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    Summary
    EudraCT Number:2012-004966-16
    Sponsor's Protocol Code Number:CQVA149A2318
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-25
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-004966-16
    A.3Full title of the trial
    A 52-week treatment, multi-center, randomized, double-blind, double-dummy, parallel-group, active controlled study to compare the effect of QVA149 (indacaterol maleate / glycopyrronium bromide) with salmeterol/fluticasone on the rate of exacerbations in subjects with moderate to very severe COPD.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety of QVA149 compared to salmeterol/fluticasone active comparator in patients with COPD.
    A.4.1Sponsor's protocol code numberCQVA149A2318
    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 SponsorNovartis Pharma Services 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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressStella-Klein-Löw-Weg 17
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1020
    B.5.3.4CountryAustria
    B.5.4Telephone number+43186657 0
    B.5.5Fax number+431866576458
    B.5.6E-maildra.austria@novartis.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 nameindacaterol maleate/glycopyrronium bromide
    D.3.2Product code QVA149
    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 INNindacaterol
    D.3.9.1CAS number 753498-25-8
    D.3.9.2Current sponsor codeQAB149
    D.3.9.3Other descriptive nameINDACATEROL MALEATE
    D.3.9.4EV Substance CodeSUB30300
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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.3.9.2Current sponsor codeNVA237
    D.3.9.3Other descriptive nameglycopyrronium bromide
    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 number50
    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.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 Seretide
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK Ltd
    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 namesalmeterol/fluticasone
    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
    D.3.9.1CAS number 89365-50-4
    D.3.9.4EV Substance CodeSUB10430MIG
    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
    D.3.9.1CAS number 90566-53-3
    D.3.9.4EV Substance CodeSUB07760MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    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
    subjects with moderate to very severe COPD
    E.1.1.1Medical condition in easily understood language
    subjects with moderate to very severe COPD
    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 10010953
    E.1.2Term COPD exacerbation
    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 demonstrate that QVA149 (110/50 μg o.d.) is at least noninferior to salmeterol/fluticasone (50/500 μg b.i.d.) in terms of rate of COPD exacerbations (mild/moderate/severe) during 52 weeks of
    treatment.
    E.2.2Secondary objectives of the trial
    To demonstrate that QVA149 (110/50 μg o.d.) is superior to salmeterol/fluticasone (50/500 μg b.i.d.) in terms of rate of all COPD exacerbations during 52 weeks of treatment.
    To evaluate the effect of QVA149 compared to salmeterol/fluticasone during 52 weeks of treatment in terms of:
    • Time to first COPD exacerbation (mild/moderate/severe).
    • Rate and time to first moderate/severe COPD exacerbations.
    To evaluate the effect of QVA149 compared to salmeterol/fluticasone in terms of:
    • FEV1 (including morning pre-dose FEV1) and FVC on Day 1 and after 4, 12, 26, 38
    and 52 weeks of treatment.
    • Lung function in terms of standardized FEV1 AUC (0 – 12h), in a subset of patients.
    • Total score of the St. George’s Respiratory Questionnaire (SGRQ-C) after 4, 12, 26,
    38 and 52 weeks of treatment
    • Mean use of rescue therapy over the 52 weeks treatment period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained before any assessment is performed.
    2. Male or female adults aged ≥40 years.
    3. Patients with stable COPD according to the current GOLD strategy (GOLD 2011).
    4. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten packyears
    are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
    5. Patients with a post-bronchodilator FEV1 ≥25 and < 60% of the predicted normal value,
    and post-bronchodilator FEV1/FVC < 0.70 at Visit 101 (day -28).
    (Post refers to 1 h after sequential inhalation of 84 μg (or equivalent dose) of ipratropium
    bromide and 400 μg of salbutamol).
    6. A documented history of at least 1 COPD exacerbation in the previous 12 months that
    required treatment with systemic glucocorticosteroids and/or antibiotics.
    7. Patients taking stable COPD medication (at least 60 days) prior to Visit 101.
    8. Patients with an mMRC grade of at least 2 at Visit 101 (day -28).
    E.4Principal exclusion criteria
    1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
    female after conception and until the termination of gestation, confirmed by a positive
    hCG (human Chorionic Gonadotropin) laboratory test.
    2. Women of child-bearing potential, defined as all women physiologically capable of
    becoming pregnant, unless they are using effective methods of contraception during
    dosing of study treatment. Effective contraception methods include:
    • Total abstinence when this is in line with the preferred and usual lifestyle of the
    subject (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
    methods) and withdrawal are not acceptable methods of contraception).
    • Female sterilization defined as surgical hysterectomy, bilateral oophorectomy, or
    tubal ligation at least six weeks before taking the study treatment (Single
    oophorectomy does not meet the definition of female sterilization).
    • Male sterilization (at least 6 months prior to screening). For female subjects on the
    study, the vasectomized male partner should be the sole partner for that subject.
    • Barrier methods of contraception: condom or occlusive cap (diaphragm or
    cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
    • Use of oral, injected or implanted hormonal methods of contraception or other forms
    of hormonal contraception that have comparable efficacy (failure rate <1%), for
    example hormone vaginal ring or transdermal hormone contraception. In case of use
    of oral contraception women should have been stable on the same pill for a minimum
    of 3 months before taking study treatment.
    • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    Women are considered post-menopausal and not of child bearing potential if they have
    had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical
    profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical
    bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six
    weeks ago. In the case of oophorectomy alone, only when the reproductive status of
    the woman has been confirmed by follow up hormone level assessment is she
    considered not of child bearing potential.
    3. Patients with Type I or uncontrolled Type II diabetes.
    4. Patients with a history of long QT syndrome or whose QTc measured at Visit 101
    (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a
    central assessor. These patients should not be re-screened.
    5. Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 201.
    (These patients should not be re-screened)
    6. Patients who have a clinically significant laboratory abnormality at Visit 101.
    7. Patients who have clinically significant renal, cardiovascular (such as but not limited to
    unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial
    infarction), arrhythmia (see below for patients with atrial fibrillation), neurological,
    endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological
    abnormalities which could interfere with the assessment of the efficacy and safety of the
    study treatment.
    8. Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with
    persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months
    and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel
    blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at Visit 101
    and Visit 102 with a resting ventricular rate < 100/min. At Visit 101 the atrial fibrillation
    must be confirmed by central reading.

    For more Exclusion criteria, please refer to the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of COPD exacerbations (mild/moderate/severe) during 52 weeks of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 52
    E.5.2Secondary end point(s)
    •Time to first COPD exacerbation (mild/moderate/severe).
    •Rate and time to first moderate/severe COPD exacerbations.
    •Rate and time to first moderate to severe COPD exacerbation requiring:
    • systemic glucocorticosteroids during the treatment period
    • antibiotics during the treatment period
    • hospitalizations during the treatment period.
    • rehospitilisation within 30 days during the treatment period.
    •FEV1 (including morning pre-dose FEV1) and FVC on Day 1 and after 4, 12, 26, 38 and 52 weeks of treatment.
    •Standardized FEV1 AUC (0 – 12h), in a subset of patients.
    •Total score of the St. George’s Respiratory Questionnaire (SGRQ-C) after 4, 12, 26, 38 and 52 weeks of treatment
    •Mean use of rescue therapy over the 52 weeks treatment period.
    •Safety - ECG, laboratory tests, vital signs and adverse events
    •24-hour weighted mean urine cortisol, in a sub-set of patients.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 52
    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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA496
    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
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Croatia
    Czech Republic
    Denmark
    Egypt
    Estonia
    Finland
    France
    Germany
    Greece
    Guatemala
    Hong Kong
    Hungary
    Iceland
    India
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    Netherlands
    Norway
    Peru
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Turkey
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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.1.3Elderly (>=65 years) Yes
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2380
    F.4.2.2In the whole clinical trial 3332
    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)
    none
    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 Decision2013-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-15
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