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    Summary
    EudraCT Number:2007-001005-16
    Sponsor's Protocol Code Number:CQAB149B2338
    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:2007-07-11
    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 number2007-001005-16
    A.3Full title of the trial
    A 26 week treatment, randomized, multi center, double blind, double dummy, parallel-group study to assess the safety of indacaterol (300 and 600 µg o.d.) in patients with moderate to severe persistent asthma, using salmeterol (50 µg b.i.d.) as an active control
    A.4.1Sponsor's protocol code numberCQAB149B2338
    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 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 Serevent Diskus
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSerevent Diskus
    D.3.4Pharmaceutical form Inhalation powder
    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 INNSalmeterol
    D.3.9.1CAS number 89365-50-4
    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) 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
    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
    moderate and severe persistent asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    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 safety of indacaterol 300 and 600 μg o.d over 26 weeks, in patients with moderate to severe persistent asthma who are receiving background therapy with inhaled corticosteroid. The assessment of safety will include all safety measurements including adverse events and asthma exacerbations, however, particular attention will be paid to the key safety variables for this class of drug namely, serum potassium and glucose, heart rate, blood pressure, and QTc.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of indacaterol 300 and 600 μg o.d. on pulmonary function assessments (FEV1 and FVC) over 26 weeks.
    To evaluate the effect of indacaterol (300 and 600 µg o.d.) on asthma exacerbation rates over 26 weeks.
    To characterize long term exposure and PK to indacaterol 300 and 600 µg o.d using sparse sampling and application of a population PK and PK/PD model in order to analyze the effects of age, gender and race on PK variables.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male and female patients aged ≥ 18 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. In the case of patients below the legal age of consent, the Informed Consent Form must also be signed by the patient’s parent / guardian.
    2.Patients with moderate to severe persistent asthma, diagnosed according to GINA guidelines (Updated 2006) and who additionally meet the following criteria:
    a)Patients who have used treatment with a bronchodilator, either regularly or on-demand, and who have used a daily dose of at least 100 µg BDP (HFA) or equivalent (up to the maximum daily dose as recommended in the package leaflet) for at least one month prior to Visit 1. In addition patients must have been taking a stable dose for at least one month prior to Visit 1.
    b)Patients whose FEV1 is ≥50% of the predicted normal value for the patient at both Visit 1 and Visit 2. This criterion for FEV1 is to be demonstrated after an appropriate washout period for all bronchodilators (e.g. at least six hours for short-acting bronchodilators and 48 hours for long acting bronchodilators and formoterol) prior to the evaluation.
    c)Patients with documented (in the previous 6 months) or who demonstrate (prior to visit 2) a ≥12% and at least 200 ml increase in FEV1, over their pre-bronchodilator value within 30 minutes after inhaling a total of 200/180 µg salbutamol/albuterol (i.e. two inhalations), demonstrated after an appropriate washout period for all bronchodilators prior to the evaluation.
    E.4Principal exclusion criteria
    -Pregnant or nursing (lactating) women
    -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 post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m OR are using one or more of the following acceptable methods of contraception(surgical sterilization, hormonal contraception, double-barrier methods). For females aged 12 to 17 years acceptable methods of contraception may include total abstinence at the discretion of the investigator. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation
    -Patients who have used inhaled tobacco products within the 12 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. Use of chewing tobacco or snuff is acceptable prior to and during the study.
    -Patients who suffer from COPD as diagnosed by the GOLD guidelines (2006).
    -Patients who have had emergency room treatment for an acute asthma attack in the 6 weeks prior to Visit 1 or who have been hospitalized for an acute asthma attack in the 6 months prior to Visit 1, or at any time between Visit 1 and Visit 2.
    -Patients who have had a respiratory tract infection within 6-weeks prior to Visit 1. Patients who develop a respiratory tract infection between Visit 1 and 2 must discontinue from the trial, but may be permitted to re-enroll at a later date
    -Patients with diabetes Type I or those with uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1C >8.0% measured at Visit 1.
    -Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically significant condition or a clinically relevant laboratory abnormality such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable atrial fibrillation), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state, that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
    -Any patient with active cancer or a history of cancer with less than 5 years disease free survival time. Localized basal cell carcinoma (without metastases) of the skin is acceptable. Patients with a history of cancer and 5 years or more disease free survival time may be included in the study by agreement with Novartis H.Q.personnel on a case-by-case basis.
    -Patients with a history of long QT syndrome, or whose QTc interval is prolonged to > 450 ms (males) or > 470 ms (females).
    -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.
    -Patients who do not maintain regular day/night, waking/sleeping cycles
    -Patients who have had live attenuated vaccinations within 30 days prior to Visit 1 or during the run-in period.
    -Patients with a known history of non-compliance to medication or who are unable or unwilling to complete a patient daily diary.
    -Treatments for asthma 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 (bromide): 7 days.
    b)Short acting anti-cholinergics: 8 h
    c)Fixed combinations of 2-agonists and inhaled corticosteroids: 48 h
    d)Long-acting 2-agonists: 48 h
    e)Short acting 2-agonists: 6 h
    f)Theophylline and other xanthines: 7 days
    g)Parenteral or oral corticosteroids: 3 months.
    16.Treatments for asthma: The following medications should not be used unless they have been stabilized for at least one month prior to Visit 1:
    Cromoglycate, nedocromil, ketotifen, omalizumab, inhaled corticosteroids and leukotriene antagonists.
    -Other excluded medications:
    a)Non-potassium sparing diuretics
    b)All beta-blocking agents
    c)Cardiac anti-arrhythmics Class Ia, Class III and any drug with potential to significantly prolong the QT interval.
    d)Tricyclic antidepressants and monoamino-oxidase inhibitors. e)Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives prior to Visit 1, whichever is longer
    -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 of this study is to evaluate the safety of indacaterol 300 µg and 600 µg o.d. in patients with moderate to severe persistent asthma following 26 weeks of treatment. The assessment of safety will include all safety measurements including adverse events and asthma exacerbations, however, particular attention will be paid to the key safety variables for this class of drug namely, serum potassium and glucose, heart rate, blood pressure, and QTc.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    additionally double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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 years0
    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 years0
    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 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 2007-07-11. 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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 750
    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 Decision2007-08-07
    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
    P.Date of the global end of the trial2008-08-20
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