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    Summary
    EudraCT Number:2009-014551-80
    Sponsor's Protocol Code Number:1268.16
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-014551-80
    A.3Full title of the trial
    Randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of 6 weeks of oral BI 671800 ED 400 mg b.i.d., Montelukast 10 mg q.d., or placebo in symptomatic asthma patients on fluticasone propionate MDI
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code number1268.16
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorBOEHRINGER ING.
    B.1.3.4CountryItaly
    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.3.2Product code BI 671800 ED
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1093112-14-1
    D.3.9.2Current sponsor codeBI 671800 ED
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Singulair tablets, 10 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMerck & Co. Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMontelukast
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with symptomatic asthma on inhaled corticosteroids
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10049106
    E.1.2Term Asthma chronic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the efficacy, safety and tolerability of BI 671800 ED 400 mg b.i.d. compared to placebo or montelukast 10 mg q.d., given for 6 weeks as add-on therapy to fluticasone propionate MDI (50 micrograms 2 puffs b.i.d.) in symptomatic asthmatic patients.
    E.2.2Secondary objectives of the trial
    Efficacy: Morning trough forced expiratory volume in one second (FEV1) % predicted, FEV1, forced vital capacity (FVC), Forced expiratory flow (FEF)25-75%, Peak FEV1, Peak FVC, FEV1 area under the curve (AUC)0-3h, FVC AUC0-3h, asthma control questionnaire (ACQ) and sub-scores, standardised asthma quality of life questionnaire (AQLQ(S)), daily symptom scores (a.m. and p.m.), weekly means of daily puffs of rescue medication usage, peak expiratory flow (PEF) and FEV1, asthma symptom-free days, asthma controlled weeks, asthma exacerbations, fractional exhaled Nitric Oxide (FeNO), total IgE and eosinophilic cationic protein (ECP). Pharmacokinetics:Population pharmacokinetics (PK) from plasma concentrations of BI 671800 sampled during the treatment period (total of two samples). Pharmacogenomics: Unspecified pharmacogenomic (PGx) testing. Safety: Adverse events (AEs), routine laboratory, physical examinations, 12 lead electrocardiogram (ECG), vital signs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject has to meet the following inclusion criteria in order to be eligible for randomisation: 1. Signed informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions. 2. All patients must have a diagnosis of asthma by a physician at least 3 months prior to screening Visit 2. The diagnosis of asthma must be according to the 2008 Global Initiative for Asthma (GINA) Guidelines and must meet the following spirometric criteria: a) Pre-bronchodilator clinic measured FEV1 >= 60% and <= 85% of predicted normal (calculated according to modified NHANES measured >= 6 hours after the last use of salbutamol/albuterol rescue medication on the day of randomisation. b) FEV1 reversibility: Improvement in FEV1 >= 12% above baseline and an absolute change of at least 200 ml within 15-30 minutes after administration of 400 micrograms salbutamol HFA MDI. Reversibility testing must be performed during the run-in period at Visit 2 and may be repeated once at Visit 3 if reversibility is not determined at Visit 2. Reversibility testing must not occur on the day of randomisation. 3. The patient must be on at least iCS at a stable dose for at least 3 months prior to screening Visit 2. 4. Diagnosis of asthma must have been made before the age of 40 years. 5. Patient must be symptomatic with an ACQ value of >= 1.5 on the day of randomisation. 6. Male or female patients 18 to 65 years of age inclusive. 7. Body Mass Index (BMI) between 18 >= and <= 35 8. Non-smokers or ex-smokers with a cigarette smoking history of <= 10 pack-years (and smoking cessation for at least one year prior to enrolment). Patients must have a negative urinary cotinine at screening visit 2. Pack years = (Number of cigarettes/day x years of smoking)/20 cigarettes/pack. 9. Patients must be able to perform technically acceptable pulmonary function tests and electronic PEF measurements, and must be able to maintain records (AM2+) during the study period as required in the protocol. 10. Patients must be able to properly use or be trained in the proper use of an MDI.
    E.4Principal exclusion criteria
    1.Significant pulmonary disease other than asthma (or allergic rhinitis) or other medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator result in any of the following: a) Put the patient at risk because of participation in the study, b) Influence the results of the study, c) Cause concern regarding the patient`s ability to participate in the study. 2.Patients with a clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis at screening, if the abnormality defines a significant disease as defined in exclusion criterion No. 1. Patients will not be randomised if they have an AST, ALT, &#947;GT, TBIL or INR greater than 1.5 fold the upper limit of normal (ULN) at Screening Visit 2. Laboratory testing may be repeated once during the run-in phase. 3. Hospitalisation for asthma exacerbation within 3 months or intubation for asthma within 3 years of screening Visit 2. 4. Patient partially controlled (ACQ6 > 1.5) on iCS plus any other asthma controller therapy (methylxanthines, cromones, LABA, LTRA, including medication wash-out) at Visit 2. 5. Respiratory tract infection or asthma exacerbation in the 4 weeks prior to Screening Visit 2 or during the run-in period. In the case of URTI (without asthma exacerbation) during run-in period, patients can be pre-screened again 4 weeks after the resolution of the infection. 6. Thoracotomy with pulmonary resection. Thoracotomy for other reasons should be assessed under exclusion criterion No. 1. Any of the following safety net criteria are met during the run-in period (from screening to randomisation) a) In clinic FEV1% predicted pre-bronchodilator less than 40%; b) More than 12 puffs rescue salbutamol HFA MDI per day for more than 2 consecutive days; c) Exacerbation of asthma Previous participation in this study (receipt of randomised treatment) or active participation in a current interventional study. 9. Significant alcohol or drug abuse within past 2 years of screening Visit 2. See exclusion criterion No.1. 10. Pregnant or nursing women. 11. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. Effective methods of birth control include established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier method of contraception: condom or occlusive cap with spermicidal foam/gel/film/cream/suppository or male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). 12. Patients with known hypersensitivity to any component of the investigational treatment (see Section 4.1.1) or salbutamol or fluticasone propionate MDI or montelukast components. 13.Patients who have been treated with any of the medications in the given interval prior to screening Visit 2 (see protocol section 3.3.2). 14.Patients receiving CYP2C8 substrates such as amiodarone, amodiaquine, paclitaxel, rosiglitazone, pioglitazone and repaglinide or CYP2C9 such as warfarin, tolbutamide, phenytoin, losartan and acenocoumarol will be excluded. 15. Patients with a risk for prolonged QT interval effects including: a) A marked baseline prolongation of QTc interval (demonstration of a QTc interval > 450 ms with confirmation on a repeat ECG); b) A history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family, history of Long QT Syndrome, etc); c) Patients receiving concomitant medications known to prolong the QT/QTc interval.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is FEV1 % predicted trough change from baseline after 6 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 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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 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
    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) No
    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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 207
    F.4.2.2In the whole clinical trial 345
    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 Decision2010-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
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