[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498951":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":45,"studyPopulation":31,"armGroups":46,"interventions":60,"overallOfficials":78,"centralContacts":82,"locations":88,"responsibleParty":261,"collaborators":31,"id":263,"slug":264,"hasResults":265,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":31,"eligibilityCriteria":269,"healthyVolunteers":265,"sex":270,"minAge":271,"maxAge":272,"enrollmentInfo":273,"targetDuration":31,"studyType":276,"phases":277,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":91,"whyStopped":31,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in Trough FEV1","FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.","Baseline, Week 12 of each treatment period.",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Change from Baseline in Asthma Control Questionnaire (ACQ-5) score","The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and\u002For severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment\u002Flimitation) to six (total impairment\u002F limitation) scale. ACQ-5 score range from 0 to 6. Higher scores indicates worsening of condition.","Baseline, Week 12 of each treatment period",{"measure":19,"description":20,"timeFrame":17},"Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) total score","Pediatric Asthma Quality of Life Questionnaire is a 23-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with 7-point scale (7-not bothered at all, 1-extremely bothered). It consists of 3 domains: symptoms, activity limitation and emotional function. Higher scores indicate less impairment in HRQOL.\n\nThe overall PAQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains.",{"measure":22,"description":23,"timeFrame":17},"Change from Baseline in average Rescue medication use (daily, daytime, and nighttime)","Rescue medication use over 12 weeks of each treatment period.",{"measure":25,"description":26,"timeFrame":17},"Number and severity of reported asthma exacerbations","Asthma exacerbations over 12 weeks of each treatment period",{"measure":28,"description":29,"timeFrame":30},"Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)","Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.","From first dose up to 30 days after last dose (up to 31 weeks)",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":35,"primaryPurpose":36,"observationalModel":31,"timePerspective":31,"maskingInfo":37},"RANDOMIZED","CROSSOVER","A double-dummy, double-blind, randomized, active controlled study.","TREATMENT",{"masking":38,"maskingDescription":39,"whoMasked":40},"QUADRUPLE","All site staff, including pharmacist will be blinded. All sponsor staff will be blinded.",[41,42,43,44],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a double-dummy, double-blind, randomized, active controlled, two-way two-period treatment (12 weeks duration each) cross-over study.\n\nThe study duration of 36 weeks includes:\n\n* a screening period of up to 15 days (rescue medication: short acting β2-agonist (SABA) salbutamol 100 μg or albuterol 90 μg via a Metered-Dose Inhaler (MDI) to use as-needed throughout the study).\n* a run-in period of 14 days (run-in medication: salmeterol xinafoate 50 μg \u002F fluticasone propionate 250μg bid delivered via Girohaler® or equivalent DPI device)\n* two treatment period of 12 weeks each (either QVM149 150\u002F50\u002F160 µg od and placebo to salmeterol xinafoate\u002Ffluticasone propionate 50\u002F500 µg bid, or salmeterol xinafoate\u002Ffluticasone propionate 50\u002F500 µg bid and placebo to QVM149 150\u002F50\u002F160 µg od, separated by a 3 week washout period (wash-out medication: salmeterol xinafoate\u002Ffluticasone propionate 50\u002F250 µg bid)\n* a safety follow up period of 30 days during which the participant will be back on standard of care treatment as appropriate.",[47,56],{"label":48,"type":49,"description":50,"interventionNames":51},"Arm 1: QVM149 first, then salmeterol xinafoate\u002Ffluticasone propionate","EXPERIMENTAL","* QVM149 150\u002F50\u002F160 µg od and placebo to salmeterol xinafoate\u002Ffluticasone propionate 50\u002F500 μg bid during treatment period 1.\n* Then, after a 3-week washout period, salmeterol xinafoate\u002Ffluticasone propionate 50\u002F500 μg bid and placebo to QVM149 150\u002F50\u002F160 µg od during treatment period 2.",[52,53,54,55],"Drug: QVM149","Drug: Salmeterol Xinafoate \u002F Fluticasone Propionate","Drug: Placebo to QVM149","Drug: Placebo to salmeterol xinafoate \u002F fluticasone propionate",{"label":57,"type":49,"description":58,"interventionNames":59},"Arm 2: Salmeterol xinafoate\u002Ffluticasone propionate first, then QVM149","* Salmeterol xinafoate\u002Ffluticasone propionate 50\u002F500 μg bid and placebo to QVM149 150\u002F50\u002F160 µg od during treatment period 1.\n* Then, after a 3-week washout period, QVM149 150\u002F50\u002F160 µg od and placebo to salmeterol xinafoate\u002Ffluticasone propionate 50\u002F500 μg bid during treatment period 2.",[52,53,54,55],[61,66,70,74],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":31},"DRUG","QVM149","QVM149: Indacaterol as acetate 150 µg \u002F glycopyrronium as bromide 50 µg \u002F mometasone furoate 160 µg once daily delivered via Breezhaler®",[48,57],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":31},"Salmeterol Xinafoate \u002F Fluticasone Propionate","Salmeterol xinafoate 50 μg \u002F fluticasone propionate 500 μg twice daily delivered via Girohaler®",[48,57],{"type":62,"name":71,"description":72,"armGroupLabels":73,"otherNames":31},"Placebo to QVM149","Placebo to QVM149 150\u002F50\u002F160 µg once daily delivered via Breezhaler®",[48,57],{"type":62,"name":75,"description":76,"armGroupLabels":77,"otherNames":31},"Placebo to salmeterol xinafoate \u002F fluticasone propionate","Placebo to salmeterol xinafoate\u002Ffluticasone propionate 50\u002F500 μg twice daily delivered via Girohaler®",[48,57],[79],{"name":80,"affiliation":80,"role":81},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[83,87],{"name":80,"role":84,"phone":85,"phoneExt":31,"email":86},"CONTACT","+41613241111","novartis.email@novartis.com",{"name":80,"role":84,"phone":31,"phoneExt":31,"email":31},[89,102,112,122,130,138,146,154,162,172,183,194,203,211,219,228,234,243,251],{"facility":90,"status":91,"city":92,"state":31,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":31},"Novartis Investigative Site","RECRUITING","Strasbourg","67091","France","FR",{"type":97,"coordinates":98},"Point",[99,100],7.74553,48.58392,{"lat":100,"lon":99},{"facility":90,"status":91,"city":103,"state":31,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":31},"Szeged","6720","Hungary","HU",{"type":97,"coordinates":108},[109,110],20.14824,46.253,{"lat":110,"lon":109},{"facility":90,"status":91,"city":113,"state":114,"zip":115,"country":114,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":121,"contacts":31},"Tarnów","Poland","33-100","PL",{"type":97,"coordinates":118},[119,120],20.98698,50.01381,{"lat":120,"lon":119},{"facility":90,"status":91,"city":123,"state":31,"zip":124,"country":114,"countryCode":116,"cosmosGeoPoint":125,"geoPoint":129,"contacts":31},"Bialystok","15-698",{"type":97,"coordinates":126},[127,128],23.16433,53.13333,{"lat":128,"lon":127},{"facility":90,"status":91,"city":131,"state":31,"zip":132,"country":114,"countryCode":116,"cosmosGeoPoint":133,"geoPoint":137,"contacts":31},"Krakow","31-625",{"type":97,"coordinates":134},[135,136],19.93658,50.06143,{"lat":136,"lon":135},{"facility":90,"status":91,"city":139,"state":31,"zip":140,"country":114,"countryCode":116,"cosmosGeoPoint":141,"geoPoint":145,"contacts":31},"Lublin","20-637",{"type":97,"coordinates":142},[143,144],22.57009,51.25058,{"lat":144,"lon":143},{"facility":90,"status":91,"city":147,"state":31,"zip":148,"country":114,"countryCode":116,"cosmosGeoPoint":149,"geoPoint":153,"contacts":31},"Piaseczno","05-500",{"type":97,"coordinates":150},[151,152],21.02397,52.0814,{"lat":152,"lon":151},{"facility":90,"status":91,"city":155,"state":31,"zip":156,"country":114,"countryCode":116,"cosmosGeoPoint":157,"geoPoint":161,"contacts":31},"Torun","87-100",{"type":97,"coordinates":158},[159,160],18.59814,53.01375,{"lat":160,"lon":159},{"facility":90,"status":91,"city":163,"state":31,"zip":164,"country":165,"countryCode":166,"cosmosGeoPoint":167,"geoPoint":171,"contacts":31},"Bucharest","050159","Romania","RO",{"type":97,"coordinates":168},[169,170],26.10626,44.43225,{"lat":170,"lon":169},{"facility":90,"status":91,"city":173,"state":174,"zip":175,"country":176,"countryCode":177,"cosmosGeoPoint":178,"geoPoint":182,"contacts":31},"Bratislava","Mestska Cast Ruzinov","821 08","Slovakia","SK",{"type":97,"coordinates":179},[180,181],17.10674,48.14816,{"lat":181,"lon":180},{"facility":90,"status":91,"city":184,"state":185,"zip":186,"country":187,"countryCode":188,"cosmosGeoPoint":189,"geoPoint":193,"contacts":31},"East London","Eastern Cape","5201","South Africa","ZA",{"type":97,"coordinates":190},[191,192],27.91162,-33.01529,{"lat":192,"lon":191},{"facility":90,"status":91,"city":195,"state":196,"zip":197,"country":187,"countryCode":188,"cosmosGeoPoint":198,"geoPoint":202,"contacts":31},"Germiston","Gauteng","1401",{"type":97,"coordinates":199},[200,201],28.17665,-26.23481,{"lat":201,"lon":200},{"facility":90,"status":91,"city":204,"state":196,"zip":205,"country":187,"countryCode":188,"cosmosGeoPoint":206,"geoPoint":210,"contacts":31},"Krugersdorp","1739",{"type":97,"coordinates":207},[208,209],27.77515,-26.08577,{"lat":209,"lon":208},{"facility":90,"status":91,"city":212,"state":196,"zip":213,"country":187,"countryCode":188,"cosmosGeoPoint":214,"geoPoint":218,"contacts":31},"Lenasia","1827",{"type":97,"coordinates":215},[216,217],27.83564,-26.32052,{"lat":217,"lon":216},{"facility":90,"status":91,"city":220,"state":221,"zip":222,"country":187,"countryCode":188,"cosmosGeoPoint":223,"geoPoint":227,"contacts":31},"Paarl","Western Cape","7626",{"type":97,"coordinates":224},[225,226],18.97523,-33.73378,{"lat":226,"lon":225},{"facility":90,"status":91,"city":229,"state":230,"zip":231,"country":232,"countryCode":233,"cosmosGeoPoint":31,"geoPoint":31,"contacts":31},"Santiago Compostela","A Coruna","15706","Spain","ES",{"facility":90,"status":91,"city":235,"state":236,"zip":237,"country":232,"countryCode":233,"cosmosGeoPoint":238,"geoPoint":242,"contacts":31},"Sabadell","Barcelona","08208",{"type":97,"coordinates":239},[240,241],2.10942,41.54329,{"lat":241,"lon":240},{"facility":90,"status":91,"city":244,"state":31,"zip":245,"country":232,"countryCode":233,"cosmosGeoPoint":246,"geoPoint":250,"contacts":31},"Seville","41013",{"type":97,"coordinates":247},[248,249],-5.97317,37.38283,{"lat":249,"lon":248},{"facility":90,"status":91,"city":252,"state":31,"zip":253,"country":254,"countryCode":255,"cosmosGeoPoint":256,"geoPoint":260,"contacts":31},"Kaohsiung City","833","Taiwan","TW",{"type":97,"coordinates":257},[258,259],120.31333,22.61626,{"lat":259,"lon":258},{"type":262,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100498951","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-qvm149-indacaterol-acetate--glycopyrronium-bromide--mometasone-furoate-versus-salmeterol-xinafoatefluticasone-propionate-in-children-from-12-years-to-less-than-18-years-of-age-with-asthma-100498951",false,"NCT05776927","A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate \u002F Glycopyrronium Bromide \u002F Mometasone Furoate) Versus Salmeterol Xinafoate\u002FFluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.","A Double-dummy, Double-blind, Randomized, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration Period, to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate \u002F Glycopyrronium Bromide \u002F Mometasone Furoate) Compared to Salmeterol Xinafoate\u002FFluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.","Key Inclusion criteria:\n\n* Male and female adolescent participants aged from ≥ 12 years old to less than 18 years old at screening visit\n* Participants with a documented diagnosis of persistent asthma (according to Global Initiative for Asthma GINA 2024) for a period of at least 1 year prior to screening.\n* Participants who have used medium or high dose ICS with LABA in combination (GINA 2024) for asthma for at least 3 months and at stable doses for at least 1 month prior to screening\n* Participants must be symptomatic \u002F inadequately controlled according to the Investigator's opinion despite treatment with medium or high stable doses of ICS with LABA in combination (GINA 2024) before screening\n* Participants who demonstrate an increase in FEV1 of ≥ 12% within 15 to 30 minutes after administration of 200-400 μg salbutamol\u002F180-360 μg albuterol at run-in visit\n* Pre-bronchodilator FEV1 ≥ 50% of the predicted normal value for the participant according to American Thoracic Society\u002FEuropean Respiratory Society (ATS\u002FERS) 2019 criteria at both run-in and before randomization\n\nKey Exclusion criteria:\n\n* Participants who have had a severe asthma attack\u002Fexacerbation requiring systemic steroids OR hospitalization (\\> 24 hours) OR emergency room (ER) visit (≤ 24 hours) within 6 weeks of screening. If participants experience an asthma attack\u002Fexacerbation requiring systemic steroids or emergency room visit between screening and end of run-in they may be re-screened 6 weeks after recovery from the exacerbation\n* Participants who have ever required intubation for a severe asthma attack\u002Fexacerbation\n* Participants with a history of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis\n* Participants with Type I diabetes or uncontrolled Type II diabetes\n* Participants who have a clinically significant laboratory abnormality as per investigator judgement before the end of run-in\n* Participants with a history of myocardial infarction (this should be confirmed clinically by the Investigator) within the previous 12 months\n* Participants with a history of long QT syndrome or a family history of a first degree relative with sudden cardiac death under the age of 50 years, or participants whose QTc measured at run-in or at baseline (prior to randomization) (Fridericia method) is prolonged (\\> 450 msec for males and \\> 460 msec for females) and confirmed by a central assessor or the inability to determine the QT interval corrected by Fridericia's formula (QTcF) interval (these participants should not be re-screened)\n* Female participants of childbearing potential defined as all females physiologically capable of becoming pregnant (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria\n* Use of long-acting muscarinic antagonist (LAMA) within 3 months prior to screening\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","12 Years","17 Years",{"count":274,"type":275},188,"ESTIMATED","INTERVENTIONAL",[278],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate \u002F glycopyrronium bromide \u002F mometasone furoate (QVM149) compared to salmeterol xinafoate \u002F fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.",[281],"Asthma",[281,283,63,284,285,286,287,288],"Adolescent","Pediatric","LABA","LAMA","ICS","Triple Combination","2026-09-10",{"date":291,"type":292},"2026-09-11","ACTUAL",{"date":294,"type":292},"2026-08-04",{"date":296,"type":275},"2029-01-30",{"name":80,"class":6},19]