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    Summary
    EudraCT Number:2011-002451-33
    Sponsor's Protocol Code Number:HZC115805
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-31
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2011-002451-33
    A.3Full title of the trial
    A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate /Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once-Daily via a Novel Dry Powder Inhaler Compared with Tiotropium Bromide Inhalation Powder 18mcg Delivered Once-Daily via the HandiHaler® in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Who Have or Are at Risk for Co-morbid Cardiovascular Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-week study to test lung function in people with COPD and who have or at risk for cardiovascular disease
    A.4.1Sponsor's protocol code numberHZC115805
    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 Ltd
    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 Research and Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research and 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+4402089904466
    B.5.5Fax number+4402089904466
    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/GW642444 Inhalation Powder
    D.3.2Product code Fluticasone Furoate/GW642444 Inhalation Powder
    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 INNFluticasone Furoate
    D.3.9.1CAS number 397864-44-7
    D.3.9.2Current sponsor codeGW685698X
    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 INNVilanterol trifenatate
    D.3.9.1CAS number 503070-58-4
    D.3.9.2Current sponsor codeGW642444M
    D.3.9.3Other descriptive nameVilanterol trifenatate
    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 SPIRIVA®
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International
    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 nameTiotropium
    D.3.2Product code Tiotropium
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 411207313
    D.3.9.3Other descriptive nameTiotropium bromide monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 Yes
    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, hard capsule
    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, pre-dispensed
    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 (COPD)
    E.1.1.1Medical condition in easily understood language
    Chronic bronchitis
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    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 of this study is to evaluate the efficacy (particularly the change from baseline trough in 24-hour weighted-mean serial FEV1 at the end of a 12-week treatment period) and safety of FF/VI Inhalation Powder 100/25mcg once-daily (QD) via the NDPI compared with tiotropium bromide inhalation powder 18mcg delivered QD via the HandiHaler over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease.
    E.2.2Secondary objectives of the trial
    Characterize the time to onset (increase of 100mL above baseline in FEV1) on Treatment Day 1 (Visit 2) of both FF/VI Inhalation Powder 100/25 mcg QD and tiotropium bromide inhalation powder 18mcg QD.

    Evaluate the change from baseline in clinic visit trough FEV1 at Treatment Day 84 (Visit 5) of both FF/VI Inhalation Powder 100/25 mcg QD and tiotropium bromide inhalation powder 18mcg QD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the IB/IB Supplements and Prescribing Information (tiotropium bromide).

    Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.

    Subjects eligible for enrolment in the study must meet all of the following criteria:

    1.Type of subject: Outpatient
    2.Informed consent: Subjects must give their signed and dated written informed consent to participate.
    3.Gender: Male or female subjects
    Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
    4.Age: equal or more than 40 years of age at Screening (Visit 1)
    5.COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]:
    COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
    6.Severity of Disease:
    •Subject with a measured post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 at Screening (Visit 1) [Pelligrino, 2005]
    •Subjects with a measured post-albuterol/salbutamol FEV1 ≥30 to ≤70% of predicted normal values calculated (via centralized vendor equipment) using NHANES III reference equations [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1).
    Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The study-provided central spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values.
    7.Tobacco use: Subjects with a current or prior history of more than10 pack-years of cigarette smoking at Screening (Visit 1). Former 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.
    Number of pack years = (number of cigarettes per day/20) x number of years smoked
    8.Cardiovascular Disease/Risk Factors:
    Subjects must have either
    •A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following:
    •Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD)
    •Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD)
    •Previous stroke
    •Objectively confirmed TIA (i.e., transient neurological deficit documented by a health-care professional)
    •Previous Myocardial Infarction (MI) (Note: An MI within 6 months prior to Visit 1 is exclusionary)
    OR
    •Presence of one of the following cardiovascular risk factors (in addition to being a former/current smoker):

    •Current diagnosis of hypertension
    •Current diagnosis of hypercholesterolemia
    •Diabetes mellitus treated with pharmacotherapy
    E.4Principal exclusion criteria
    1. 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)
    2. Other respiratory disorders: Subjects with 1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases
    3. Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1)
    4. Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD.
    5. Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12 weeks prior to Screening (Visit 1).
    6. Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of the following in the 6 weeks prior to Screening (Visit 1):
    Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician.
    7. Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Screening (Visit 1).
    8. COPD exacerbation/lower respiratory tract infection during Run-In Period: Subjects who experience a moderate/severe COPD exacerbation (See definitions in Section 6.3.13) and/or a lower respiratory infection (including pneumonia) during the Run-In period.
    9. Abnormal clinically significant laboratory finding: Subjects who have an abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization.
    10. Abnormal and clinically significant 12-lead ECG at Screening (Visit 1): Subjects
    who have an abnormal, clinically significant ECG finding at Screening (Visit 1) or
    upon repeat prior to randomization. Investigators will be provided with ECG
    reviews, conducted by a centralized, independent cardiologist, to assist in evaluation
    of subject eligibility. For this study, an abnormal and clinically significant finding
    that would preclude a subject from entering the trial is defined as a 12-lead tracing
    that is interpreted as, but not limited to, the findings listed in Appendix 1 (See Protocol). The study
    investigator will determine the medical significance of any ECG abnormalities not
    listed in Appendix 1 (See Protocol) and determine if the subject is precluded from entering the
    study (ECG[s] collected prior to randomization).

    For further exclusion criteria, please refer to the Protocol Section 4.3.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline trough in 24-hour weighted-mean serial FEV1 at the end of 12 weeks of treatment on Treatment Day 84 (Visit 5). This weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15 and 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84 (Visit 5).
    Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes pre-dose on Treatment Day 1 (Visit 2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment Day 84 (Visit 5)
    E.5.2Secondary end point(s)
    Time to onset (increase of 100mL above baseline in FEV1) on Treatment Day 1 (Visit 2)

    Change from baseline in Clinic Visit trough (pre-bronchodilator and pre-dose) FEV1 at Treatment Day 84 (Visit 5)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment Day 1 (Visit 2)

    Treatment Day 84 (Visit 5)
    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 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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tiotropium
    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 EEA40
    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
    Canada
    United States
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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: 355
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 245
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 385
    F.4.2.2In the whole clinical trial 600
    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)
    At the end of the treatment (Visit 5 or Early Withdrawal), subjects can resume conventional COPD therapy as prescribed by the Investigator. There are no plans to provide the study drug for compassionate use following 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 Decision2012-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-21
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