Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients with Severe Asthma on Biologics
NCT ID: NCT06360393
Last Updated: 2024-12-10
Study Results
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Basic Information
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RECRUITING
110 participants
OBSERVATIONAL
2024-05-01
2026-06-30
Brief Summary
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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.
Detailed Description
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Despite the availability of effective inhaled medications, 15% of asthma patients remain uncontrolled on medium to high dose inhaled corticosteroids (ICS) and LABA, comprising difficult-to-treat asthma and severe refractory asthma groups. GINA guidelines stress the importance of assessing adherence and technique before step-up treatment due to associated risks and costs.
Research underscores the efficacy and cost-effectiveness of investing in adherence and technique support, particularly in this population. However, there is limited understanding of ICS adherence during biologic therapy, despite its increasing use. Studies on biologics like mepolizumab suggest associations between ICS adherence and improved outcomes, while data on others like benralizumab are less conclusive.
Indeed, non-adherence and poor technique is widely reported in patients with all severities of asthma and is associated with increased morbidity and economic burden. Objectively assessing and enhancing adherence remains one of the major challenges for physicians, pharmacists and nurses. Limited studies on digital tools for adherence management exist, particularly for pMDIs in combination with spacers. Digital technologies are promising in addressing these challenges, but studies on devices capable of objectively measuring adherence and technique, especially in patients using pMDIs, are lacking. The Smart AeroChamber® device presents an innovative solution, showing potential in clinical trials for asthma and COPD. The Smart AeroChamber® is a CE-certified device. However, its application in severe asthma patients on biologics remains unexplored, presenting an opportunity to enhance adherence support and treatment outcomes in this cost-sensitive population.
The aim:
This study aims to evaluate the feasibility of using a Smart Spacer device in patients with severe asthma who are on biologic therapy. The research aims to achieve several objectives:
1. Assess medication adherence patterns and inhaler technique using the Smart Spacer device and compare the data with traditional adherence measures, such as the Test of Adherence to Inhalers (TAI), and an inhalation technique checklist.
2. Evaluate the association between adherence measured by the Smart Spacer device and various clinical outcomes including exacerbations, use of short-acting beta agonists (SABA) and oral corticosteroids (OCS), Fractional exhaled Nitric Oxide (FeNO) results, blood eosinophil count, and asthma control questionnaire (ACQ) scores.
3. Assess the usability and satisfaction of patients and healthcare providers with the Smart Spacer device, using the System Usability Scale (SUS).
Study Design:
This study adopts a prospective, observational design.
Inclusion Criteria:
Participants eligible for inclusion are adults aged over 18 years, diagnosed with severe asthma by a physician according to GINA guidelines. They must be using a biologic medication (omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab or tezepelumab) and medium or high dose ICS + LABA with or without LAMA and/or SABA via pMDI in combination with a spacer. Additionally, participants must be willing to provide informed consent.
Exclusion Criteria:
Participants are excluded from participation when they are unable to sufficiently understand and read the Dutch language, being pregnant or being terminally ill.
Sample Size:
The study aims to include a total of 110 patients.
Setting:
The study is conducted in five severe asthma clinics across various regions of the Netherlands (Medical Center Leeuwarden, Martini Hospital Groningen, Isala Zwolle, Sint Franciscus Gasthuis, and University Medical Centrer Groningen).
Baseline Assessment:
Participants undergo characterization during an intake visit to the severe asthma clinic, including demographic data, medical history, spirometry tests, FeNO measurement, blood eosinophil count, ACQ assessment, adherence evaluation using TAI, and inhaler technique assessment via checklist. Subsequently, participants receive two fully charged smart spacers, one for each period of three months, along with instructions for use.
Follow-up:
After 4 weeks, participants are contacted to check the functionality of the smart spacer and receive assistance if needed. A follow-up call at 3-months and 9-months into the study remind participants to switch to the next smart spacer. A physical visit is scheduled at the 6-month mark for further assessment, including ACQ administration and collection of smart spacers for replacement.
End of Study Assessment:
At the end of the 12-month study period, participants undergo a final physical visit for assessment of various parameters including FeNO, blood eosinophil count, lung function, ACQ score, inhaler technique, and documentation of exacerbations and OCS use. Smart spacer data analysis is conducted centrally, and feedback is provided to study sites. Additionally, usability and satisfaction surveys are completed by patients and study nurses.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Severe asthma patients on biologics
Participants diagnosed with severe asthma using a biologic medication and medium or high dose ICS + LABA with or without LAMA and/or SABA via pMDI and spacer. Participants are being treated at one of the five severe asthma clinics in The Netherlands.
Smart spacer
Participants' inhalation medication adherence and inhalation technique will be monitored using a smart spacer. Their usual medication regime will be continued and they will not receive information about their adherence or inhalation technique measured by the spacer during the follow-up year (except for any interventions that will be done in standard care).
Interventions
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Smart spacer
Participants' inhalation medication adherence and inhalation technique will be monitored using a smart spacer. Their usual medication regime will be continued and they will not receive information about their adherence or inhalation technique measured by the spacer during the follow-up year (except for any interventions that will be done in standard care).
Eligibility Criteria
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Inclusion Criteria
* Confirmed asthma diagnoses (≥12% and \>200 ml reversibility in FEV1 or positive histamine/methacholine provocation test or FeNO ≥50) according to the asthma guidelines
* Diagnosed with severe, refractory asthma with eligibility for treatment with specific asthma biologics (omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab)
* Using medium or high ICS + LABA +/- LAMA+/-SABA) by pMDI+spacer
* Willing to sign informed consent
Exclusion Criteria
* Inability to sufficiently understand and read the Dutch language
* Current pregnancy
* Currently terminally ill
18 Years
ALL
No
Sponsors
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Trudell Medical International
INDUSTRY
University Medical Center Groningen
OTHER
Responsible Party
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Principal Investigators
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Job FM van Boven, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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Isala
Zwolle, Overijssel, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
Foundation Martini Hospital
Groningen, Provincie Groningen, Netherlands
Stichting Sint Franciscus Vlietland Groep
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Niels Patberg, MD
Role: primary
Akke-Nynke van der Meer, MD, PhD
Role: primary
Maarten van den Berge, MD, PhD
Role: primary
Titia Klemmeier, RN
Role: backup
Huib Kerstjens, MD, PhD
Role: backup
Marjolein J van Es, MD, PhD
Role: primary
Yasemin Türk, MD, PhD
Role: primary
References
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Hekking PW, Wener RR, Amelink M, Zwinderman AH, Bouvy ML, Bel EH. The prevalence of severe refractory asthma. J Allergy Clin Immunol. 2015 Apr;135(4):896-902. doi: 10.1016/j.jaci.2014.08.042. Epub 2014 Oct 16.
McQueen RB, Sheehan DN, Whittington MD, van Boven JFM, Campbell JD. Cost-Effectiveness of Biological Asthma Treatments: A Systematic Review and Recommendations for Future Economic Evaluations. Pharmacoeconomics. 2018 Aug;36(8):957-971. doi: 10.1007/s40273-018-0658-x.
Barry LE, Sweeney J, O'Neill C, Price D, Heaney LG. The cost of systemic corticosteroid-induced morbidity in severe asthma: a health economic analysis. Respir Res. 2017 Jun 26;18(1):129. doi: 10.1186/s12931-017-0614-x.
Hale EM, Greene G, Mulvey C, Mokoka MC, van Boven JFM, Cushen B, Sulaiman I, Brennan V, Lombard L, Walsh J, Plunkett S, McCartan TA, Kerr PJ, Reilly RB, Hughes C, Kent BD, Jackson DJ, Butler M, Counihan I, Hayes J, Faul J, Kelly M, Convery R, Nanzer AM, Fitzgerald JM, Murphy DM, Heaney LG, Costello RW; INCA Research Team. Use of digital measurement of medication adherence and lung function to guide the management of uncontrolled asthma (INCA Sun): a multicentre, single-blinded, randomised clinical trial. Lancet Respir Med. 2023 Jul;11(7):591-601. doi: 10.1016/S2213-2600(22)00534-3. Epub 2023 Mar 21.
d'Ancona G, Kavanagh J, Roxas C, Green L, Fernandes M, Thomson L, Dhariwal J, Nanzer AM, Jackson DJ, Kent BD. Adherence to corticosteroids and clinical outcomes in mepolizumab therapy for severe asthma. Eur Respir J. 2020 May 7;55(5):1902259. doi: 10.1183/13993003.02259-2019. Print 2020 May.
d'Ancona G, Kavanagh JE, Dhariwal J, Hearn AP, Roxas C, Fernandes M, Green L, Thomson L, Nanzer AM, Jackson DJ, Kent BD. Adherence to inhaled corticosteroids and clinical outcomes following a year of benralizumab therapy for severe eosinophilic asthma. Allergy. 2021 Jul;76(7):2238-2241. doi: 10.1111/all.14737. Epub 2021 Jan 26. No abstract available.
Dekhuijzen R, Lavorini F, Usmani OS, van Boven JFM. Addressing the Impact and Unmet Needs of Nonadherence in Asthma and Chronic Obstructive Pulmonary Disease: Where Do We Go From Here? J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):785-793. doi: 10.1016/j.jaip.2017.11.027. Epub 2018 Jan 12.
van Boven JF, Ryan D, Eakin MN, Canonica GW, Barot A, Foster JM; Respiratory Effectiveness Group. Enhancing Respiratory Medication Adherence: The Role of Health Care Professionals and Cost-Effectiveness Considerations. J Allergy Clin Immunol Pract. 2016 Sep-Oct;4(5):835-46. doi: 10.1016/j.jaip.2016.03.007.
O'Dwyer S, Greene G, MacHale E, Cushen B, Sulaiman I, Boland F, Bosnic-Anticevich S, Mokoka MC, Reilly RB, Taylor T, Ryder SA, Costello RW. Personalized Biofeedback on Inhaler Adherence and Technique by Community Pharmacists: A Cluster Randomized Clinical Trial. J Allergy Clin Immunol Pract. 2020 Feb;8(2):635-644. doi: 10.1016/j.jaip.2019.09.008. Epub 2019 Sep 27.
Jansen EM, van de Hei SJ, Dierick BJH, Kerstjens HAM, Kocks JWH, van Boven JFM. Global burden of medication non-adherence in chronic obstructive pulmonary disease (COPD) and asthma: a narrative review of the clinical and economic case for smart inhalers. J Thorac Dis. 2021 Jun;13(6):3846-3864. doi: 10.21037/jtd-20-2360.
Vincken W, Levy ML, Scullion J, Usmani OS, Dekhuijzen PNR, Corrigan CJ. Spacer devices for inhaled therapy: why use them, and how? ERJ Open Res. 2018 Jun 18;4(2):00065-2018. doi: 10.1183/23120541.00065-2018. eCollection 2018 Apr.
Price DB, Roman-Rodriguez M, McQueen RB, Bosnic-Anticevich S, Carter V, Gruffydd-Jones K, Haughney J, Henrichsen S, Hutton C, Infantino A, Lavorini F, Law LM, Lisspers K, Papi A, Ryan D, Stallberg B, van der Molen T, Chrystyn H. Inhaler Errors in the CRITIKAL Study: Type, Frequency, and Association with Asthma Outcomes. J Allergy Clin Immunol Pract. 2017 Jul-Aug;5(4):1071-1081.e9. doi: 10.1016/j.jaip.2017.01.004. Epub 2017 Mar 9.
Normansell R, Kew KM, Mathioudakis AG. Interventions to improve inhaler technique for people with asthma. Cochrane Database Syst Rev. 2017 Mar 13;3(3):CD012286. doi: 10.1002/14651858.CD012286.pub2.
Dierick BHJ, Achterbosch M, Been-Buck S, Klemmeier T, van de Hei SJ, Hagedoorn P, Kerstjens HAM, Kocks JWH, van Boven JFM. Can electronic monitoring with a digital smart spacer support personalised medication adherence and inhaler technique education in patients with asthma?: Protocol of the randomised controlled OUTERSPACE trial. BMJ Open. 2022 Jun 13;12(6):e059929. doi: 10.1136/bmjopen-2021-059929.
Dierick BJH, Been-Buck S, Klemmeier T, Hagedoorn P, van de Hei SJ, Kerstjens HAM, Kocks JWH, Zijp TR, Wessels AMA, Touw DJ, van Boven JFM. Digital spacer data driven COPD inhaler adherence education: The OUTERSPACE proof-of-concept study. Respir Med. 2022 Sep;201:106940. doi: 10.1016/j.rmed.2022.106940. Epub 2022 Jul 31.
Eikholt AA, Wiertz MBR, Hew M, Chan AHY, van Boven JFM. Electronic monitoring devices to support inhalation technique in patients with asthma: A Narrative Review. Curr Treat Options Allergy. 2023; 10:28-52 doi: 10.1007/s40521-023-00328-7.
Other Identifiers
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17384
Identifier Type: -
Identifier Source: org_study_id