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    Summary
    EudraCT Number:2009-011539-10
    Sponsor's Protocol Code Number:CQMF149A2210
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-28
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-011539-10
    A.3Full title of the trial
    A randomized, multi-center, parallel group, double blind, study to assess the safety of QMF Twisthaler® (500/400μg) and mometasone furoate Twisthaler® (400μg) in adolescent and adult patients with persistent asthma.
    A.4.1Sponsor's protocol code numberCQMF149A2210
    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 nameQMF Twisthaler 500/400μg
    D.3.2Product code QMF149
    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 INNIndacaterol maleate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMometasone furoate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Asmanex Twisthaler 400 micrograms Inhalation Powder
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMF Twisthaler 400µg
    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 INNMometasone furoate
    D.3.9.1CAS number 83919-23-7
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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 compare the rate of serious asthma exacerbations resulting in hospitalization, intubation or death in patients treated with QMF 500/400 μg or MF 400 μg.
    E.2.2Secondary objectives of the trial
    • To compare the rate of asthma exacerbations that require systemic corticosteroid use
    • To evaluate the safety of QMF versus MF in terms of other adverse events, laboratory values, vital signs and ECG
    • To evaluate the benefit of QMF versus MF as measured by spirometry data and ediary data
    • To evaluate the effect of QMF on asthma control as measured by the Asthma Control Questionnaire (ACQ) as supportive evidence of treatment efficacy.

    Exploratory objectives:
    • To explore the impact of QMF on work productivity, as measured by the WPAI-Asthma questionnaire, and on asthma-related medical resource utilization
    • To collect utilities (derived from EQ-5D) experienced by patients during the study
    • To collect pharmacokinetic data in a subset of the patient population
    • To collect pharmacogenetic data in consenting patients*
    *Samples will only be collected depending upon regulatory and/or IRB/IEC/REB approval and/or country participation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must give written informed consent before any study related activity is performed Patients below the legal age of consent are required to have the Informed Consent Form signed by the patient’s parent/guardian; adolescents should also sign an assent form
    2. Male and female adult and adolescent patients aged ≥12 years (or ≥18 years depending upon regulatory and/or IRB/IEC/REB approval and/or country participation) and ≤ 70 years
    3. Patients with a documented diagnosis of persistent asthma (according to GINA guidelines) for a period of at least 6 months prior to Visit 1 and who are currently treated with or qualify for treatment (according to asthma treatment guidelines) with both ICS and LABA combination.
    4. Patients demonstrating an increase in FEV1 of ≥12% or ≥200 mLs within 30 minutes after administration of β2-agonist (SABA) as per site protocol. Alternatively, patients may have documentation of reversibility within the last 12 months
    5. Patients with an FEV1 ≥50% of predicted normal at Visit 2. This criterion for FEV1 will have to be demonstrated after all restricted medications have been withheld for
    appropriate intervals (washout period of at least 6 hours for a short acting β2-agonist and a minimum of 24 hours for a long acting β2-agonist).
    E.4Principal exclusion criteria
    1. Pregnant or nursing (lactating) women confirmed by a positive serum hCG laboratory test (> 5 IU/ml)
    2. Women of child-bearing potential (WOCBP), 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
    3. Patients who have smoked or inhaled tobacco products within the 3 month period prior to Visit 2, or who have a smoking history of greater than 10 pack years
    4. Patients with a previous diagnosis of COPD
    5. Patients who have had a asthma attack/exacerbation requiring hospitalization within 1 month prior to Visit 3
    6. Patients who have had an emergency room visit for an asthma attack/asthma exacerbation within 1 month prior to Visit 3
    7. Patients who have had a respiratory tract infection or asthma worsening within 1 month prior to Visit 3.
    8. Patients who have ever required ventilator support for respiratory failure secondary to asthma
    9. Patients with evidence upon visual inspection of clinically significant oropharyngeal candidiasis at baseline or earlier, with or without treatment.
    10. Patients with any chronic conditions affecting the respiratory tract or chronic lung diseases which may interfere with the study evaluation or optimal participation in the study
    11. Patients with diabetes Type I or uncontrolled diabetes Type II
    12. Patients who have a clinically relevant laboratory abnormality or a clinically significant condition that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
    13. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
    14. Patients with a history of long QT syndrome or whose QTc interval (Fridericia) measured at Visit 2 or Visit 3 is prolonged: >450 ms as assessed by the central ECG interpretation (Visit 2) or investigator’s interpretation of the pre-dose ECGs (Visit 3). Patients who fail the screening ECG (with the exception of machine failures) should not be re-screened.
    15. History of myocardial infarction within the previous 12 months; uncontrolled or unstable angina pectoris or arrhythmia (excluding chronic atrial fibrillation). Known history of congestive heart failure or known LVEF < 45%. Implanted cardiac pacemaker or defibrillator
    16. Patients with a history of hypersensitivity to any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
    17. Patients who do not maintain regular day/night, waking/sleeping cycles
    18. Patients who have had live attenuated vaccinations within 30 days prior to screening visit or during the run-in period.
    19. Patients using prohibited medications or patients who cannot adhere to medication washouts.
    20. Maintenance Immunotherapy (desensitization) for allergies is allowed if maintenance dose has been administered for at least 3 months prior to Visit 2, and is expected to remain unchanged throughout the course of the study
    21. Other excluded medications:
    a. Non-potassium sparing diuretics (unless used in combination with potassium
    conserving drugs) or with a potassium supplement for which there is adequate
    documentation of the subject’s use taken together with a diuretic
    b. Non-selective systemic beta-blocking agents
    c. Drugs with potential to significantly prolong the QT interval; Cardiac antiarrhythmics
    Class Ia (e.g., disopyramide, procainamide, quinidine); Class III (e.g.,
    amiodarone, dofetilide, ibutilide, sotalol), the antihistamines astemizole and,
    mizolastin, macrolides and antipsychotics (e.g., haloperidol, thioridazine)
    d. Tricyclic antidepressants and monoamino-oxidase inhibitors
    e. Stong inhibitors of cytochrome P4503A4 (e.g. ketoconazole)
    22. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives prior to Visit 2, whichever is longer
    23. Patients unable to use a dry powder inhaler device, metered dose inhaler or perform spirometry measurements
    24. Patients with a known history of non-compliance to medication or who are unable or unwilling to use Electronic Peak Flow with e-diary device
    25. No person directly associated with the administration of the study may participate as a study subject. No family member of the investigational study staff may participate in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety endpoint is the time to the first serious asthma exacerbation during the study. The hazard risk of primary endpoint will be compared between treatment groups.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    LPLV
    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 months10
    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 months10
    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 Yes
    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) Yes
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 1500
    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)
    Expected normal treatment
    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 Decision2009-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-06
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