BMC pulmonary medicine · 2026
Study protocol: a 52-week, multicentre, observational, prospective study on the use of a smart platform connected to a single-inhaler triple therapy (ICS/LABA/LAMA) to evaluate effectiveness on treatment adherence and inhaler technique in patients with poorly controlled asthma.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Baekdal Jonas Aggerholm, Krogh Nicolai, Sakhare Gajanan, Bendstrup Elisabeth, Ulrik Charlotte Suppli, Schmid Johannes Martin
Аннотация
BACKGROUND: Good adherence to controller medication and correct inhaler technique is essential for effective asthma management. However, many patients struggle with these aspects, leading to poor symptom control and a higher risk of exacerbations. This study (SiASMARTer) aims to evaluate the impact of the SiA®SMARTer platform - a digital smart platform consisting of an app and an add-on module connected to a pressurized metered-dose inhaler delivering triple therapy (ICS/LABA/LAMA) - on improving adherence and inhaler technique in patients with poorly managed inflammation in asthma (defined as fractional exhaled nitric oxide [FeNO] > 25 ppb).
METHODS: This observational study will enrol 60 patients from two sites in Denmark. At baseline, participants will begin using the SiA®SMARTer platform, which includes, on the patient side a smart inhaler cap, a patient app and on the physician side a dashboard. The primary endpoint, with follow-up at 12 and 52 weeks, is the platform's effect on FeNO levels. Secondary endpoints will include changes from baseline in treatment adherence and inhaler technique scores, Asthma Control Test scores, Mini Asthma Quality of Life Questionnaire scores, lung function parameters, FeNO category distribution, exacerbation rates, short-acting β2-agonist use, and patient-reported satisfaction with the SiA®SMARTer platform. Data on adherence and inhaler technique will be continuously collected through the SiA®SMARTer platform, and adverse events will be monitored.
DISCUSSION: This study may offer valuable insights into whether a digital platform can enhance adherence and inhaler technique, and by that improve asthma control. Additionally, it may help discriminate patients requiring therapy escalation from those with poor control due to non-adherence or incorrect inhaler technique.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06908421, Registration date: 2025-03-26.
METHODS: This observational study will enrol 60 patients from two sites in Denmark. At baseline, participants will begin using the SiA®SMARTer platform, which includes, on the patient side a smart inhaler cap, a patient app and on the physician side a dashboard. The primary endpoint, with follow-up at 12 and 52 weeks, is the platform's effect on FeNO levels. Secondary endpoints will include changes from baseline in treatment adherence and inhaler technique scores, Asthma Control Test scores, Mini Asthma Quality of Life Questionnaire scores, lung function parameters, FeNO category distribution, exacerbation rates, short-acting β2-agonist use, and patient-reported satisfaction with the SiA®SMARTer platform. Data on adherence and inhaler technique will be continuously collected through the SiA®SMARTer platform, and adverse events will be monitored.
DISCUSSION: This study may offer valuable insights into whether a digital platform can enhance adherence and inhaler technique, and by that improve asthma control. Additionally, it may help discriminate patients requiring therapy escalation from those with poor control due to non-adherence or incorrect inhaler technique.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06908421, Registration date: 2025-03-26.
Предметные рубрики MeSH
AdultFemaleHumansMaleMiddle AgedAdherence InterventionsAdministration, InhalationAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAnti-Asthmatic AgentsAsthmaDenmarkMedication AdherenceMetered Dose InhalersMobile ApplicationsProspective StudiesObservational Studies as TopicMulticenter Studies as Topic