protocolSection identificationModule nctId: NCT06360393, orgStudyIdInfo id: 17384, briefTitle: Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients With Severe Asthma on Biologics, acronym: OUTERSPACE-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: Trudell Medical International, descriptionModule briefSummary: Severe refractory asthma affects about 3.5% of asthma patients, often necessitating biologic therapy in addition to standard treatment. However, little is understood about maintenance and reliever inhalation medication adherence in these cases which might impact overall biologic response. Objectively monitoring inhalation medication adherence remains a significant challenge. The Smart AeroChamber® device, capable of measuring adherence and inhalation technique, is untested in severe asthma patients on biologics, presenting a potentially cost-effective solution to monitor adherence and better understand treatment response.This study aims to assess the feasibility of the Smart AeroChamber® device in severe asthma patients on biologic therapy, with objectives to:1. Evaluate inhalation medication adherence patterns and inhaler technique, and comparing that adherence data with traditional measures e.g. the Test of Adherence to Inhalers (TAI), and an inhalation technique checklist.2. Investigate the association between inhaled medication adherence and clinical outcomes such as exacerbations, short-acting beta-agonists (SABA) use, oral corticosteroids use (OCS), Fractional Exhaled Nitric Oxide (FeNO), blood eosinophil count, and Asthma Control Questionnaire (ACQ) scores.3. Assess patient and healthcare provider satisfaction and usability of the Smart AeroChamber® device.The study design is prospective and observational, with a sample size of 110 adult patients diagnosed with severe asthma using biologic therapy. Participants will be followed for 12 months, during which they will receive Smart AeroChamber® devices. These devices will measure medication adherence and inhaler technique, and undergo assessments of clinical outcomes at regular intervals. Usability and satisfaction will also be evaluated using the Systems Usability Scale (SUS) in patients and healthcare professionals.The study will be conducted across five severe asthma clinics in the Netherlands. Data analysis will involve comparing the inhalation medication adherence data with traditional measures for adherence and inhalation technique, assessing clinical outcomes, and evaluating usability and satisfaction. The findings from this study will provide insights into the feasibility and effectiveness of using digital devices like the Smart AeroChamber® to support medication adherence and possibly improve outcomes in patients with severe asthma on biologic therapy., conditionsModule conditions: Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Smart spacer, outcomesModule primaryOutcomes measure: Comparative analysis of smart spacer medication adherence and inhaler technique against Test of Adherence to Inhalers (TAI-12), primaryOutcomes measure: Comparison of smart spacer medication adherence patterns (adherence and inhaler technique) with inhaler checklist examined by pulmonologist or pulmonary nurse, secondaryOutcomes measure: Assessing the association of smart spacer assessed adherence with annual exacerbation rate, secondaryOutcomes measure: Assessing the association of smart spacer assessed adherence with reliever inhaler use (e.g. SABA), secondaryOutcomes measure: Assess the association of smart spacer assessed adherence with oral corticosteroids use, secondaryOutcomes measure: Assess the association of smart spacer assessed adherence with FeNO results, secondaryOutcomes measure: Assess the association of smart spacer assessed adherence with blood eosinophils, secondaryOutcomes measure: Assess the association of smart spacer assessed adherence with asthma control (ACQ-6), secondaryOutcomes measure: Assess the association of smart spacer assessed adherence with spirometry results, otherOutcomes measure: Assess usability and patient satisfaction using the System Usability Scale, otherOutcomes measure: Assess usability and healthcare provider satisfaction using the System Usability Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medisch Centrum Leeuwarden, city: Leeuwarden, state: Friesland, zip: 8934AD, country: Netherlands, contacts name: Akke-Nynke van der Meer, MD, PhD, role: CONTACT, phone: +31 58 286 3875, email: a.n.van.der.meer@mcl.nl, geoPoint lat: 53.20139, lon: 5.80859, locations facility: Isala, city: Zwolle, state: Overijssel, zip: 8025AB, country: Netherlands, contacts name: Niels Patberg, MD, role: CONTACT, email: k.w.patberg@isala.nl, geoPoint lat: 52.5125, lon: 6.09444, locations facility: Stichting Sint Franciscus Vlietland Groep, city: Rotterdam, state: Zuid-Holland, zip: 3118JH, country: Netherlands, contacts name: Yasemin Türk, MD, PhD, role: CONTACT, phone: +31 10 461 6161, email: yasemin.turk@Franciscus.nl, geoPoint lat: 51.9225, lon: 4.47917, locations facility: University Medical Center Groningen, city: Groningen, zip: 9713GZ, country: Netherlands, contacts name: Maarten van den Berge, MD, PhD, role: CONTACT, phone: +31 6 24450194, email: m.van.den.berge@umcg.nl, contacts name: Titia Klemmeier, RN, role: SUB_INVESTIGATOR, contacts name: Huib Kerstjens, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 53.21917, lon: 6.56667, locations facility: Foundation Martini Hospital, city: Groningen, zip: 9728NT, country: Netherlands, contacts name: Marjolein J van Es, MD, PhD, role: CONTACT, phone: +31 50 524 5245, email: m.vanes@mzh.nl, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False