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    Summary
    EudraCT Number:2006-001954-28
    Sponsor's Protocol Code Number:CQAB149B2334
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-03
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-001954-28
    A.3Full title of the trial
    A 52-week treatment, multicenter, randomized, double-blind, double dummy, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (300 & 600 µg o.d.) in patients with chronic obstructive pulmonary disease, using formoterol (12 µg b.i.d.) as an active control
    A.4.1Sponsor's protocol code numberCQAB149B2334
    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 SponsorNovartisPharma 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.3.11 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.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 Foradil
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis s.r.o., Praha, ČR
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    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 nameForadil
    D.3.2Product code FOR258
    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.3.11 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
    D.8 Placebo: 2
    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 8.1
    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 indacaterol (300 & 600 µg o.d. via SDDPI) superiority in patients with COPD as compared to placebo with respect to 24 h post dose (trough) FEV1 after 12 weeks of treatment
    E.2.2Secondary objectives of the trial
    KEY:Effect of indacaterol (300 & 600 µg o.d.) on % ‘days of poor control’ over 52 weeks, versus placebo.
    Effect of indacaterol versus placebo on the following:
    St Georges Respiratory Questionnaire, after 12 weeks
    Time to first COPD exacerbation over 52 weeks
    QoL after 4, 8, 12, 24, 44 and 52 weeks.
    COPD exacerbation rates over 52 weeks
    TDI focal score after 4, 8, 12, 24, 44 and 52 weeks.
    Trough FEV1 measured on Day 2 and after 52 weeks.
    Spirometry at all time points with respect to early, peak and trough response.
    Morning and evening PEF, clinical symptoms and use of rescue medication over 52 weeks.
    •Long term tolerability and safety (ECG, laboratory tests, blood pressure, and adverse events).
    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 (2005) and:
    a)Smoking history of at least 20 pack years
    b)Post-bronchodilator FEV1 < 80 % and ≥30 %of the predicted normal value
    c)Post-bronchodilator FEV1/FVC < 70%
    (Post referes to within 30 min after inhalation of 400 µg of salbutamol
    E.4Principal exclusion criteria
    1. Pregnant or nursing women 2. Women of child-bearing potential UNLESS they meet a pre-defined definition of post-menopausal, OR are using one or more pre-specified acceptable methods of contraception: 3. Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or during the run-in period. 4. Patients requiring oxygen therapy for chronic hypoxemia (excluding acute COPD exacerbation). This is typically patients requiring oxygen therapy >15h per day delivered by home oxygen cylinder or concentrator. 5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. 6. Patients with concomitant pulmonary disease including a history of lung cancer, pulmonary tuberculosis or clinically significant bronchiectasis. 7. Patients with a history (up to and including Visit 1) of asthma indicated by (but not limited to): a) Blood eosinophil count > 400/mm3 b) Onset of symptoms prior to age 40 years. 8. Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1C > 6.5% of total Hb. 9. 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) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any 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 other 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. 11. Patients with a history of long QT syndrome or whose QTc interval(Bazett’s) measured at Visit 1 or Visit 3 is prolonged to > 450 ms (males) or > 470 ms (females). 12. 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. 13. Patients who do not maintain regular day/night, waking/sleeping cycles 14. Patients who have had treatment with other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 15. Patients who have had live attenuated vaccinations within 30 days prior to Visit 1 and during the run-in period. (Influenza vaccination is acceptable provided it is not administered within 48 h prior to Visits 1, 2 or 3). 16. Treatments for COPD and allied conditions: the following medications must not be used prior to Visit 1 for at least the minimum washout period specified below or at any time during the study: a) The long acting anti-cholinergic agent tiotropium: 7 days b) Short acting anti-cholinergics: 8 h c) Fixed combinations of beta-2-agonists and inhaled corticosteroids: 48 h (Patients taking fixed dose combination therapy must switch to inhaled corticosteroid as monotherapy plus salbutamol/albuterol as rescue therapy) d) Fixed combination of beta-2-agonists and inhaled anticholinergics: 8h e)Long-acting beta-2-agonists: 48 h f) Short acting beta-2-agonists (other than those prescribed in the study): 6 h g) Theophylline and other xanthines: 1 week h) Parenteral or oral corticosteroids: 1 month 17. Treatments for COPD and allied conditions: The following medications should not be used unless they have been stabilized: a) Cromoglycate, nedocromil, ketotifen, inhaled or nasal corticosteroids and leukotriene antagonists - at least one month prior to Visit 1. b) Antihistamines (excluding those in 18c below) - at least 5 days prior to Visit 1. 18. Other excluded medications: a) Non-potassium sparing diuretics (unless administered as a fixed dose combination with a potassium sparing diuretic). b) Beta-blocking agents c) Cardiac anti-arrhythmics Class Ia (e.g., disopyramide, procainamide, quinidine), Class III (e.g., amiodarone, dofetilide, ibutilide, sotalol), terfenadine, astemizole, mizolastin and any drug with potential to significantly prolong the QT interval. d) Tricyclic antidepressants and monoamino-oxidase inhibitors. [Fluoxetine or any other selective serotonin uptake receptor inhibitor may only be permitted if the patient’s treatment regimen has been stable for at least 1 month prior to Visit 2 and they present with a current and historically normal ECG] 19. Patients unable to use a dry powder inhaler device or perform spirometry measurements.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to determine if indacaterol 600 µg is superior to placebo and indacaterol 300 µg is superior to placebo with respect to 24 hour post dose (trough) FEV1 in patients with COPD following 12 weeks of 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 Yes
    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 Yes
    E.6.13Others Information not present in EudraCT
    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) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA159
    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 years1
    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 years1
    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 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 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 929
    F.4.2.2In the whole clinical trial 1716
    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 Decision2006-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-21
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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