[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100265938":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":51,"centralContacts":46,"locations":46,"responsibleParty":56,"collaborators":46,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":46,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":46,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":46,"overallStatus":78,"whyStopped":46,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":46},{"fullName":5,"class":6},"Organon and Co","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"MF\u002FF MDI 100\u002F10 mcg BID","EXPERIMENTAL","Eligible participants will be assigned randomly to receive double-blinded MF\u002FF MDI 100\u002F10 mcg BID for 24 weeks.",[13,14,15,16],"Drug: MF MDI 100 mcg BID (Open Label)","Drug: MF\u002FF MDI 100\u002F10 mcg BID","Drug: Albuterol\u002FSalbutamol PRN","Drug: Prednisone\u002FPrednisolone",{"label":18,"type":19,"description":20,"interventionNames":21},"MF MDI 100 mcg BID","ACTIVE_COMPARATOR","Eligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 weeks.",[13,22,15,16],"Drug: MF MDI 100 mcg BID",[24,32,38,42,47],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","MF MDI 100 mcg BID (Open Label)","Eligible participants will receive open-label MF MDI 100 mcg BID during a 2-week run-in period.",[18,9],[30,31],"ASMANEX HFA®","SCH 032088 (MK-0887)",{"type":25,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF\u002FF MDI 100\u002F10 mcg BID.",[9],[36,37],"DULERA®\u002FZENHALE®","SCH 418131 (MK-0887A)",{"type":25,"name":18,"description":39,"armGroupLabels":40,"otherNames":41},"After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF MDI 100 mcg BID.",[18],[30,31],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Albuterol\u002FSalbutamol PRN","Participants may use study-provided short-acting beta agonist (SABA), albuterol\u002Fsalbutamol, as needed (PRN) for the relief of asthma symptoms.",[18,9],null,{"type":25,"name":48,"description":49,"armGroupLabels":50,"otherNames":46},"Prednisone\u002FPrednisolone","Participants may use a systemic corticosteroid (prednisone\u002Fprednisolone) for acute asthma worsening per investigator discretion.",[18,9],[52],{"name":53,"affiliation":54,"role":55},"Medical Director","Merck Sharp & Dohme LLC","STUDY_DIRECTOR",{"type":57,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100265938","phase-3-study-of-efficacy-and-long-term-safety-of-mometasone-furoate-in-combination-with-formoterol-fumarate-versus-mometasone-furoate-in-children-5-to-11-years-of-age-with-persistent-asthma-mk-0887a-087-100265938",true,"NCT02741271","Study of Efficacy and Long-Term Safety of Mometasone Furoate in Combination With Formoterol Fumarate Versus Mometasone Furoate in Children (5 to 11 Years of Age) With Persistent Asthma (MK-0887A-087)","A Phase III, Randomized, Active-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Long-Term Safety of Mometasone Furoate\u002FFormoterol Fumarate (MF\u002FF, MK-0887A [SCH418131]), Compared With Mometasone Furoate (MF, MK-0887 [SCH032088]), in Children With Persistent Asthma","Inclusion Criteria:\n\n* Has a diagnosis of asthma of ≥ 6-months duration according to the Global Initiative for Asthma (GINA) guidelines\n* Has asthma that is adequately controlled on a stable dose of inhaled corticosteroid (ICS) combined with long-acting beta-agonist (LABA) ≥ 4 weeks\n* Is able to demonstrate an FEV1 \\>60% and ≤90% predicted\n* Is able to demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of albuterol\u002Fsalbutamol.\n* Is able to use an MDI (without spacer), use a peak flow meter, and perform spirometry correctly.\n* Is willing (with consent of their parent(s)\u002Fguardian) to discontinue previously prescribed asthma medication, if there is no inherent harm in changing the participant's current asthma therapy.\n* Has laboratory tests that are clinically acceptable to the investigator.\n\nExclusion Criteria:\n\n* Requires \\>8 inhalations per day of albuterol (100 mcg per actuation), and\u002For \\>2 nebulized treatments per day of 2.5 mg albuterol on any 2 consecutive days\n* Has a clinical worsening of asthma that results in emergency room visit (for an asthma exacerbation), hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) between the Screening and Baseline visits.\n* Is considered by the investigator to have unstable asthma at the end of the run-in period\n* Has had \\> 4 asthma exacerbations (defined as a worsening of asthma requiring systemic corticosteroid use and\u002For ≥ 24-hour stay in an emergency department, urgent care center, or hospital) within 1 year prior to visit 1\n* Has had a history of life-threatening asthma\n* Has a clinically significant condition or situation, other than the condition being studied which may interfere with trial evaluations, participant safety, or optimal participation in the trial",false,"ALL","5 Years","11 Years",{"count":70,"type":71},181,"ACTUAL","INTERVENTIONAL",[74],"PHASE3","This study compares the 12-week efficacy and 24-week safety of mometasone furoate\u002Fformoterol fumarate (MF\u002FF) 100\u002F10 mcg and mometasone furate (MF) 100 mcg, both administered twice daily (BID) via metered-dose inhaler (MDI) in children aged 5 to 11 years with persistent asthma.",[77],"Asthma","COMPLETED","2024-05-08",{"date":81,"type":71},"2024-05-16",{"date":83,"type":71},"2016-05-11",{"date":85,"type":71},"2017-12-04",{"name":5,"class":6}]