[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534093":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":29,"studyPopulation":21,"armGroups":30,"interventions":43,"overallOfficials":21,"centralContacts":56,"locations":65,"responsibleParty":82,"collaborators":21,"id":84,"slug":21,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":21,"enrollmentInfo":93,"targetDuration":21,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":21,"overallStatus":102,"whyStopped":21,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Eurofarma Laboratorios S.A.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Change to morning pre-dose FEV1","Change to morning pre-dose FEV1 at week 12 relative to baseline Forced expiratory volume in the first (FEV1).","week 12",[14,17],{"measure":15,"description":16,"timeFrame":12},"Change to SGRQ (Saint George's Respiratory Questionnaire)","Change to SGRQ (Saint George's Respiratory Questionnaire) total score at week 12 compared to baseline",{"measure":18,"description":19,"timeFrame":20},"Change to the COPD (chronic obstructive pulmonary disease )","Change to the COPD (chronic obstructive pulmonary disease ) Assessment Test (CAT - questionnaire to measure the impact of COPD on a person's life) in weeks 4 and 12 in relation to baseline","weeks 4 and 12",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":21,"timePerspective":21,"maskingInfo":27},"RANDOMIZED","PARALLEL","Experimental Group: Fluticasone Propionate 250 mcg\u002FFormoterol Fumarate dihydrate 12 mcg\u002FGlycopyrronium Bromide 25 mcg in the pharmaceutical form of hard capsule with powder for inhalation - 1 capsule per inhalation twice a day\n\nComparator Group: Beclomethasone Dipropionate 100 mcg\u002FFormoterol Fumarate dihydrate 6 mcg\u002FGlycopyrronium Bromide 12.5 mcg in pharmaceutical form aerosol solution in pressurized metered dose device (pMDI) for inhalation (Trimbow® - Chiesi Farmacêutica Ltda.) - 2 triggering twice a day","TREATMENT",{"masking":28,"maskingDescription":21,"whoMasked":21},"NONE","This is a phase 3 non-inferiority, randomized, open-label study with active control to compare the efficacy and safety of a fixed-dose triple combination to another triple combination with already established efficacy in subjects with symptomatic chronic obstructive pulmonary disease (COPD).\n\nThis study will be conducted in two stages. Study Step 1 The primary assessment of non-inferiority will be performed after 12 weeks of treatment by assessing FEV1 (Forced expiratory volume in the first second) in relation to baseline.\n\nStudy Step 2 In a second step, it will be assessed whether the benefits of the new triple combination on respiratory symptoms and health-related quality of life are sustained in the long term and to determine the annual rate of flares in 52 weeks of treatment.\n\nThe study will comprise a screening phase, consisting of a screening and run-in visit lasting up to 14 days, and a treatment phase in which, after collecting baseline data (which includes assessment of FEV1 (Forced expiratory volume in the first second) and quality of life through a questionnaire), participants will be randomized and begin their respective treatments.\n\nVisits during Step 1 of treatment will be performed at weeks 4 and 12. The week 12 visit will be the primary endpoint visit.\n\nAfter 12 weeks, Step 2 of the study will begin with all participants who completed Step 1 and who agreed to remain in the study to receive Eurofarma's experimental drug for up to 52 weeks. Visits during this step will be performed at weeks 24, 36 and 52 to assess safety, quality of life, lung function and flare rate (exploratory endpoints).",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Fluticasone Propionate 250 mcg\u002FFormoterol Fumarate dihydrate 12 mcg\u002FGlycopyrronium Bromide 25 mcg","EXPERIMENTAL","Fluticasone Propionate 250 mcg\u002FFormoterol Fumarate dihydrate 12 mcg\u002FGlycopyrronium Bromide 25 mcg in the pharmaceutical form of hard capsule with powder for inhalation - 1 capsule per inhalation twice a day",[36],"Drug: Fluticasone 250mcg\u002FFormoterol 12mcg\u002FGlycopyrronium 25mcg",{"label":38,"type":39,"description":40,"interventionNames":41},"Trimbow® (Beclomethasone 100 mcg\u002FFormoterol 6 mcg\u002FGlycopyrronium 12.5 mcg)","ACTIVE_COMPARATOR","Beclomethasone Dipropionate 100 mcg\u002FFormoterol Fumarate dihydrate 6 mcg\u002FGlycopyrronium Bromide 12.5 mcg in pharmaceutical form aerosol solution in pressurized metered dose device (pMDI) for inhalation (Trimbow® - Chiesi Farmacêutica Ltda.) - 2 triggering twice a day",[42],"Drug: Comparator - Trimbow®",[44,50],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","Fluticasone 250mcg\u002FFormoterol 12mcg\u002FGlycopyrronium 25mcg","Participants randomized to this group will receive 1 capsule per inhalation twice a day",[32],[32],{"type":45,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Comparator - Trimbow®","Participants randomized to this group will receive 2 triggering twice a day",[38],[55],"Trimbow® - Beclomethasone Dipropionate 100 mcg\u002FFormoterol Fumarate dihydrate 6 mcg\u002FGlycopyrronium Bromide 12.5 mcg",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":21,"email":61},"Edilene Macedo","CONTACT","+551150908600","edilene.macedo@eurofarma.com",{"name":63,"role":59,"phone":60,"phoneExt":21,"email":64},"Gleyce Pinto","gleyce.lima@eurofarma.com",[66],{"facility":67,"status":21,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Eurofarma Laboratorios S.A","São Paulo","Padrão","06696-000","Brazil","BR",{"type":74,"coordinates":75},"Point",[76,77],-46.63611,-23.5475,{"lat":77,"lon":76},[80,81],{"name":58,"role":59,"phone":60,"phoneExt":21,"email":61},{"name":63,"role":59,"phone":60,"phoneExt":21,"email":64},{"type":83,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100534093",false,"NCT06234345","Study of Fluticasone\u002FFormoterol\u002FGlycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)","Randomized, Open-label, Parallel, Active-controlled, Multicenter Study of Efficacy and Safety of Fixed-dose Combination of Fluticasone \u002FFormoterol \u002FGlycopyrronium for the Treatment of Patients with Chronic Obstructive Pulmonary Disease","TRIPLAR","Inclusion Criteria:\n\n* Participants of both sexes who meet all of the following criteria will be included in the study:\n\n  1. Signed Informed Consent Form (ICF).\n  2. Male or female aged 40 or over.\n  3. Medical diagnosis of chronic obstructive pulmonary disease (COPD) documented by post-bronchodilator FEV1\u002FFVC (Forced Expiratory Volume in the 1st second\u002F Forced Vital Capacity) ratio \\\u003C 0.7 (Previous examination report or examination performed at the screening visit).\n\nExclusion Criteria:\n\n* Participants who meet any of the following criteria will be excluded from the study:\n\n  1. Pregnant or lactating women.\n  2. Current diagnosis of asthma without current diagnosis of chronic obstructive pulmonary disease (COPD). Observation: Subjects with a prior history of asthma are eligible if they have a current diagnosis of chronic obstructive pulmonary disease (COPD).\n  3. Other respiratory disorders other than chronic obstructive pulmonary disease (COPD) (for example, but not restricted to: active tuberculosis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension).","ALL","40 Years",{"count":94,"type":95},1252,"ESTIMATED","INTERVENTIONAL",[98],"PHASE3","Several studies have demonstrated the benefits of the LAMA (Long-Acting Muscarinic Antagonists) + LABA (Long-Acting Beta-Agonists) + IC (inhaled corticosteroids) combination in the treatment of chronic obstructive pulmonary disease (COPD). The use of the triple combination in patients with severe airflow obstruction and a history of flares has been associated with improved lung function, improved patient-reported endpoints and prevention of flares, when compared to LABA, LABA + LAMA and LABA + IC. Furthermore, when compared to dual therapies LABA + IC and LABA + LAMA, triple therapy has been able to reduce all-cause deaths among chronic obstructive pulmonary disease (COPD) patients.\n\nPreviously published studies have demonstrated that the triple combination of Fluticasone 250 mcg\u002FFormoterol 12 mcg\u002FGlycopyrronium 12.5 mcg was able to improve lung function in chronic obstructive pulmonary disease (COPD) patients with a history of flares. There was also a significant improvement in the mMRC (modified-Medical Research Council) which began in the 2nd week of treatment and continued up to week 12. The association was considered safe and well tolerated, with only mild to moderate adverse events recorded in approximately 25% of the subjects treated in the study.\n\nFurthermore, bioavailability studies performed with the components of the combination proposed as experimental drug - Fluticasone\u002FFormoterol\u002FGlycopyrronium - indicated that there is no pharmacokinetic interaction between the 3 active ingredients when they were administered concomitantly to healthy individuals under fasting conditions.",[101],"Chronic Obstructive Pulmonary Disease","NOT_YET_RECRUITING","2025-02-13",{"date":105,"type":106},"2025-02-14","ACTUAL",{"date":108,"type":95},"2026-09",{"date":110,"type":95},"2028-08",{"name":5,"class":6},1]