[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Chiesi Hungary Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100580686","the-importance-of-tailored-education-and-device-handling-for-asthmatic-patients-100580686",false,"NCT06840522","The Importance of Tailored Education And Device Handling for Asthmatic Patients","TEACH","Inclusion Criteria:\n\n1. Physician-confirmed clinical diagnosis of asthma according to GINA guidelines\n2. Uncontrolled asthma according to the physician's clinical assessment despite the use of appropriate therapy of Step 2 or 3, according to GINA guidelines\n3. Patients who are eligible for the use of Foster Nexthaler 100\u002F6 mcg according to the SmPC\n4. Inhaled asthma therapy was changed independent from the study to Foster Nexthaler 100\u002F6 mcg DPI maximum 1 week prior to OR on the day of study inclusion\n5. Spirometry was performed as part of routine clinical practice\n6. Patient able to use their Foster Nexthaler device properly after education on inhaler technique\n7. Patient provided written, informed consent to study participation\n8. Patient ≥ 18 years of age\n\nExclusion Criteria:\n\n1. Participation in any clinical trial, 30 days prior to inclusion\n2. Patient is unable to execute a spirometry test\n3. Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.\n4. Patients with other significant diseases of the respiratory system or other organ systems that may significantly contribute to asthma symptoms (such as severe heart failure, symptomatic anaemia, functional respiratory disorders, malignant diseases etc.) according to the physician's clinical assessment.\n5. Continuous use of oral corticosteroids (\\>5 mg prednisolone\u002Fday or \\>4 mg methylprednisolone\u002Fday)\n6. Use of continuous oxygen therapy\n7. Use of biologics for asthma treatment\n8. All exclusion criteria listed in Foster Nexthaler 100\u002F6 SmPC","ALL","18 Years",{"count":19,"type":20},250,"ESTIMATED","OBSERVATIONAL","Significant advancements have been made in asthma medication over the past decades. Highly effective treatments are available for patients; however, both adherence and proper device usage remain below the desired levels, based on our experience and literature data. Despite the availability of numerous excellent drug-device combinations, personalized treatment for patients is still not adequately addressed.\n\nIn the present study, the aim is to improve patient compliance and educate symptomatic, partially, or uncontrolled asthma patients on the correct use of a specific inhalation device (Nexthaler). Considering the characteristics of the medication, the patient's lung function data, inhalation technique, and drug retention time can help estimate the expected lung deposition of the medication. By refining the inhalation technique under the guidance of the treating physician, it is hypothesized that the expected therapeutic effects of the medication may improve.",[24],"Asthma",[26,27],"Inhalation treatment","Lung deposition","NOT_YET_RECRUITING","2025-02-21",{"date":31,"type":32},"2025-02-24","ACTUAL",{"date":34,"type":20},"2025-03-01",{"date":36,"type":20},"2026-08-01",{"name":38,"class":39},"Chiesi Hungary Ltd.","INDUSTRY",6,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100568205","investigation-of-fixed-triple-inhaled-combination-in-asthmatic-patients-in-a-real-life-setting-100568205","NCT06678191","Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting","Effectiveness of BDP\u002FFF\u002FG 172\u002F5\u002F9 Fixed Triple Combination on Symptom Scores in Asthma Patients After 6 Months Treatment","STRENGTH","INCLUSION CRITERIA:\n\n* Physician-confirmed clinical diagnosis of asthma according to GINA guidelines and treated for at least 3 years before inclusion\n* Patients ≥ 18 years of age in ambulatory care\n* Uncontrolled asthma according to the physician's clinical assessment despite the use of\n\n  1. LABA - high dose ICS OR\n  2. LABA - high-dose ICS + LAMA multi-inhaler triple therapy for a minimum of three months.\n* Patients who are eligible for the use of Trimbow 172\u002F5\u002F9 μg pMDI according to the SmPC and the financing protocol for asthma\n\n  1. At least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months\n  2. Uncontrolled asthma (ACT≤15)\n  3. FEV1\\\u003C80% at baseline\n* Inhaled asthma therapy was changed to Trimbow 172\u002F5\u002F9 μg pMDI no more than 1 week prior to OR on the day of study inclusion\n* Patient provided written, informed consent to study participation\n\nEXCLUSION CRITERIA:\n\n* Participation in any clinical trial within 30 days prior to enrolment\n* Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment\n* Another respiratory condition, apart from asthma or COPD, that may interfere with the effectiveness of the treatment studied AND\u002FOR another important clinical situation that may interfere with patient's compliance with the treatment.\n* Continuous use of oral (\\>5 mg prednisolone\u002Fday OR \\>4 mg methylprednisolone\u002Fday) OR intravenous corticosteroids CHMED\\_2024\u002F01 Prof. Dr. Lilla Tamási 8(17)\n* Use of continuous oxygen therapy\n* Any malignant disease in the last 5 years\n* Tuberculosis (active or anamnestic)\n* Actual or previous use of biologics for asthma treatment in the past 12 months\n* All exclusion criteria listed in Trimbow 172\u002F5\u002F9 μg pMDI SmPC",{"count":50,"type":20},800,"The mainstay of asthma treatment are ICSs, mostly combined with LABA. In the past decade LAMA had been accepted as an add-on treatment for patients on GINA treatment Steps 4 and 5. Recently, RCTs proved the efficacy and safety of fixed triple combinations of moderate and high dose of ICS and LABA, LAMA in a very selected asthmatic population, resulting in the market authorisation of these products. However, there is a lack of evidence on the real-world effectiveness of these therapies, especially with regards to improvement in symptom scores and quality of life. Also, there is scarcity of data regarding the phenotypes of asthmatics who benefit the most from the use of fixed triple combinations.",[53,54],"Asthma, Chronic Obstructive Pulmonary Disease (COPD)","Asthma Bronchiale",[56,57,58],"Asthma therapy","Fixed triple inhalation treatment","Trimbow","RECRUITING","2024-11-20",{"date":62,"type":32},"2024-11-22",{"date":64,"type":32},"2024-10-24",{"date":66,"type":20},"2027-08-31",{"name":38,"class":39},45,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100496469","assessment-of-the-pharmacokinetic-profile-of-tacrolimus-medications-and-their-relation-to-effectiveness-and-safety-in-liver-transplant-patients-100496469","NCT05744635","Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients","Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients","LTA","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age\n2. Patients after liver- or simultaneous liver and kidney transplantation\n3. Having received a tacrolimus containing immunosuppressant therapeutic regimen at least for four weeks (induction therapy), and TL is within 5-20 ng\u002Fml before inclusion\n4. Patients signed an informed consent form for use of their pseudonymised clinical data within the present non-interventional trial.\n\nExclusion Criteria:\n\n1. Participation in any clinical trial, 30 days prior to inclusion\n2. The patients received liver allograft more than 6 months before inclusion\n3. Hospitalisation due to infection, acute rejection, or graft disfunction 2 weeks prior to enrolment\n4. Chronic graft insufficiency in the patient's history\n5. Use of medications 2 weeks prior to enrolment, or the need for continuous use of medications that are known to significantly affect the pharmacokinetics of tacrolimus containing medications (as CYP3A4 inducers: rifampin, carbamazepine, phenobarbital, and phenytoin, or CYP3A4 inhibitors: erythromycin, ketoconazole, clarithromycin, and verapamil containing medication)\n6. Presence of the following comorbidities:\n\n   1. Diseases affecting adherence to therapy (Chronic neurologic conditions, Psychiatric diseases)\n   2. Diseases affecting drug absorption and metabolism (Inflammatory bowel disease, Chronic inflammatory diseases of bile ducts, Presence of ascites due to any disease)\n7. Patients on waiting list for re-transplantation",{"count":78,"type":20},110,"The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients. The main question\\[s\\] it aims to answer are:\n\n* Differences in pharmacokinetic parameters of tacrolimus containing medicinal products (TL, TDD and their ratio - C\u002FD)\n* Changes in liver function parameters compared to baseline.\n* Change in the estimated glomerular filtration rate (eGFR) compared to baseline.\n* To assess the possible relation of liver function parameters and eGFR to C\u002FD (blood concentration and daily dosage)\n* Incidence of acute graft rejection during the study\n* Incidence of BK and cytomegalovirus (CMV) infection during the study\n* To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C\u002FD)\n* To assess the patient-adherence of therapy based on the BAASIS questionnaire, and prescription filled by individual patients, based on electronic health-care record.\n\nParticipants will not have to undergo any additional clinical visits or tests except which are required in routine clinical care",[81],"Liver Failure",[83,84,85],"Liver transplantation","Immunosuppression","Tacrolimus","2024-08-21",{"date":88,"type":32},"2024-08-22",{"date":90,"type":32},"2023-05-10",{"date":92,"type":20},"2026-06-01",{"name":38,"class":39},2,""]