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    Summary
    EudraCT Number:2007-004684-22
    Sponsor's Protocol Code Number:CQAB149B2318
    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:2007-11-06
    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 number2007-004684-22
    A.3Full title of the trial
    An exploratory, double-blind, randomized, placebocontrolled, 2-way cross-over study to assess the effect of repeat-dose inhaled indacaterol maleate (300 mcg) on dynamic and static lung hyperinflation, subjective breathlessness and health status in patients with COPD.
    A.4.1Sponsor's protocol code numberCQAB149B2318
    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 312753-06-3
    D.3.9.2Current sponsor codeQAB149
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Information not present in EudraCT
    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 evaluate the effect of 2 weeks treatment with inhaled QAB149 (300 mcg) on isotime and peak exercise IC in patients with COPD.
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of a single dose treatment with inhaled QAB149 (300 mcg) on isotime and peak exercise IC in patients with COPD.
    • To evaluate the effect of 2 weeks treatment with inhaled QAB149 (300 mcg) on static (resting) IC in patients with COPD.
    • To evaluate the effect of 2 weeks treatment with inhaled QAB149 (300 mcg) on trough bronchodilatory efficacy FEV1 in patients with COPD.
    • To evaluate the effect of 2 weeks treatment with inhaled QAB149 (300 mcg) on chronic activity-related breathlessness (baseline and transition dyspnoea indices) in patients with COPD compared to placebo.
    • To evaluate the effect of 2 weeks treatment with inhaled QAB149 (300 mcg) on dyspnoea (measured with the Borg CR10 Scale®) in patients with COPD compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female (see exclusion criteria 8 below) patients with COPD, aged 40-80 years, with a smoking history of at least 20 pack years (i.e. smokers or ex-smokers).
    2. Prior to administration of any study procedures, all subjects must understand and provide written informed consent. Patients must be able to communicate well with the investigator, to understand and comply with the requirements of the study
    3. Diagnosis of COPD according to GOLD criteria
    4. Body mass index (BMI) must be within the range of 18 to 32 kg/m2. Patients must weigh at least 50 kg to participate in this study.
    5. Post-bronchodilator* 40% ≤ FEV1 at screening ≤ 80% of the predicted normal value
    6. Post-bronchodilator* FEV1/FVC < 70%
    7. Increase in FEV1 from Pre-bronchodilator to Post-bronchodilator assessment of at least 5%
    8. Demonstrated plethysmographic functional residual capacity > 120% predicted normal
    9. No history of concomitant lung disease such as asthma, carcinoma, active TB or prior thoracic surgery. No requirement for long term oxygen treatment or history of lung reduction surgery. No medical conditions that would interfere with the performance of spirometry or cardiopulmonary exercise testing, serum CPK levels must be in the normal range as measured by point-of-care or lab assay at screening and prior to all protocol specified exercise testing.
    10. Male patients must be using a double-barrier local contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit, and refrain from fathering a child in the three (3) months following last study drug administration.
    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 human chorionic gonadotrophin laboratory test (> 5 mIU/mL)
    2. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 2 or during the run-in period
    3. Patients requiring oxygen therapy or who experience oxygen desaturation to <80% during cycle exercise on room air according to the methodology used by the investigator and in the opinion of the investigator should not participate in the study.
    4. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2. Patients who develop a respiratory tract infection prior to randomization must discontinue from the trial, but may be permitted to re-enroll at a later date (at least 6 weeks after the end of the respiratory tract infection)
    5. Patients with contra-indications of cardiopulmonary exercise testing:
    6. Patients with significant (investigator evaluation) concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis
    7. Patients with a history of asthma indicated
    8. Women of child-bearing potential
    9. Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition which in the investigator’s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
    10. Any patient with lung cancer or a history of lung cancer
    11. 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).
    Localized basal cell carcinoma (without metastases) of the skin is acceptable. Patients
    with a history of cancer (excluding lung cancer) and 5 years or more disease free survival
    time may be included in the study at the investigator’s discretion on a case-by-case basis
    12. History of immunodeficiency diseases, including a positive HIV (ELISA and Western
    blot) test result.
    13. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
    14. Patients with a history of long QT syndrome or whose QTc interval (Bazett’s) measured at Screening or Visit 4 is prolonged: > 430 ms (males) or > 450 ms (females) as assessed by the investigator. Patients who fail the screening ECG (with the exception of machine failures) should not be re-screened.
    15. Patients with a history of hypersensitivity to any of the study drugs or to drugs with
    similar chemical structures including untoward reactions to sympathomimetic amines or
    inhaled medication or any component thereof
    16. Patients who have had treatment with investigational drugs at the time of enrollment, or
    within 30 days or 5 half-lives prior to screening.
    17, 18, 19 Disallowed medications including treatments for COPD and allied conditions and other conditions: (please see protocol for washout times prior to screening and excluded meds, meds allowed if stabilized, and other excluded medications)
    20. Patients unable to successfully use a dry powder inhaler device or perform spirometry
    measurements
    E.5 End points
    E.5.1Primary end point(s)
    Changes in Forced Expirtory Volume in 1 second, Changes in Forced Vital Capacity, Changes in Inspiratory Capacity, Changes in Functional Residual Capacity, Changes in Total Lung Capacity, Changes in Residual Volume, Changes in Dynamic Inspiratory Capacity. Changes in the above within treatment periods and between treatment periods.
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 visit of Last subject undergoing the trial is the definition of the end of 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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-11-06. Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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 Decision2008-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-05
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