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    Summary
    EudraCT Number:2017-004369-29
    Sponsor's Protocol Code Number:206854
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-19
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-004369-29
    A.3Full title of the trial
    The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in a Single Inhaler (TRELEGYTM ELLIPTATM) when Compared with Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients within a Usual Care Setting.

    Short Title: INTREPID: INvestigation of TRELEGY Effectiveness: Usual PractIce
    Design
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Single Inhaler Triple Therapy (fluticasone furoate + vilanterol trifenatate + umeclidinium bromide) (inhaled) - COPD
    A.4.1Sponsor's protocol code number206854
    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 & Development Limited
    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 supportGSK
    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 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0208 990 4466
    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 Yes
    D.2.1.1.1Trade name Trelegy Ellipta
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Trading Services Ltd.
    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.3.1Product nameFluticasone Furoate/Umeclidinium/Vilanterol
    D.3.2Product code GW685698/GSK573719/GW642444
    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 codeGW685698
    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 CodeSUB31865
    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 CodeSUB30696
    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.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
    Chronic Obstructive Pulmonary Disease (COPD) which may be called emphysema or chronic bronchitis.
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease (COPD) COPD is a condition that affects the lungs.
    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 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
    To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA
    MITT for the impact of COPD on wellbeing and daily life after 24 weeks’ treatment.
    E.2.2Secondary objectives of the trial
    Secondary:
    - To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT on lung function after 24 weeks’ treatment.
    - To compare critical errors (CE) made by study participants using the ELLIPTA device with participants using selected non- ELLIPTA MITT after 24 weeks’ treatment.
    Other:
    - To compare TRELEGY ELLIPTA with inhaled non-ELLIPTA MITT for a clinically important deterioration (CID)
    -To quantify the incidence, rate and time to first moderate/severe COPD exacerbation for study participants on TRELEGY ELLIPTA compared with participants on non-ELLIPTA MITT.
    -To compare the effectiveness of TRELEGY ELLIPTA with non-ELLIPTA MITT for COPD-related Healthcare Resource Utilisation (HCRU).
    Exploratory:
    -To assess the data for correlation between critical errors and clinical outcomes
    -To describe the patient study experience
    Safety:
    -To compare safety for study participants using the ELLIPTA device with participants using non-ELLIPTA MITT after 24 weeks’ treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    1. Informed Consent: Capable of giving signed informed consent as described in Appendix 2 of study protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    2. COPD Diagnosis: Patients with a documented physician diagnosis of COPD.
    3. Severity of COPD symptoms: A score of ≥10 on the COPD Assessment Test (CAT) at screening.
    4. History of Exacerbations. Patients who have a history of treatment with systemic/oral corticosteroids, antibiotics and/or hospitalisation for at least one COPD exacerbation in the 3 years prior to randomisation. This will be captured through patient recall and/or medical records and must be documented in patients notes.
    Prior use of systemic/oral corticosteroids and/or antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD.
    5. Existing COPD Maintenance Treatment. Patients currently receiving one of the non-ELLIPTA maintenance therapies listed below who have been prescribed it continually for at least 16 weeks prior to randomisation.
    Continuous prescription is defined as a minimum of 60 days’ prescription cover during the prior 16 weeks.
    The non -ELLIPTA maintenance therapy must be one of the following
    - ICS in combination with LAMA and LABA (MITT)
    - LAMA and LABA used in combination as a dual therapy
    - LABA and ICS used in combination as a dual therapy
    NOTE: patients who are currently on a dual maintenance therapy for COPD must be considered by their physician to require a step- up to triple therapy. The reason for the physician decision to step- up must be documented.
    Patients who are receiving only COPD medication on an ‘as required’ basis are not eligible.
    6. Age and Sex: participants must be aged ≥ 40 years of age at the time of signing the informed consent.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    1. Women of child bearing potential. as defined in Appendix 4 of study protocol. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study.
    2. Medical Conditions: Patients with any life-threatening condition i.e. low probability, in the opinion of the investigator, of 6-month survival due to severity of COPD or comorbid condition.
    3. Patients with unstable COPD. Patients with resolution of an exacerbation less than 2 weeks prior to visit 1, must not be randomised. Patients may be rescreened 2 weeks after resolution of exacerbation (exacerbation is defined by treatment with systemic
    corticosteroids and/or antibiotic).
    4. Other diseases/abnormalities: patients with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which would affect the effectiveness or safety analysis if the
    disease/condition exacerbated during the study
    5. Hypersensitivity: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, β2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator
    contraindicates study participation.
    6. Prior/Concomitant Therapy with Oral Corticosteroid Patients who, in the opinion of the treating investigator, are chronic users of oral
    corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening).
    Chronic use is defined as more than 14 days continuous use during the 12 weeks prior to visit 1.
    7. Participants currently participating in any interventional clinical study.
    Participants taking any investigational drug treatment within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study (whichever is the longer of the two).
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of responders based on the COPD Assessment Test (CAT) at week 24. Response defined as change from baseline of CAT score ≥ 2 at 24 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    1. Change from baseline in Forced Expiratory Volume in one second (FEV1) at 24 weeks (subgroup of patients).

    2. Percentage of participants making at least 1 critical error in inhalation technique at the 24-week visit. (subgroup of patients).
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    The primary purpose of this study is to meet this need by assessing the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA MITT within the usual clinical practice setting
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Effectiveness
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA147
    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
    Germany
    Netherlands
    Spain
    Sweden
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months2
    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 months2
    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: 900
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 3000
    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)
    There is no plan to continue to provide study treatment following the end of the study. At the end of the study, the choice of COPD maintenance treatment is at the discretion and clinical judgment of the physician.
    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 Decision2018-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-10
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