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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-014551-80
    Sponsor's Protocol Code Number:1268.16
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-15
    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 ConcernedAustria - BASG
    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.4.1Sponsor's protocol code number1268.16
    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 Ingelheim Pharma GmbH Co KG
    B.1.3.4CountryGermany
    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 nameBI 671800 ED 100 mg
    D.3.2Product code BI 671800 ED 100 mg
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current 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 mg
    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.3.1Product nameMontelukast
    D.3.4Pharmaceutical form Capsule
    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 SODIUM
    D.3.9.1CAS number 151767-02-1
    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
    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 placeboCapsule
    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
    Symptomatic asthmatic patients on inhaled corticosteroids
    MedDRA Classification
    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 μg 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, 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).
    - PK: Population PK from plasma concentrations of BI 671800 sampled
    during the treatment period (total of 2 samples)
    - Pharmacogenomics: Unspecified pharmacogenomic (PGx) testing
    - Safety: AEs, routine laboratory,
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent prior to any study procedures, which includes medication washout and restrictions. 2. Diagnosis of asthma by a physician at least 3 months prior to Visit2. The diagnosis must be according to the 2008 GINA Guidelines and must meet the following spirometric criteria: a) Pre-bronchodilator clinic measured FEV1≥60% and ≤85% predicted normal (modified NHANES measured ≥6hours 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 200ml within 15-30 minutes after 400μg salbutamol HFA MDI. Reversibility testing must be performed during the run-in at Visit2 and may be repeated once at Visit3. It must not occur on the day of randomisation.
    3. Patient must be on at least iCS at a stable dose for at least 3 months and at a stable dose for at least 6 weeks prior to screening Visit2. 4. Diagnosis of asthma made before the age of 40 years. 5. Patient must be symptomatic with an ACQ≥1.5 on the day of randomisation. 6. Male or female patients 18 to 65 yrs of age inclusive. 7. BMI between 18≥and≤35. 8. Non-smokers or ex-smokers with 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 visit 2. 9. Able to perform technically acceptable pulmonary function tests and electronic PEF measurements, and must be able to maintain records (AM2+®).
    E.4Principal exclusion criteria
    1. Significant pulmonary disease other than asthma or other medical conditions that may put the patient at risk, influence the results of the study, cause concern regarding the patient’s ability to participate in the study. Patients with malignancy for which patient has undergone resection/radiation/chemotherapy within past 5yrs. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed. 2. Clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis at screening, if the abnormality defines a significant disease. Patients with AST, ALT, γGT, TBIL or INR>1.5 ULN at Visit2. 3. Hospitalisation for asthma exacerb. within 3mths or intubation for asthma within 3yrs of Visit2. 4. Partially controlled (ACQ6>1.5) on iCS plus any other asthma controller at Visit2. 5. Respiratory tract infection or asthma exacerb. in the 4wks prior to Visit2 or during the run-in. In case of URTI (without asthma exacerb.) during run-in, patients can be pre-screened again 4wks after resolution. 6. Thoracotomy with pulmonary resection. Thoracotomy for other reasons should be assessed (excl.1). 7. Any safety net criteria are met during the run-in period a) In clinic FEV1 %predicted pre-bronchodilator <40%, b) >12 puffs rescue salbutamol HFA MDI per day for>2 consecutive days, c) Exacerbation of asthma. If AM2+ indicates a drop in absolute PEF of 30% from average absolute PEF of the last pre-screening week or last week prior to Visit4, for>2 consecutive days, an alert is generated, the patient should contact the study site for immediate assessment. 8. Previous participation in this study or participation in a current interventional study. 9. Significant alcohol or drug abuse within past 2yrs of Visit2. 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 2yrs. Effective methods of birth control include established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or IUS, barrier method of contraception: condom or occlusive cap with spermicidal foam/gel/film/ cream/suppository or male sterilization (with appropriate post-vasectomy document of the absence of sperm in the ejaculate). 12. Known hypersensitivity to any component of the investigat. treatment, salbutamol, fluticasone or montelukast components. 13. Patients who have been treated with any of the following medications in the given interval prior to Visit2: a) An investigational drug within 1mth or 6 1/2 lives (whichever is greater). b) Started on immunotherapy <1yr prior to Visit2. Patient should on the same course of immunotherapy for at least 1yr to be admitted into the study. Adjustment in dose within 1yr is allowed, as long as it involves the same course of immunotherapy and they have been on that dose for at least 6mths prior to Visit2. c)A biological based antagonist therapy including Omalizumab or immune modulator within 6mths. d)A systemic (i.v., i.m. or oral)corticosteroid within 3mths. e) A long acting anticholinergic bronchodilator within 2wks. f) Any of the following bronchodilators within 24hrs: inhaled anticholinergic agents, including fixed dose anticholinergic/ß2adrenergics, LABA including combination iCS/LABA, methylxanthines and oral β2agonists. g) Leukotriene modifiers, orally inhaled or oral nedocromil sodium/ sodium cromoglycate, mucolytics from morning of Visit2. h) The following anti-allergy medications within 2wks: topical nasal steroid (ocular steroids allowed) and cromolyn (nasal and oral cromones allowed),oral antihistamines, oral decongestants. Topical antihistamines and topical decongestants are permitted on an as needed basis for symptoms of allergic rhino-conjunctivitis. i) Non-steroidal anti-inflammatory medication including COX-2 inhibitors and aspirin (except ocular formulations) within 1wk. j) Non-cardio-selective β-blocker medications (e.g., propranolol) within 2wks. Topical β-blocker eye medications are allowed. 14) Patients taking specific CYP2C8 and CYP2C9 substrates and potent or moderate CYP3A4 inhibitors at Screening Visit2 or within 5 1/2 lives from Visit4, whichever is longer, will be excluded. A list of the specifically prohibited drugs is provided in the ISF at each site and updated as necessary by the sponsor. Any specific query should be directed to the sponsor prior to enrolment. 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 TdP (e.g. heart failure, hypokalemia, family, history of Long QT Syndrome, etc); c)Patients on concomitant medications known to prolong the QT/QTc interval.
    E.5 End points
    E.5.1Primary end point(s)
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Double - dummy
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Last patient out (last visit of the last subject entering 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 months5
    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 months5
    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) 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 state0
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 700
    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)
    Patients will go back on their usual medication (as per prior to entering the study).
    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 Decision2010-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-09
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