[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613250":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":52,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":18,"enrollmentInfo":64,"targetDuration":18,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":84,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Hôpital Fribourgeois","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Participants receive a structured, physiotherapist-led inhaler-optimization program in addition to their usual COPD care. The program includes three in-person visits at approximately Months 3, 6, and 9. During each visit, the physiotherapist assesses inhaler technique using device-specific placebo inhalers, measures peak inspiratory flow (PIF) with the In-Check DIAL® device, and provides individualized teach-to-goal inhaler education. If persistent critical errors or suboptimal PIF are identified, a recommendation is made to the treating physician to adapt the inhaler type. All participants undergo baseline and 12-month assessments identical to the control group.",[13],"Behavioral: Physiotherapist-Led Inhaler Optimization Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Outpatient COPD Care","NO_INTERVENTION","Participants receive standard outpatient COPD management from their treating physician. Usual care may include medication adjustments and inhaler review at the physician's discretion, but no structured physiotherapy sessions are added. Participants complete baseline and 12-month assessments identical to the intervention group, including inhaler technique evaluation, PIF measurement, respiratory questionnaires, and lung function testing.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Physiotherapist-Led Inhaler Optimization Program","This intervention consists of a structured, physiotherapist-led inhaler-optimization program delivered over 12 months in addition to usual outpatient COPD care. Participants attend three face-to-face sessions at Months 3, 6, and 9. During each session, a trained physiotherapist evaluates inhaler technique using device-specific placebo inhalers and validated checklists, measures peak inspiratory flow (PIF) with the In-Check DIAL® device adjusted to the resistance of each inhaler, and provides individualized teach-to-goal education with iterative demonstration and feedback until correct technique is achieved. If the participant continues to demonstrate critical errors or cannot generate an adequate PIF for their prescribed device, the physiotherapist notifies the treating physician and recommends adapting the inhaler type. The intervention does not include medication changes or pharmacologic treatment.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Gaël Grandmaison, MD","CONTACT","+41 26 306 23 68","gael.grandmaison@h-fr.ch",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Sandrine Foucras","+ 41 26 306 21 06","sandrine.froucras@h-fr.ch",[36],{"facility":37,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"HFR Fribourg","Fribourg","Canton of Fribourg","1700","Switzerland","CH",{"type":44,"coordinates":45},"Point",[46,47],7.15128,46.80237,{"lat":47,"lon":46},[50,51],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100613250","assessing-and-improving-misuse-of-inhalers-in-copd-outpatients-100613250",false,"NCT07264140","Assessing and Improving Misuse of Inhalers in COPD Outpatients","Assessing and Improving Misuse of Inhalers in Outpatients With COPD - The AIMO COPD Study","AIMO COPD","Inclusion Criteria:\n\n1. Age ≥18 years\n2. COPD confirmed by spirometry (FEV1\u002FFVC \\\u003C0.7)\n3. Current use of at least one maintenance inhaler\n4. Follow-up at the outpatient pneumology clinic of HFR Fribourg\n5. Ability to provide written informed consent\n\nExclusion Criteria:\n\n1. Inability to provide informed consent (e.g. severe cognitive impairment, advanced psychiatric disorder, unresolved language barrier)\n2. Life expectancy \\\u003C12 months\n3. Predominant other chronic lung disease (e.g. asthma, fibrosis)\n4. Any condition preventing completion of study procedures\n5. Ongoing participation in another interventional trial on inhaler technique","ALL","18 Years",{"count":65,"type":66},116,"ESTIMATED","INTERVENTIONAL",[69],"NA","Chronic obstructive pulmonary disease (COPD) is a common long-term lung disease that causes breathlessness, cough, and frequent flare-ups. Most patients with COPD use inhaled medications every day. However, many people do not use their inhalers correctly, or they cannot generate the right inspiratory flow for their device. When inhalers are used incorrectly, the medication does not reach the lungs properly, symptoms worsen, and the risk of exacerbations increases.\n\nThis pragmatic randomized controlled trial evaluates whether a structured physiotherapist-led inhaler optimization program improves inhaler use in routine outpatient COPD care. The program is delivered by trained physiotherapists over 12 months and includes three in-person sessions. During these sessions, the physiotherapist evaluates the patient's inhaler technique using placebo devices, measures the patient's peak inspiratory flow with the In-Check DIAL® device, and provides individualized \"teach-to-goal\" education to help patients use their inhalers correctly. If the patient continues to make critical errors or cannot generate the appropriate inspiratory flow for their inhaler, the physiotherapist may recommend adapting the type of inhaler to better match the patient's abilities.\n\nParticipants will be randomly assigned to one of two groups. The intervention group will receive the structured program in addition to their usual COPD care. The control group will continue with usual outpatient care without the physiotherapist-led sessions. All participants will complete baseline and 12-month assessments, which include inhaler technique evaluation, inspiratory flow measurement, respiratory questionnaires, and lung function tests. Telephone follow-up calls will be performed at months 2, 5, and 8 to monitor symptoms, inhaler use, and adherence.\n\nThe main outcome of the study is the proportion of inhalers used incorrectly at 12 months. Incorrect use is defined as at least one critical inhaler technique error or an inspiratory flow that is too low or too high for the patient's device. Secondary outcomes include changes in respiratory symptoms, health status, adherence to inhaled treatment, patient satisfaction with inhalers, confidence in inhaler use, and the number of COPD exacerbations or hospitalizations during the study.\n\nThis research may help improve everyday inhaler use in people with COPD and support more personalized inhaler selection in routine clinical care. Although participants may not benefit directly, the study poses minimal risks and may contribute to future improvements in COPD management.",[72],"Chronic Obstructive Pulmonary Disease (COPD)",[74,75,76,77,78,79,80,81,82,83],"COPD","Chronic Obstructive Pulmonary Disease","Inhaler Technique","Inhaler Misuse","Peak Inspiratory Flow","Inhaler Education","Inhaler Optimization","Respiratory Physiotherapy","In-Check DIAL","Outpatient COPD Care","NOT_YET_RECRUITING","2026-05-11",{"date":87,"type":88},"2026-05-14","ACTUAL",{"date":90,"type":66},"2026-06-01",{"date":92,"type":66},"2029-12-31",{"name":5,"class":6},1]