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    Summary
    EudraCT Number:2013-003073-10
    Sponsor's Protocol Code Number:CTT116853
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-02
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2013-003073-10
    A.3Full title of the trial
    A Phase III, 24 week, randomized, double blind, double dummy, parallel group study (with an extension to 52 weeks in a subset of subjects) comparing the efficacy, safety and tolerability of the fixed dose triple combination FF/UMEC/VI administered once-daily in the morning via a dry powder inhaler with budesonide/formoterol 400mcg/12mcg administered twice-daily via a reservoir inhaler in subjects with chronic obstructive pulmonary disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 24 week study (with an extension to 52 weeks in a proportion of subjects) to compare the safety and effectiveness of FF/UMEC/VI with budesonide/formoterol in subjects with COPD
    A.4.1Sponsor's protocol code numberCTT116853
    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 SponsorGlaxoSmithKline Research and Development
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 - 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0208 990 44 66
    B.5.5Fax number+44 0208 990 12 34
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameFluticasone Furoate/Umeclidinium/Vilanterol
    D.3.2Product code GSK2834425
    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 INNFLUTICASONE FUROATE
    D.3.9.1CAS number 397864-44-7
    D.3.9.2Current sponsor codeGW685698
    D.3.9.3Other descriptive nameFluticasone Furoate
    D.3.9.4EV Substance CodeSUB26593
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUmeclidinium
    D.3.9.1CAS number 869113-09-7
    D.3.9.2Current sponsor codeGSK573719
    D.3.9.3Other descriptive nameGSK573719A
    D.3.9.4EV Substance CodeSUB119778
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVilanterol Trifenatate
    D.3.9.1CAS number 503068-34-6
    D.3.9.2Current sponsor codeGW642444
    D.3.9.3Other descriptive nameGW642444M
    D.3.9.4EV Substance CodeSUB77409
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Symbicort Turbohaler 400 micrograms/12 micrograms/inhalation, inhalation powder
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 nameFORMOTEROL FUMARATE
    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 number12
    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
    Chronic Obstructive Pulmonary Disease
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    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 evaluate the effects of FF/UMEC/VI on lung function and health related quality of life compared with budesonide/formoterol after 24 weeks of treatment
    E.2.2Secondary objectives of the trial
    - To evaluate the effect on annual rate of exacerbations of FF/UMEC/VI compared to budesonide/formoterol

    - To evaluate the safety profile of FF/UMEC/VI compared to budesonide/formoterol over 24 weeks and 52 weeks of treatment
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title:
    Genetic Research

    Objectives:
    The objectives of the genetic research are to investigate the relationship between genetic variants and:

    - Response to medicine, including Fluticasone Furoate (FF)/Umeclidinium (UMEC)/Vilanterol (VI), Budesonide Formoterol or any concomitant medicines;

    - COPD susceptibility, severity, and progression and related conditions
    E.3Principal inclusion criteria
    Subjects eligible for enrolment in the study must meet all of the following criteria:

    1. Informed Consent: A signed and dated written informed consent prior to study participation.

    2. Type of subject: Outpatient.

    3. Age: Subjects 40 years of age or older at Screening (Visit 1).

    4. Gender: Male or female subjects.

    A female is eligible to enter and participate in the study if she is of:

    Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy.

    OR

    Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to safety follow-up contact):

    - Abstinence
    - Oral Contraceptive, either combined or progestogen alone
    - Injectable progestogen
    - Implants of levonorgestrel
    - Estrogenic vaginal ring
    - Percutaneous contraceptive patches
    - Intrauterine device (IUD) or intrauterine system (IUS)
    - Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records.
    - Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent(foam/gel/film/cream/suppository)

    5. COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004].

    6. Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years at Screening (Visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history.

    7. Severity of COPD symptoms: A score of ≥10 on the COPD Assessment Test (CAT) at Screening (Visit 1).

    8. Severity of Disease:

    Subjects must demonstrate at Screening:

    - a post-bronchodilator FEV1 <50% predicted normal

    OR

    - a post-bronchodilator FEV1 <80% predicted normal and a documented history of ≥2 moderate exacerbations or one severe (hospitalized) exacerbation in the previous 12 months Subjects must also have a measured post albuterol/salbutamol FEV1/FVC ratio of <0.70 at screening.

    Note: Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations [Quanjer, 2012].

    Note: A documented history of a COPD exacerbation (e.g., medical record verification) is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalization (for a severe exacerbation).

    Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnoea, sputum volume, or sputum purulence (colour). Subject verbal reports are not acceptable.

    9. Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening.

    Note: Subjects receiving only PRN COPD medications are not eligible.

    10. Liver function tests:

    - alanine aminotransferase (ALT) <2x upper limit of normal (ULN);
    - alkaline phosphatase ≤1.5xULN
    - bilirubin ≤1.5xULN (isolated bilirubin >1.5 x ULN is acceptable if
    bilirubin is fractionated and direct bilirubin <35%).

    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:

    1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.

    2. Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).

    3. α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying cause of COPD.

    4. Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.

    5. Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening.

    6. Risk Factors for Pneumonia: immune suppression (e.g. HIV, Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis).

    Patients at potentially high risk (e.g. very low BMI, severely malnourished, or very low FEV1) will only be included at the discretion of the investigator.

    7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded.

    8. Respiratory tract infection that has not resolved at least 7 days prior to Screening.

    9. Abnormal Chest x-ray: Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening Visit 1) (or historical radiograph or CT scan obtained within 3 months prior to screening) that will be over-read by a central vendor.

    Note: Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 3 months of screening must provide a post pneumonia/exacerbation chest x-ray to be over-read by the central vendor or have a chest x-ray conducted at Screening.

    For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (BfS).

    10. Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.

    For subjects taking part in the physical activity monitor subset: Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns and limit the ability to walk/cycle, as judged by the Investigator.

    11. Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria.

    12. Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded:

    - Myocardial infarction or unstable angina in the last 6 months
    - Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months
    - NYHA Class IV Heart failure

    13. Abnormal and clinically significant 12-Lead ECG finding:
    Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The PI will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial.

    For the remaining exclusion criteria please refer to protocol page 33 and 34.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in trough FEV1 at Week 24
    - Change from baseline in SGRQ total score at Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Change from baseline in trough FEV1 at 24 weeks: Visit 2 (Day 1) and Visit 6 (Week 24)
    - Change from baseline in SGRQ total score at 24 weeks: Visit 2 (Day 1) and Visit 6 (Week 24)
    E.5.2Secondary end point(s)
    - Annual rate of on-treatment moderate and/or severe COPD exacerbations

    - Assessment of respiratory symptoms using EXACT Respiratory Symptoms PRO and its subscales (breathlessness, cough and sputum and chest symptoms)

    - Transitional Dyspnea Index (TDI) focal score at Week 24

    - Daily Activity Question
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Annual rate of on-treatment moderate and/or severe COPD exacerbations: Visit 2 (Day 1) to Visit 6 (Week 24) or Visit 8 (Week 52)-for the subset of subjects continuing for an additional 28 weeks or at Early Withdrawal.
    - Assessment of respiratory symptoms using EXACT Respiratory Symptoms PRO and its subscales (breathlessness, cough and sputum and chest symptoms) : Daily from Visit 1 (Week 2) to Visit 6 (Week 24) or Visit 8 (Week 52)- for the subset of subjects continuing for an additional 28 weeks or at Early Withdrawal.
    - Transitional Dyspnea Index (TDI) focal score at 24 weeks: Visit 6 (24 weeks)
    - Daily Activity Question: Daily from Visit 1 (Week 2) to Visit 6 (Week 24) or Visit 8 (Week 52)- for the subset of subjects continuing for an additional 28 weeks or at Early Withdrawal.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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
    Double dummy
    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 trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA136
    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
    Bulgaria
    China
    Czech Republic
    Estonia
    Germany
    Greece
    Hungary
    Italy
    Korea, Republic of
    Mexico
    Philippines
    Poland
    Romania
    Russian Federation
    Slovakia
    Taiwan
    Ukraine
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days3
    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: 1061
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 1061
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1143
    F.4.2.2In the whole clinical trial 2122
    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)
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the patient's medical condition.

    GSK will not provide post-study treatment. There are no plans to provide IP for compassionate use following study completion.
    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 Decision2014-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-07
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