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    Summary
    EudraCT Number:2014-004926-17
    Sponsor's Protocol Code Number:P04879
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-16
    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 number2014-004926-17
    A.3Full title of the trial
    OPEN LABEL, 12-WEEK CLINICAL TRIAL TO ASSESS EFFICACY, SAFETY, TREATMENT ADHERENCE AND QUALITY OF LIFE IMPACT ON MOMETASONE FUROATE DRY POWDER 400 MCG ONCE DAILY IN PERSISTENT MILD-MODERATE ASTHMATIC PATIENTS AT LEAST 12 YEARS OLD (APEGO STUDY)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate in Asthmatic Patients
    A.3.2Name or abbreviated title of the trial where available
    Clinical Trial to Assess Efficacy,Safety,Treatment Adherence&QOL Impact of MF in Asthmatic Patients
    A.4.1Sponsor's protocol code numberP04879
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00687531
    A.5.4Other Identifiers
    Name:-Number:MK-0887-125
    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 SponsorSchering-Plough S.A.de C.V.
    B.1.3.4CountryMexico
    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 supportSchering-Plough S.A.de C.V.
    B.4.2CountryMexico
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSchering-Plough S.A.de C.V.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressAv. 16 De Septiembre No. 301, Mexico City,
    B.5.3.2Town/ cityCol. Xaltocan, Deleg. Xochimilco, Distrito Federal
    B.5.3.3Post code16090
    B.5.3.4CountryMexico
    B.5.4Telephone number+12673055921
    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 ELOVENT® TWISTHALER®
    D.2.1.1.2Name of the Marketing Authorisation holderSCHERING-PLOUGH, S.A. DE C.V.
    D.2.1.2Country which granted the Marketing AuthorisationMexico
    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 nameELOVENT® TWISTHALER®
    D.3.2Product code SCH 32088 (MK-0887)
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    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.3.9.2Current sponsor codeMK-0887 and SCH 32088
    D.3.9.3Other descriptive nameMOMETASONE FUROATE
    D.3.9.4EV Substance CodeSUB03318MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Persistent asthma
    E.1.1.1Medical condition in easily understood language
    Persistent asthma
    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
    The primary objective is to assess mean change in FEV1 from baseline to the endpoint of study.
    E.2.2Secondary objectives of the trial
    1. Changes from baseline in the subject's twice-daily assessment (AM & PM) symptoms
    2. Changes from Baseline in AM and OM Peak Expiratory Flow Rate(PEFR)
    3. Changes in Score of Asthma Quality of Life Questionnaire from baseline to the endpoint and general Quality of Life Questionnaires
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects must have a diagnosed history of mild moderate persistent asthma for the last 12 months
    • The Subject's FEV1 must be >=60% of predicted normal or personal best FEV1 during the last 12 months
    • Subjects must have been using daily inhaled corticosteroids for at least 30 days prior to screening. In the screening visit patients FEV1 should be >/= 65% to </= 90% predicted
    • Asthma symptom total daily (AM +PM) severity score at the screening should be </= 2
    • For the two weeks prior to screening, subjects must have been on a stable regimen of one of the following twice daily regimen: FP >=100 -<= 500 mcg/day, BUD >= 200 - <= 1000 mcg/day, BDP >= 200 - <= 1000 mcg/day, TA >= 400 - < =2000 mcg/day
    • During the ICS Dose Reduction period of sequential ICS dose reduction, subjects must demonstrate a measurable loss of asthma control, with both A) Decreased Lung Function (either FEV1 or PEFR) and B) Increased Symptoms.
    E.4Principal exclusion criteria
    • Female subjects who are pregnant or breast-feeding.
    • Subjects who have not observed the designated washout periods for any of the prohibited medications outlined
    • Subjects who have used any investigational product within 30 days or any antibodies for asthma or allergic rhinitis in the past 90 days prior to enrollment.
    • Subjects who have any clinically significant deviation from normal in the physical examination that, in the Investigator’s judgment, may interfere with the study evaluations or affect subject safety.
    • Subjects who have required systemic steroids within the previous month.
    • Subjects who are allergic or have an idiosyncratic reaction to corticosteroids.
    • Subjects who have required inpatient hospitalization for asthma control within the previous 3 months, or more than once in the previous 6 months.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the trial was mean change from Baseline in the FEV1 (percentage change from baseline).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The FEV1 measurements were done in Visit 1, Visit 2 and Visit 5.
    E.5.2Secondary end point(s)
    The secondary endpoints for the trial were: PEFR, asthma symptoms and the measure of Health Quality of Life.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The PEFR variable was measured throughout the whole study visits (day 1, week 4[visit 3], week 8 [visit 4] and week 12 [visit 5]).
    The Asthma quality of life and general quality of life questionnaires were conducted in Baseline (visit 2) protocol visit and endpoint protocol visit (visit 5).
    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 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 No
    E.8.1.1Randomised No
    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 No
    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
    Mexico
    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 months4
    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.1.2.1Number of subjects for this age range: 216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 360
    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)
    Future care provided to subject by personal physician
    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: Mexico
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