3 months prior to screening visit or planned surgery during the trial.
    21. Patients treated with non-potassium sparing diuretics (unless administered as a fixed-dose combination with a potassium conserving drug or changed to potassium sparing before the screening), non-selective beta-blocking drugs, quinidine, quinidine-like anti arrhythmics, or any medication with a QTc prolongation potential or a history of QTc prolongation.
    22. Patients treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants.
    23. Patients being treated with monoclonal antibodies (e.g. anti-IgE or anti-IgG antibodies) or biological drugs.
    24. Patients who are receiving any therapy that could interfere with the study drugs according to investigator’s opinion.
    25. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) unless are willing to use one or more highly effective contraceptive measures.
    26. Patients who have received an investigational drug within 2 months or six half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in pre-dose FEV1 at Week 26
    - Moderate and severe exacerbations rate over 52 weeks of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    26 weeks and 52 weeks
    E.5.2Secondary end point(s)
    - Change from baseline in peak FEV1 (within 3 hours post dosing) at Week 26.
    - Change from baseline in morning PEF measured by patients at home over the 26-week treatment period.
    - Severe exacerbations rate over 52 weeks of treatment in a pre-specified pooled analysis of the two pivotal studies CCD-5993AB1-03 and CCD-05993AB2-02
    - Safety variables, AEs, ADRs
    E.5.2.1Timepoint(s) of evaluation of this end point
    26 weeks and 52 weeks
    Safety throughout the study
    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 No
    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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Treatment arms A and B are double-blind; Treatment arm C is open-label
    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.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA162
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belarus
    Bulgaria
    Czech Republic
    Germany
    Hungary
    Italy
    Lithuania
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    Spain
    Turkey
    Ukraine
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1076
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 359
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 879
    F.4.2.2In the whole clinical trial 1435
    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)
    Before discharge, the investigator will prescribe the most appropriate treatment or restore the initial therapy or refer to the General Practitioner.
    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 Decision2016-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-28
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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