Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients with Severe Asthma on Biologics

NCT06360393 | Recruiting

• 1 other identifier: 17384
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 5

Brief Summary

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. 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. 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. 3.Assess patient and healthcare provider satisfaction and usability of the Smart AeroChamber® device.

Conditions

Asthma

Keywords

Severe asthma; Biologics; Digital home monitoring; Digital spacer; Adherence; Inhalation technique

Outcome Measures

Primary Outcomes (2)

• Comparative analysis of smart spacer medication adherence and inhaler technique against Test of Adherence to Inhalers (TAI-12)

  An evaluation of the inhalation adherence patterns and inhaler techniques of patients utilizing smart spacer devices in comparison to traditional inhaler usage assessed by the Test of Adherence to Inhalers (TAI-12). TAI is a questionnaire which identifies patients with low adherence, determines the degree of adherence and gives an idea of the type or pattern of non-compliance. The TAI-12 consists of 10 questions for the patient and 2 questions for the healthcare provider and identifies patients with poor adherence and their degree of adherence. The scoring for the patient part is: for each question ranges from 1 to 5 (1 = worst compliance to 5 = best compliance). All items provide a total score of between 10 (minimum) and 50 (maximum). A higher score is related to better adherence. The scoring of the healthcare provider part is: a minimum of 2 points and a maximum of 4 points. A higher score also relates to a better adherence.

  TAI is measured at baseline and 12 months

• Comparison of smart spacer medication adherence patterns (adherence and inhaler technique) with inhaler checklist examined by pulmonologist or pulmonary nurse

  An evaluation of the inhalation adherence patterns and inhaler techniques of patients utilizing smart spacer devices in comparison to traditional inhaler usage assessment by healthcare professionals using an inhalation technique checklist. The inhalation technique checklist is created by following the national inhalation technique guidelines by the Lung Foundation in The Netherlands (Long Alliantie Nederland, LAN), specifically for using a pMDI in combination with a spacer. The checklist consists of 8 points to assess the inhalation technique on (from the preparation of the device, to the positioning of the device and posture of the patient, and the actual inhalation).

  Inhaler checklist is assessed at baseline and 12 months

Secondary Outcomes (7)

• Assessing the association of smart spacer assessed adherence with annual exacerbation rate

  Over a period of 12 months

• Assessing the association of smart spacer assessed adherence with reliever inhaler use (e.g. SABA)

  Over a period of 12 months

• Assess the association of smart spacer assessed adherence with oral corticosteroids use

  Over a period of 12 months

• Assess the association of smart spacer assessed adherence with FeNO results

  FeNO is measured at baseline and 12 months

• Assess the association of smart spacer assessed adherence with blood eosinophils

  Blood eosinophils measured at baseline and 12 months

Other Outcomes (2)

• Assess usability and patient satisfaction using the System Usability Scale

  SUS is measured at 12 months

• Assess usability and healthcare provider satisfaction using the System Usability Scale

  SUS is measured at 12 months

Study Arms (1)

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.

Device: Smart spacer

Interventions

Smart spacer DEVICE

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).

Severe asthma patients on biologics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants 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, or dupilumab) and medium or high dose ICS + LABA with or without LAMA and/or SABA via pMDI and spacer.

You may qualify if:

• Age ≥ 18 years.
• 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

You may not qualify if:

• The use of the Symbicort Aerosol or the Trixeo Aerosphere in combination with a spacer (these inhalers are not compatible with the smart spacer)
• Inability to sufficiently understand and read the Dutch language
• Current pregnancy
• Currently terminally ill

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Trudell Medical International: collaborator

Study Sites (5)

Isala

Zwolle, Overijssel, 8025AB, Netherlands

RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, 8934AD, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

RECRUITING

Foundation Martini Hospital

Groningen, Provincie Groningen, 9728NT, Netherlands

RECRUITING

Stichting Sint Franciscus Vlietland Groep

Rotterdam, South Holland, 3118JH, Netherlands

RECRUITING

Related Publications (16)

• 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.

  PMID: 25441637 BACKGROUND

• 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.

  PMID: 29736895 BACKGROUND

• 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.

  PMID: 28651591 BACKGROUND

• 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.

  PMID: 36963417 BACKGROUND

• 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.

  PMID: 32060061 BACKGROUND

• 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.

  PMID: 33432682 BACKGROUND

• 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.

  PMID: 29339126 BACKGROUND

• 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.

  PMID: 27587317 BACKGROUND

• 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.

  PMID: 31568927 BACKGROUND

• 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.

  PMID: 34277075 BACKGROUND

• 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.

  PMID: 29928649 BACKGROUND

• 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.

  PMID: 28286157 BACKGROUND

• 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.

  PMID: 28288272 BACKGROUND

• 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.

  PMID: 35697450 BACKGROUND

• 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.

  PMID: 35933835 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Job FM van Boven, PharmD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Job FM van Boven, PharmD, PhD

CONTACT

+31 50 361 7893; j.f.m.van.boven@umcg.nl

Amber A Eikholt, MSc

CONTACT

+31 50 361 7860; a.a.eikholt@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 11, 2024
• Study Start: May 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-04

Locations

NL (5)