[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559733":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":54,"studyPopulation":55,"armGroups":50,"interventions":56,"overallOfficials":50,"centralContacts":63,"locations":73,"responsibleParty":93,"collaborators":95,"id":98,"slug":50,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":50,"maxAge":50,"enrollmentInfo":106,"targetDuration":50,"studyType":109,"phases":50,"briefSummary":110,"conditions":111,"keywords":50,"overallStatus":76,"whyStopped":50,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Chiesi Poland Sp. z o.o.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice.","Primary outcome measures include:\n\nDescriptive analisys of patients demografic\n\nDescriptive analisys of patient demographic","12 months",[14,17,20,23,26,29,32,35,38,41,44,47],{"measure":15,"description":16,"timeFrame":12},"Assess asthma control (ACT)","\\- Assess asthma control (ACT) - Change from baseline in ACT scores",{"measure":18,"description":19,"timeFrame":12},"Assess quality of life To measure the functional impairments","\\- Assess quality of life - Change from baseline in Mini-AQLQ scores",{"measure":21,"description":22,"timeFrame":12},"Treatment adherence","\\- Assess treatment adherence - Change from baseline in TAI scores",{"measure":24,"description":25,"timeFrame":12},"Lung function","\\- Analyse parameters of lung function using spirometry - Change from baseline in FEV1",{"measure":27,"description":28,"timeFrame":12},"Small airways parameters","\\- Analyse parameters of small airways disease - Change from baseline in small airway function measured by pre-dose AUCAX (Area under the curve of reactance) using available oscillometry system",{"measure":30,"description":31,"timeFrame":12},"Airway inflammation","\\- Analyse parameters of asthma-related airway inflammation - Change from baseline in percentage of patients with a fraction of exhaled nitric oxide (FeNO) below or above 20 ppb",{"measure":33,"description":34,"timeFrame":12},"Persistent airflow limitation","\\- Analyse parameters of persistent airflow limitation - Change from baseline in percentage of patients with persistent airflow limitation (PAL); PAL defined as post-BD FEV1 \\\u003C80% predicted and post-BD FEV1\u002FFVC Ratio \\\u003C 0.7",{"measure":36,"description":37,"timeFrame":12},"Asthma exacerbations","\\- Analyse the incidence of asthma exacerbations - Number of exacerbations 12 months prior to baseline and during study",{"measure":39,"description":40,"timeFrame":12},"Rescue medication use","\\- Analyse use of rescue medication - Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit",{"measure":42,"description":43,"timeFrame":12},"Systemic corticosteroids use","\\- Analyse use of systemic corticosteroids - Use of any systemic corticosteroids 12 months prior to baseline and during study",{"measure":45,"description":46,"timeFrame":12},"Adverse events occurence","\\- Assess adverse events associated with use of Trimbow - Assessment of the number and type of adverse events",{"measure":48,"description":49,"timeFrame":12},"Retention rate with Trimbow","\\- Assess retention rate with Trimbow - Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12",null,{"allocation":50,"interventionModel":50,"interventionModelDescription":50,"primaryPurpose":50,"observationalModel":52,"timePerspective":53,"maskingInfo":50},"COHORT","PROSPECTIVE","The goals of asthma therapy for all degrees of disease severity are minimising asthma symptoms, maximising lung function, and preventing asthma exacer-bations. Despite the existing treatment options and differentiated guidelines, 35 % to 45 % of the GINA 4\u002F5 patients suffer from inadequately controlled symptoms. To investigate the cause of unsatisfactory treatment results, it is essential to monitor therapy pathways of asthma patients in a real-world set-ting. Resulting data can be compared to therapy guidelines and generate hy-potheses for future clinical trials.\n\nTrimbow® is a fixed triple therapy containing a long-acting muscarinic antago-nist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclomethasone). Trimbow® MS (medium strength) contains 100 µg beclomethasone whereas Trimbow® HS (high strength) contains 200 µg beclomethasone. Both formulations are investigated in this study.\n\nTrimbow® has shown major clinical benefits in randomised controlled trials. However, the effects of Trimbow® on changes in patients' symptom burden and quality of life, adherence and clinical outcomes have not been yet as-sessed in a real-world asthma patient population.\n\nThe primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow® in real world practice.\n\nSecondary objectives include:\n\n* To assess asthma control (ACT)\n* To assess quality of life (Mini-AQLQ)\n* To assess treatment adherence (TAI)\n* To analyse parameters of lung function\n* To analyse parameters of small airways disease (FEF 25-75, RV\u002FTLC)\n* To analyse parameters of asthma-related airway inflammation (FeNO)\n* To analyse parameters of persistent airways limitation (reversibility testing FEV1\u002FFVC)\n* To analyse the incidence and the severity of asthma exacerbations\n* To analyse the use of rescue medication\n* To analyse the use of systemic corticosteroids\n* To assess healthcare resource utilisation\n* To assess treatment satisfaction with Trimbow®\n* To assess tolerability of Trimbow® This is a non-interventional, longitudinal, international, multicentre study with prospective data collection. At baseline, the patient's medical history with spe-cial focus on asthma will be collected. The study baseline visit is at the time point of start of treatment with Trimbow®. Trimbow® treatment may have started up to a maximum of 4 weeks prior to inclusion of the patient into this NIS.\n\nThe planned observational period per patient should be at least 52 weeks (ob-servational period \\[OP\\] I of the study) and can be extended to up to 3 years (OP II of the study). During the observational period, data may be collected approximately every 3 months during the first year (OP I of the study) and thereafter every 6 months (OP II of the study). The present observational plan does not stipulate any study-related procedures or defined time points; only data that are available within the current clinical routine will be collected as documented in the patients' files.","Adult asthmatic patients",[57],{"type":58,"name":59,"description":60,"armGroupLabels":50,"otherNames":61},"OTHER","Trimbow","Trimbow® is a fixed triple therapy containing a long-acting muscarinic antago-nist (LAMA, Glycopyrronium), a long-acting beta-adrenergic agonist (LABA, Formoterol) and an inhaled corticosteroid (ICS, beclomethasone). Trimbow® has an extra-fine formulation delivered as a controlled dosage aerosol. Trim-bow® is to be applied in accordance with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC) in each country.",[62],"Trimbow®",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":50,"email":68},"Tomasz Debowski, Md Phd","CONTACT","+48-800 506 122 982","t.debowski@chiesi.com",{"name":70,"role":66,"phone":71,"phoneExt":50,"email":72},"Maciej Wojakiewicz, Phd","+48-800 697 400 054","m.wojakiewicz@chiesi.com",[74],{"facility":75,"status":76,"city":77,"state":50,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Indywidualna Specjalistyczna Praktyka Lekarska","RECRUITING","Tarnowskie Góry","42-609","Poland","PL",{"type":82,"coordinates":83},"Point",[84,85],18.86147,50.44548,{"lat":85,"lon":84},[88],{"name":89,"role":66,"phone":90,"phoneExt":91,"email":92},"Szymon Płaczek, MD","607-931-761","+48","placzek@interia.pl",{"type":94,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[96],{"name":97,"class":6},"Gesellschaft für Therapieforschung mbH","100559733",false,"NCT06567977","TriMaximize: A Multicentre, Prospective, Non-interventional Trial in Asthma Patients","TriMaximize: A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS\u002FLABA\u002FLAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes.","Trimaximize PL","Inclusion Criteria:\n\n* Patients ≥ 18 years of age,\n* Patients with confirmed leading diagnosis of asthma with or without concomitant COPD,\n* Physician decision to start fixed triple therapy with ICS\u002FLABA\u002FLAMA (Trimbow® MS or HS) according to its current authorised indication. The treatment decision must be made independently from participation in this NIS,\n* Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study.\n\nExclusion Criteria:\n\n• Participation in an interventional clinical trial within 30 days prior to en-rolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.","ALL",{"count":107,"type":108},60,"ESTIMATED","OBSERVATIONAL","TriMaximize: A multicentre, prospective, non-interventional trial monitoring therapy pathways of asthma patients treated with an extra-fine ICS\u002FLABA\u002FLAMA single-inhaler triple therapy in a real-world setting and characterizing the effects on health-related outcomes.",[112],"Asthma","2024-08-20",{"date":115,"type":116},"2024-08-23","ACTUAL",{"date":118,"type":108},"2024-08",{"date":120,"type":108},"2025-08-01",{"name":5,"class":6},1]