[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648316":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":47,"collaborators":18,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":18,"maxAge":18,"enrollmentInfo":58,"targetDuration":18,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":68,"whyStopped":18,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","The intervention will be implemented at the hospital level.",[13],"Behavioral: Intervention group",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","No intervention action will be taken at hospital level, even patient level.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","The GDMT pathway targets physicians and specialized nurses for implementation. It ensures that physicians at intervention groups conduct standardized diagnosis and treatment following GDMT, and that specialized nurses deliver patient education and follow-up reminders according to GDMT. This is achieved through regular knowledge training, provision of a series of reminder\u002Fsupport tools, and a bi-weekly (every 12 weeks) monitoring, and feedback system for Key Performance Indicators (KPIs).",[9],[25],{"name":26,"affiliation":27,"role":28},"Kewu Huang","Beijing Chao Yang Hospital","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[36],{"facility":37,"status":18,"city":38,"state":18,"zip":18,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":18},"Northan Jiangsu People's Hospital","Yangzhou","China","CN",{"type":42,"coordinates":43},"Point",[44,45],119.43583,32.39722,{"lat":45,"lon":44},{"type":48,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100648316","impact-of-gdmt-in-uncontrolled-asthma-patients-receiving-mhd-inhaled-corticosteroids--long-acting-2-agonist-100648316",false,"NCT07718724","Impact of GDMT in Uncontrolled Asthma Patients Receiving MHD Inhaled Corticosteroids + Long-acting β2 Agonist","A Prospective, Multicenter, Cluster-Randomized Trial to Evaluate the Impact of Guideline-Directed Medical Therapy in Uncontrolled Asthma Patients Receiving Medium-to-High Dose Inhaled Corticosteroids Plus Long-acting β2 Agonist","PRECISION","Inclusion Criteria:\n\n1. Sign the informed consent form before any study-related procedures;\n2. Age 18-75 years (inclusive) at Visit 0;\n3. Have a written diagnosis of asthma for more than 6 months prior to Visit 0, and have evidence of reversible airflow limitation prior to Visit 0. Evidence of reversible airflow limitation includes: post-bronchodilator increase in Forced Expiratory Volume in 1 second (FEV1) of ≥12% and an absolute increase of ≥200 mL, or average daily diurnal Peak Expiratory Flow (PEF) variability \\>10%, or an increase in FEV1 of ≥12% and an absolute increase of ≥200 mL compared to baseline after 4 weeks of treatment containing ICS, or a positive bronchial provocation test record. If no prior record exists, reversible airflow limitation must be confirmed and documented via a bronchodilator test during Visit 0;\n4. Under the usage of MD\u002FHD ICS-LABA;\n5. Experienced one or more exacerbations within the past year;\n\nExacerbation is defined as meeting any of the following criteria:\n\n1. Use of systemic corticosteroids (or a temporary increase in the stable dose of baseline oral corticosteroids) for at least 3 days; a single injection of a depot long-acting corticosteroid can be considered equivalent to a 3-day course of systemic corticosteroids;\n2. An emergency department or urgent care site visit for asthma (defined as being evaluated and treated in the emergency department or urgent care site for \\\u003C 24 hours) requiring the use of systemic corticosteroids for at least 3 days (as described above);\n3. Hospitalization for asthma (defined as admission to a hospital and\u002For being evaluated and treated in a healthcare facility for ≥ 24 hours).\n\nExclusion Criteria:\n\n1. Previous written diagnosis as \"Severe Asthma\"; Diagnosis of Severe Asthma includes: severe asthma, or related diagnoses containing \"severe asthma\", or \"bronchial asthma (severe)\".\n2. Imaging suggests the presence of bullae or cystic bronchiectasis;\n3. Currently participating in other interventional studies;\n4. Previous use of biologics for asthma treatment;\n5. Using systemic glucocorticoids for other diseases;\n6. History of respiratory tract infection within 4 weeks prior to Visit 0 (upper respiratory tract infections and lower respiratory tract infections);\n7. Any significant disease or disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine\u002Fmetabolic, malignant, psychiatric, or significant physical impairment, etc.) which, in the opinion of the investigator, may put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to comply with GDMT.","ALL",{"count":59,"type":60},540,"ESTIMATED","INTERVENTIONAL",[63],"NA","The primary objective of this study is to evaluate whether GDMT can bring significant benefits to disease management in uncontrolled asthma patients receiving medium- to high-dose ICS-LABA.\n\n* The intervention period will be up to 48 weeks;\n* The frequency of follow-up is every 12 weeks.",[66],"Uncontrolled Asthma",[55],"NOT_YET_RECRUITING","2026-07-16",{"date":71,"type":72},"2026-07-22","ACTUAL",{"date":74,"type":60},"2026-08-15",{"date":76,"type":60},"2028-04-30",{"name":5,"class":6},1]