[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100103106":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":32,"locations":38,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":32,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":32,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":95,"whyStopped":32,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"indacaterol maleate\u002Fmometasone furoate","EXPERIMENTAL","Participants received 2 inhalations of indacaterol maleate \u002F mometasone furoate 250\u002F400 μg once daily in the evening (full dose 500\u002F800 μg) delivered via the Twisthaler device for 14 days.",[13],"Drug: indacaterol maleate \u002F mometasone furoate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants received 2 inhalations of placebo to indacaterol maleate \u002F mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.",[19],"Drug: placebo to indacaterol maleate\u002Fmometasone furoate",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","indacaterol maleate \u002F mometasone furoate","Indacaterol maleate \u002F mometasone furoate 250\u002F400 μg, 2 puffs once daily delivered via the Twisthaler device.",[9],[27],"QMF149",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"placebo to indacaterol maleate\u002Fmometasone furoate","Placebo to indacaterol maleate\u002Fmometasone furoate delivered via the Twisthaler device.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"NOVARTIS","Novartis investigator site","PRINCIPAL_INVESTIGATOR",[39,50,57],{"facility":40,"status":32,"city":41,"state":32,"zip":32,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":32},"Novartis Investigator Site","Neuil","France","FR",{"type":45,"coordinates":46},"Point",[47,48],0.51155,47.17219,{"lat":48,"lon":47},{"facility":40,"status":32,"city":51,"state":32,"zip":32,"country":42,"countryCode":43,"cosmosGeoPoint":52,"geoPoint":56,"contacts":32},"Paris",{"type":45,"coordinates":53},[54,55],2.3488,48.85341,{"lat":55,"lon":54},{"facility":40,"status":32,"city":58,"state":32,"zip":32,"country":42,"countryCode":43,"cosmosGeoPoint":59,"geoPoint":63,"contacts":32},"Poitiers",{"type":45,"coordinates":60},[61,62],0.34348,46.58261,{"lat":62,"lon":61},{"type":65,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[67],{"name":68,"class":6},"Merck Sharp & Dohme LLC","100103106","phase-2-safety-and-tolerability-of-indacaterol-maleatemometasone-furoate-delivered-via-the-twisthaler-device-after-14-days-treatment-in-patients-with-mild-to-moderate-asthma-100103106",true,"NCT00605306","Safety and Tolerability of Indacaterol Maleate\u002FMometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma","A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Tolerability of 14-days Treatment With an Inhaled Dose of QMF149 (500\u002F800) in Mild to Moderate Asthmatic Patients","Inclusion Criteria:\n\n* Male and female adult patients aged 18-65 years (inclusive)\n* Patients with mild-moderate asthma\n* Forced expiratory volume in one second (FEV1) at Visits 1 and 2 are ≥60% of the predicted normal value for the patient.\n* Body mass index (BMI) must be within the range of 18-32 kg\u002Fm\\^2.\n* Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less.\n\nExclusion Criteria:\n\n* Patients who suffer from chronic obstructive pulmonary disease (COPD)\n* Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start\n* QTcF interval \\> 450 msec in men and \\>470 msec in women\n* Pregnant women or nursing mothers\n* Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).\n* History of immunocompromise, including a positive human immunodeficiency virus (HIV)\n* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.\n* History of drug or alcohol abuse within 12 months of dosing\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",false,"ALL","18 Years","65 Years",{"count":81,"type":82},28,"ACTUAL","INTERVENTIONAL",[85],"PHASE2","This study will investigate the safety and tolerability of indacaterol maleate\u002Fmometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.",[88],"Asthma",[88,90,91,92,93,94],"spirometry","lung function","serum cortisol","serum potassium","plasma glucose","COMPLETED","2013-03-11",{"date":98,"type":99},"2013-04-22","ESTIMATED",{"date":101,"type":32},"2008-01",{"date":103,"type":82},"2008-04",{"name":5,"class":6},3]