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    Summary
    EudraCT Number:2014-004775-23
    Sponsor's Protocol Code Number:MK-0476-383
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-08
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004775-23
    A.3Full title of the trial
    RADAR: SingulaiR® in Asthma anD Allergic Rhinitis An 8 week multicenter, open-label, observational study to evaluate the effectiveness of adding Montelukast Sodium (SINGULAIR®) 10 mg per day to inhaled corticosteroid or to inhaled corticosteroid/long-acting beta 2-agonist therapy in adult subjects with asthma and allergic rhinitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Singulair® for adult asthma and allergic rhinitis
    A.3.2Name or abbreviated title of the trial where available
    RADAR: SingulaiR® in Asthma anD Allergic Rhinitis
    A.4.1Sponsor's protocol code numberMK-0476-383
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00545844
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Frosst Canada Ltd.
    B.1.3.4CountryCanada
    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 supportMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number1 267 305 5921
    B.5.6E-mailgeorge_philip@merck.com
    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 Yes
    D.2.1.1.1Trade name SINGULAIR®
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Canada, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationCanada
    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 nameSINGULAIR®
    D.3.2Product code MK-0476
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 158966-92-8
    D.3.9.3Other descriptive nameMONTELUKAST SODIUM
    D.3.9.4EV Substance CodeSUB03324MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Adult asthma and allergic rhinitis
    E.1.1.1Medical condition in easily understood language
    Asthma and allergic rhinitis
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 describe the percentage of patients with asthma and allergic rhinitis
    who will achieve control of their asthma symptoms after 8 weeks of
    treatment with montelukast used either in combination with inhaled
    corticosteroid (ICS) or with inhaled corticosteroid/long-acting beta 2-
    agonist (ICS/LABA) therapy.
    E.2.2Secondary objectives of the trial
    To evaluate the effectiveness of montelukast therapy used in
    combination with ICS or ICS/LABA therapy in improving the
    symptoms of asthma.
    To describe the change in quality of life with respect to allergic
    rhinitis for patients using montelukast therapy in combination with
    ICS or ICS/LABA therapy.
    To describe patient and physician satisfaction with montelukast
    therapy with respect to their asthma when used in combination with
    ICS or ICS/LABA therapy.
    To describe patient global allergic rhinitis symptoms assessment.
    To describe the percentage of asthma patients, within the survey study
    sample, diagnosed with both asthma and allergic rhinitis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are 2> 15 years old (in the Province of Quebec, patients are 2: >18 years-old).
    Patient is diagnosed with asthma for at least 6 months.
    Patient has signed the Informed Consent before completing the survey.
    Patient is diagnosed with asthma for at least 6 months
    Patient is diagnosed with allergic rhinitis for at least one year.
    Patient's forced ,expiratory volume in one second (FEV1) or Peak expiratory flow is > 80% of predicted value on the day of visit 1.
    Patient is uncontrolled as per Canadian Asthma Consensus Guidelines.
    Patient is a user of ICS or ICS/LABA at any dosage. The dosage of ICS or ICS/LABA must have been stable for the past 30 days. A maximum of 4 patients on ICS/LABA per block of 8 will be allowed in the study.
    E.4Principal exclusion criteria
    Patient is well controlled with current controller therapy.
    Patient is already on montelukast sodium.
    Patient has rhinitis medicamentosa or non allergic rhinitis.
    Patient has evidence of significant nasal obstruction due to structural causes (e.g. markedly deviated nasal septum) that significantly interferes with nasal airflow as determined by the investigator.
    Patient is on a long-acting beta 2-agonist (LABA) alone, i.e. formoterol (Oxeze), salmeterol (Serevent).
    Patient is currently using an antibiotic for respiratory tract infection or has been treated with an antibiotic within 30 days of Visit 1 for respiratory tract infection (Initiation of antibiotic treatment will be allowed during the study).
    Patient has a history of Chronic Obstructive Pulmonary Disease (COPD).
    Patient has a history of cystic fibrosis, immune deficiency requiring specific therapy or any other diseases that could influence the evolution of asthma.
    Patient with hypersensitivity to any component of montelukast sodium 10 mg tablets.
    Patient has participated in an investigational drug trial in the last 30 days (prior to Visit 1).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percentage of patients whose asthma symptoms will be controlled after 8 weeks of montelukast treatment used in combination with ICS or ICS/LABA therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 8 weeks
    E.5.2Secondary end point(s)
    The proportion of patients that achieve control of asthma symptoms at 8-weeks as measured by the Asthma Control Questionnaire score (score ≤0.75 indicated controlled symptoms).
    The absolute and percent change in asthma symptom severity as measured with the Asthma Control Questionnaire score between baseline and 8 weeks. A decrease of ≥0.5 in ACQ score was considered clinically significant.
    The absolute and percent change in quality of life related to allergic rhinitis as measured with the overall Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) score condition between baseline and 8 weeks. An average change in overall score of ≥ 0.7 was considered clinically significant.
    The proportion of patients satisfied and the proportion of patients for whom the treating physicians were satisfied with treatment. Satisfaction with treatment was defined as a report of being “very satisfied” or “satisfied”, while dissatisfaction was defined as a report of being “very dissatisfied”, “dissatisfied” or “neither satisfied nor dissatisfied”.
    Description of patient global allergic rhinitis symptoms assessment.
    The proportion of patients diagnosed with both asthma and allergic rhinitis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline and 8 weeks
    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 No
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Montelukast added on to ICS or ICS/LABA therapy.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Canada
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    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.1.1Number of subjects for this age range: 13
    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.1.1.6.1Number of subjects for this age range: 13
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age with legal representative
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1350
    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)
    No
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Canada
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