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    The EU Clinical Trials Register currently displays   38958   clinical trials with a EudraCT protocol, of which   6398   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2009-013235-38
    Sponsor's Protocol Code Number:CQVA149A2307
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-19
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedLatvia - SAM
    A.2EudraCT number2009-013235-38
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebocontrolled
    study, to assess the long term safety of 52
    weeks treatment with QVA149 (110μg indacaterol / 50μg
    glycopyrrolate) in patients with moderate to severe Chronic
    Obstructive Pulmonary Disease (COPD)
    A.4.1Sponsor's protocol code numberCQVA149A2307
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma AG
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 596510
    D.3.9.3Other descriptive nameGlycopyrrolate
    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 INNINDACATEROL
    D.3.9.1CAS number 312753-06-3
    D.3.9.3Other descriptive nameIndacaterol Maleate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    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)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety/tolerability of 52 weeks of treatment with QVA149 (110μg
    indacaterol/50μg glycopyrrolate) once a day on adverse event reporting rate in patients
    with moderate or severe Chronic Obstructive Pulmonary Disease (COPD)
    E.2.2Secondary objectives of the trial
    1. To compare the safety of QVA149 with placebo over 52 weeks treatment based on vital
    signs, ECGs, laboratory evaluations.
    2. To compare the bronchodilator effect of QVA149 with placebo based on the mean FEV1
    at 15 and 45 minutes pre-dose at week 52.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients eligible for inclusion in this study have to fulfill all of the following criteria:
    1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form
    prior to initiation of any study-related procedure
    2. Patients with moderate to severe stable COPD (Stage II or Stage III) according to the
    [GOLD Guidelines 2008]
    3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten
    pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20
    years etc.)
    4. Patients with post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and
    post-bronchodilator FEV1/FVC < 0.7 at Visit 2
    (Post refers to 1 hour after sequential inhalation of 84 μg (or equivalent dose) of
    ipratropium bromide and 400 μg of salbutamol or equivalent dose of albuterol)
    5. Patients, according to daily electronic diary data between Visit 2 and Visit 3, with a
    total score of 1 or more on at least 4 of the last 7 days prior to Visit 3.
    E.4Principal exclusion criteria
    Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
    1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine
    pregnancy test).
    2. Women of child-bearing potential (WOCBP), defined as all women physiologically
    capable of becoming pregnant, including women whose career, lifestyle, or sexual
    orientation precludes intercourse with a male partner and women whose partners have
    been sterilized by vasectomy or other means, UNLESS they meet the following
    definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea OR 6
    weeks after surgical bilateral oophorectomy (with or without hysterectomy) OR are
    using one or more of the following acceptable methods of contraception:
    • surgical sterilization (e.g. bilateral tubal ligation),
    • hormonal contraception (implantable, patch, oral, IM) and copper coated IUD, if
    accepted by local regulatory authority and ethics committee,
    • double barrier method (diaphragm plus condom),
    • At the discretion of the investigator, total abstinence is acceptable in cases where
    the age, career, lifestyle, or sexual orientation of the patient ensures compliance
    • Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation
    methods) and withdrawal are not acceptable methods of contraception.
    Note: Reliable contraception should be maintained throughout the study.
    3. Patients requiring long term oxygen therapy (> 15h a day) on a daily basis for chronic
    4. Patients who have had a COPD exacerbation that required treatment with antibiotics or
    oral steroids or hospitalization in the 6 weeks prior to Visit 1 or between Visit 1 and
    Visit 3
    5. Patients who develop a COPD exacerbation during the period between Visits 1 and 3
    will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks
    after the resolution of the COPD exacerbation
    6. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
    Patients who develop an upper or lower tract infection during the screening period (up
    to Visit 3) will not be eligible, but will be permitted to be re-screened 4 weeks after the
    resolution of the respiratory tract infection)
    7. Patients with concomitant pulmonary disease, e.g., pulmonary tuberculosis (unless
    confirmed by chest x-ray to be no longer active) or clinically significant
    bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension.
    8. Patients with lung lobectomy, or lung volume reduction or lung transplantation.
    9. Patients who, in the judgment of the investigator , have a clinically relevant laboratory
    abnormality or a clinically significant condition such as (but not limited to)
    • unstable ischemic heart disease, left ventricular failure, history of myocardial
    infarction, arrhythmia (excluding chronic stable AF)
    • history of malignancy of any organ system (including lung cancer), treated or
    untreated, within the past 5 years whether or not there is evidence of local
    recurrence or metastases, with the exception of localized basal cell carcinoma of
    the skin
    • Uncontrolled hypo- or hyperthyroidism, hypokalemia or hyperadrenergic state
    • narrow-angle glaucoma
    • symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to
    severe renal impairment or urinary retention
    • any condition which might compromise patient safety or compliance, interfere
    with evaluation, or preclude completion of the study
    10. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil
    count > 600/mm3 (at Visit 2), or onset of symptoms prior to age 40 years.
    11. Patients with eczema, known high IgE levels or known positive skin prick test.
    12. Patients with allergic rhinitis who use H1 antagonists or intranasal corticosteroids
    intermittently (treatment with a constant dose is permitted)
    13. Patients with known history and diagnosis of alpha-1 antitrypsin deficiency
    14. Patients who are participating in the active phase of a supervised pulmonary
    rehabilitation programme
    15. Patients with Type 1 or uncontrolled Type II diabetes
    16. Patients contraindicated for treatment with, or having a history of
    reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar
    class or any component thereof:
    • anticholinergic agents
    • long and short acting beta-2 agonists
    • sympathomimetic amines
    17. Patients with a history of long QT syndrome or whose QTc measured at Visit 2
    (Fridericia method) is prolonged (450 ms for males and females) as confirmed by the
    central ECG assessor
    18. Patient who have a clinically significant abnormality on the screening or baseline ECG
    who in the judgment of the investigator would be at potential risk if enrolled into the
    study. These patients should not be re-screened
    E.5 End points
    E.5.1Primary end point(s)
    safety/tolerability of 52 weeks of treatment with QVA149 (110μg
    indacaterol/50μg glycopyrrolate)
    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 Yes
    E.6.13.1Other scope of the trial description
    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. 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 No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    End of trial detailed in protocol
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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.1.3Elderly (>=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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 339
    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)
    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 Decision2010-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-01
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