[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632050":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":53,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":18,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":78,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RSV group","ACTIVE_COMPARATOR","Patients who will receive RSV vaccination and standard of care",[13],"Biological: RSV vaccination (Arexvy, GlaxoSmithKline)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care (SOC) group","NO_INTERVENTION","Patients who will receive standard of care (no RSV vaccination)",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BIOLOGICAL","RSV vaccination (Arexvy, GlaxoSmithKline)","A single dose of RSV vaccination (Arexvy, GlaxoSmithKline) at the start of study",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Ka Pang Chan, MBChB","CONTACT","35052211","chankapang@cuhk.edu.hk",[32],{"facility":33,"status":18,"city":34,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Prince of Wales Hospital","Shatin","Hong Kong","HK",{"type":38,"coordinates":39},"Point",[40,41],114.18333,22.38333,{"lat":41,"lon":40},[44,45],{"name":27,"role":28,"phone":18,"phoneExt":29,"email":30},{"name":46,"role":28,"phone":47,"phoneExt":18,"email":48},"Karen Yiu","35053532","ysyiu@cuhk.edu.hk",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Ka Pang Chan","Assistant Professor",[54],{"name":55,"class":6},"The University of Hong Kong","100632050","phase-4-rsv-vaccination-to-reduce-recurrent-aecopd-100632050",false,"NCT07508644","RSV Vaccination to Reduce Recurrent AECOPD","Open-label, Multicenter Trial of RSV Vaccination to Reduce Moderate-to-severe Exacerbations in COPD Frequent Exacerbators: Clinical Effectiveness and RSV-specific Immune Responses","Inclusion Criteria:\n\n* Age 50 years or older\n* Spirometry evidence of airflow obstruction (post-bronchodilator FEV1\u002FFVC \\\u003C0.70)\n* Current or former smoker who had accrued a ≥10 pack-year smoking history\n* Frequent COPD exacerbator, as defined by at least ≥2 moderate or ≥1 severe AECOPD in the 12 months prior to screening \\[31,32\\]\n* On dual LABD (LABA and LAMA) using the same inhaler\u002Fdevice for ≥8 weeks\n* Up-to-date influenza and pneumococcal vaccination received at least 1 month prior to screening\n\nExclusion Criteria:\n\n* Coexisting significant pulmonary disease predominating the respiratory symptoms (e.g. asthma, bronchiectasis)\n* Life expectancy shorter than 1 year due to serious or unstable chronic illness (e.g. advanced lung cancer)\n* Refused to receive RSV vaccine (for the RSV group only)\n* Received RSV vaccine of any brand before\n* Immunocompromised or long-term steroid user (≥10mg\u002Fday prednisolone or equivalent for ≥2 weeks), which may affect the RSV vaccine efficacy\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine\n* Pregnant or lactating (females not yet menopausal must have a negative pregnancy test before receiving the RSV vaccination)\n* Unable to provide informed consent","ALL","50 Years",{"count":66,"type":67},320,"ESTIMATED","INTERVENTIONAL",[70],"PHASE4","Objectives: To determine whether respiratory syncytial virus (RSV) vaccination reduces the rate of all-cause moderate-to-severe acute exacerbations of COPD (AECOPD) in high-risk patients, and to characterise RSV-specific infection and immune responses in this population.\n\nHypothesis: RSV vaccination in COPD frequent exacerbators receiving dual long-acting bronchodilators will reduce all-cause moderate-to-severe AECOPD by at least 20-25% over 12 months.\n\nDesign and subjects: This multicentre, two-arm, open-label, prospective study will recruit 320 COPD patients with 2 moderate or severe AECOPD in the prior year despite dual long-acting bronchodilator therapy. Eligible subjects will be allocated 1:1 to receive RSV vaccination plus standard care or standard care alone and followed for 12 months.\n\nInterventions: Participants in the vaccine arm will receive a single dose of a licensed RSV vaccine in addition to usual COPD management. Controls will receive usual care without RSV vaccination during the study period.\n\nMain outcome measures: The primary outcome is the rate of all-cause moderate-to-severe AECOPD per patient-year. Secondary outcomes include RSV-positive AECOPD, RSV infection incidence confirmed by virological testing, severe AECOPD requiring hospitalisation, time to first moderate-to-severe AECOPD, and changes in plasma RSV-specific antibody titres over 12 months.\n\nData analysis and expected results: Exacerbation rates will be compared between groups using negative binomial regression with adjustment for key covariates on an intention-to-treat basis. The investigators expect RSV vaccination to achieve a clinically meaningful (20%) reduction in all-cause moderate-to-severe AECOPD and to provide mechanistic insights linking RSV immunity, RSV infection, and exacerbation risk in COPD frequent exacerbators.",[73,74],"COPD","RSV",[76,74,77],"AECOPD","Vaccine","NOT_YET_RECRUITING","2026-04-07",{"date":81,"type":82},"2026-04-13","ACTUAL",{"date":84,"type":67},"2027-07-01",{"date":86,"type":67},"2030-12-31",{"name":5,"class":6},1]