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    Summary
    EudraCT Number:2008-008748-26
    Sponsor's Protocol Code Number:CQAB149B2312
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-008748-26
    A.3Full title of the trial
    A phase IIIb randomized, double-blind, placebo controlled, 2 period crossover, multicenter study to assess the effect of indacaterol (150 μg o.d.) on exercise endurance in patients with moderate to severe chronic obstructive pulmonary disease (COPD)
    A.4.1Sponsor's protocol code numberCQAB149B2312
    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 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 support
    B.4.2Country
    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
    D.3.2Product code QAB149
    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.3.8INN - Proposed INNIndacaterol
    D.3.9.1CAS number 753498-25-8
    D.3.9.2Current sponsor codeQAB149 [maleate]
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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
    COPD (chronic obstructive pulmonary disease)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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 demonstrate the superiority of indacaterol (150 μg o.d.) in patients with moderate to severe COPD as compared to placebo with respect to exercise endurance time (measured through constant-load cycle ergometry testing) after 3 weeks treatment.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of indacaterol (150 μg o.d.) compared to placebo on trough (i.e. 24h post dose) Inspiratory Capacity (IC) after 3 weeks of treatment
    2. To evaluate the effect of indacaterol (150 μg o.d.) compared to placebo on trough (i.e. 24h post dose) FEV1 after 3 weeks of treatment
    3. To evaluate the effects of indacaterol (150 μg o.d.) compared to placebo on pulmonary function tests after 3 weeks of treatment whilst:
    • The patient is not exercising (i.e. the patient is at rest)
    • The patient is exercising
    4. To evaluate the effect of indacaterol (150 μg o.d.) compared to placebo on exertional dyspnea (Borg CR10 Scale®) during exercise after 3 weeks treatment.
    5. To evaluate the effect of indacaterol (150 μg o.d.) compared to placebo on leg discomfort (Borg CR10 Scale®) during exercise after 3 weeks treatment
    6. To assess the effect of indacaterol (150 μg o.d.) on patient activity measured using an actigraphy device, as compared with placebo after 3 weeks treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female adults aged ≥40 years who have signed an Informed Consent Form prior to initiation of any study-related procedure
    2. Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the (GOLD Guidelines, 2007), Appendix 3 and additionally including:
    a. Smoking history of at least 10 pack years.
    b. Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value at screening.
    c. Post-bronchodilator FEV1/FVC < 70% at screening.
    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 serum
    2. Women of child-bearing potential, 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 postmenopausal:
    12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous
    amenorrhea with serum FSH levels >40 mIU/mL or are using one or more of the
    following acceptable methods of contraception:
    - surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
    - hormonal contraception (implantable, patch, oral)
    - double-barrier methods (any double combination of: IUD, male or female condom
    with spermicidal gel, diaphragm, sponge, cervical cap).
    3. Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid
    treatment and/or antibiotics and/or hospitalization in the 6 weeks prior to screening (Visit 2). In the event of an exacerbation occurring during the run-in period, the patient must discontinue from the study. The patient may re-enroll once the inclusion/exclusion criteria have been met.
    4. Patients whose body mass index is less than 15 or greater than 40 kg/m2.
    5. Patients requiring oxygen therapy for chronic hypoxemia (excluding acute COPD
    exacerbation). This is typically patients requiring oxygen therapy more than 15 h per day delivered by home oxygen cylinder or concentrator.
    6. Patients with a Wmax value < 20 W (as determined by the incremental cycle endurance test) at Visit 2
    7. Patients who have had a respiratory tract infection within 6 weeks prior to screening (Visit 2). Patients who develop a respiratory tract infection between prescreening (Visit 1) and randomization (Visit 3) must discontinue from the trial, but may be permitted to re-enroll at a later date once inclusion/exclusion criteria have been met (at least 6 weeks after the start of the respiratory tract infection)
    8. Patients with contra-indications of cardiopulmonary exercise testing as described in the protocol.
    9. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
    10. Patients with a history of asthma indicated by (but not limited to):
    - onset of respiratory symptoms suggestive of asthma prior to age 40 years
    - a history of a diagnosis of asthma
    11. Patients with Type I diabetes or uncontrolled Type II diabetes including patients with a history of blood glucose levels consistently outside the normal range or HbA1C > 8.0% of total Hb measured at screening (Visit 2)
    12. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) those described in the protocol.
    13. Any patient with lung cancer or a history of lung cancer
    14. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases).
    15. Patients with a history (or family history) of long QT syndrome or whose QTc interval (Fridericia’s) measured at screening (Visit 2) is prolonged: > 450 ms (males) or > 470 ms (females) as assessed by the investigator.
    16. Patients who have had live attenuated vaccinations within 30 days prior to screening visit (Visit 2) or during the run-in period.
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate the superiority of indacaterol (150 μg o.d.) in patients with moderate to severe COPD as compared to placebo with respect to exercise endurance time (measured through constant-load cycle ergometry testing) after 3 weeks treatment.
    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 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 No
    E.8.1.6Cross over Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    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 days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 96
    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 Decision2009-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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