[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595317":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":41,"responsibleParty":151,"collaborators":26,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":26,"eligibilityCriteria":161,"healthyVolunteers":157,"sex":162,"minAge":163,"maxAge":26,"enrollmentInfo":164,"targetDuration":26,"studyType":167,"phases":168,"briefSummary":170,"conditions":171,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"First Affiliated Hospital of Ningbo University","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Therapy Group","ACTIVE_COMPARATOR","Participants will receive standard triple inhaled therapy using a pressurized metered-dose inhaler (ICS\u002FLABA\u002FLAMA). They will receive routine inhalation technique training but will not use a spacer device.",[13],"Drug: pMDI Triple Inhaler Only",{"label":15,"type":16,"description":17,"interventionNames":18},"Spacer Group","EXPERIMENTAL","Participants will receive the same standard triple inhaled therapy via pMDI (ICS\u002FLABA\u002FLAMA) plus a valved mouthpiece spacer. Inhalation technique training will include proper spacer usage, including attachment, mouth seal, actuation timing, and cleaning. The spacer is intended to optimize pulmonary drug delivery, reduce the need for hand-breath coordination, and minimize local side effects.",[19],"Other: pMDI Triple Inhaler and Spacer",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"OTHER","pMDI Triple Inhaler and Spacer","Participants in this group will use a valved mouthpiece spacer in combination with standard triple inhaled therapy delivered by a pressurized metered-dose inhaler (ICS\u002FLABA\u002FLAMA). The spacer device helps reduce the need for hand-breath coordination, prolongs aerosol suspension time, and improves drug delivery to the lungs. Participants will be trained in proper spacer use, including device attachment, timing of actuation and inhalation, mouth seal technique, cleaning, and daily maintenance. This intervention aims to optimize inhalation technique, improve treatment adherence, and potentially reduce the incidence of moderate-to-severe exacerbations.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","pMDI Triple Inhaler Only","Participants in the control group will receive a standard fixed-dose combination of inhaled corticosteroid (ICS), long-acting beta-agonist (LABA), and long-acting muscarinic antagonist (LAMA) administered via pressurized metered-dose inhaler (pMDI). No spacer will be used. All participants will receive standardized inhalation technique training at baseline, including hand-held device usage, actuation-inhalation timing, breath-hold, and mouth rinsing. This group represents the current standard-of-care for stable, high-risk COPD or asthma patients as per GOLD and GINA guidelines.",[9],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Chao Cao","CONTACT","+86-0574-87089878","caocdoctor@163.com",{"name":39,"role":35,"phone":36,"phoneExt":26,"email":40},"Shiyi He","shiyihii@163.com",[42,60,73,83,96,106,114,127,141],{"facility":43,"status":44,"city":45,"state":46,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Second Affiliated Hospital of Anhui Medical University","RECRUITING","Hefei","Anhui","China","CN",{"type":50,"coordinates":51},"Point",[52,53],117.28083,31.86389,{"lat":53,"lon":52},[56],{"name":57,"role":35,"phone":58,"phoneExt":26,"email":59},"Jing Ye","0551-63869420","plowchan@126.com",{"facility":61,"status":44,"city":62,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"The Second Affiliated Hospital of Harbin Medical University","Harbin",{"type":50,"coordinates":64},[65,66],126.65,45.75,{"lat":66,"lon":65},[69],{"name":70,"role":35,"phone":71,"phoneExt":26,"email":72},"Dongju Su","0451-86605222","hydsdj@126.com",{"facility":74,"status":44,"city":45,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Anhui Chest Hospital",{"type":50,"coordinates":76},[52,53],{"lat":53,"lon":52},[79],{"name":80,"role":35,"phone":81,"phoneExt":26,"email":82},"Wenjuan Xia","0551-63633507","wenjuanx616@163.com",{"facility":84,"status":44,"city":85,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Beilun District Second People's Hospital","Ningbo",{"type":50,"coordinates":87},[88,89],121.54945,29.87819,{"lat":89,"lon":88},[92],{"name":93,"role":35,"phone":94,"phoneExt":26,"email":95},"Xiaoyong Huang","0574-86835539","bldeyy@126.com",{"facility":97,"status":44,"city":85,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"Ningbo Medical Center Lihuili Hospital",{"type":50,"coordinates":99},[88,89],{"lat":89,"lon":88},[102],{"name":103,"role":35,"phone":104,"phoneExt":26,"email":105},"Biyun Yu","0574-55836114","ybyfish@163.com",{"facility":107,"status":44,"city":85,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":108,"geoPoint":110,"contacts":111},"The First Affiliated Hospital of Ningbo University",{"type":50,"coordinates":109},[88,89],{"lat":89,"lon":88},[112],{"name":34,"role":35,"phone":113,"phoneExt":26,"email":37},"0574-87085151",{"facility":115,"status":44,"city":116,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Ninghai County First Hospital","Ninghai",{"type":50,"coordinates":118},[119,120],121.42472,29.28917,{"lat":120,"lon":119},[123],{"name":124,"role":35,"phone":125,"phoneExt":26,"email":126},"Min Ji","0574-65578371","531668993@qq.com",{"facility":128,"status":129,"city":130,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Taizhou Central Hospital","NOT_YET_RECRUITING","Taizhou",{"type":50,"coordinates":132},[133,134],119.90812,32.49069,{"lat":134,"lon":133},[137],{"name":138,"role":35,"phone":139,"phoneExt":26,"email":140},"Xi Yang","0576-88526000","yangx0603@tzzxyy.com",{"facility":142,"status":44,"city":130,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":143,"geoPoint":145,"contacts":146},"Taizhou Municipal Hospital",{"type":50,"coordinates":144},[133,134],{"lat":134,"lon":133},[147],{"name":148,"role":35,"phone":149,"phoneExt":26,"email":150},"Longxiang Li","0576-88805197","tzmhgcp@163.com",{"type":152,"investigatorFullName":153,"investigatorTitle":154,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Chao Cao, Ph.D.","Principal Investigator","100595317","effect-of-spacer-use-on-exacerbation-risk-in-high-risk-older-adults-with-chronic-airway-diseases-receiving-triple-therapy-100595317",false,"NCT07030881","Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy","Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥65 years, no gender restriction;\n2. Confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on GOLD criteria or bronchial asthma based on GINA criteria;\n3. Currently on stable treatment with fixed-dose combination ICS\u002FLABA\u002FLAMA via pMDI for ≥4 weeks;\n4. History of any of the following in the past 12 months:\n\n   1. ≥1 hospitalization due to exacerbation, or\n   2. ≥2 moderate exacerbations requiring systemic corticosteroids and\u002For antibiotics;\n5. Able to complete inhalation technique training and demonstrate basic communication and device-handling abilities;\n6. Provides written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Use of other inhalation devices as primary therapy (e.g., DPI, SMI, or nebulizer);\n2. Regular use of a spacer device for ≥3 weeks within 3 months prior to enrollment;\n3. Current or recent (within 4 weeks) acute exacerbation not fully resolved;\n4. Severe cognitive impairment (MMSE score \\\u003C18);\n5. Presence of severe systemic comorbidities (e.g., end-stage malignancy, advanced heart failure, hepatic or renal failure);\n6. Participation in another interventional clinical trial;\n7. Inability to use a mouthpiece-based spacer (e.g., structural oral\u002Ffacial abnormalities, severe anxiety);\n8. Known allergy or hypersensitivity to spacer device materials.","ALL","65 Years",{"count":165,"type":166},380,"ESTIMATED","INTERVENTIONAL",[169],"NA","This study evaluates whether adding a spacer device to triple inhaled therapy (ICS\u002FLABA\u002FLAMA via pMDI) can reduce acute exacerbations in elderly patients (≥65 years) with stable chronic airway diseases (COPD or asthma) who are classified as high-risk based on GOLD or GINA guidelines. High risk is defined as ≥1 hospitalization or ≥2 moderate exacerbations in the past 12 months.\n\nDespite receiving triple inhaled therapy, these patients often have poor inhaler technique due to age-related limitations. A spacer may improve drug delivery, adherence, and reduce local side effects.\n\nIn this multicenter, open-label, randomized controlled trial, 380 participants will be assigned to standard therapy with or without a valved spacer. The primary outcome is the 3-month incidence of moderate-to-severe exacerbations. Secondary outcomes include lung function, adherence, inhalation technique, side effects, and patient satisfaction.",[172],"Asthma, COPD","2026-06-23",{"date":175,"type":176},"2026-06-26","ACTUAL",{"date":178,"type":176},"2025-06-17",{"date":180,"type":166},"2027-06-30",{"name":5,"class":6},9]