Inhaler Device Research

Inhaler Device Research: research to aid the development of novel & innovative inhaler devices

Despite the existence of efficacious pharmacological agents for asthma, the clinical effectiveness of current inhaled therapies remains poor. The inhaler device steering group focuses on characterising the factors which explain the variability in asthma control, focusing on inhaler device as a key component of new developments to address uncontrolled asthma. The objective of the group is to undertake Systematic, Investigative and Experimental (“SIE”) research activities which:

  • Develop new knowledge regarding the factors which explain uncontrolled asthma and poor inhaler device technique
  • Inform the development of new novel inhaler devices and improve current inhaler devices deposition in the lung through novel tools

This research theme/project has been prioritised by a group of professionals in the asthma field as an area of scientific uncertainty that cannot be readily resolved by a competent professional, with novel features. The R&D requirements have been met as follows:

R&D Requirements
Objectives
  • To overcome the scientific challenge of developing new technologies and devices which improve asthma control for patients by understanding:
  • the specific inhaler device errors that are associated with poor asthma control by acquiring new knowledge that is not currently known of asthma patients and healthcare professionals.
  • identifying the inhaler device factors which result in poor adherence and safety concerns to inform novel inhaler devices development and improve current inhaler devices deposition in the lung through novel tools.
Novelty or technical risks This is deemed a novel project and the first of its kind in Singapore in relation to the creation or improvement of inhaler devices based on acquiring new knowledge.
SIE Studies/experiments  in field of science SIE studies are conducted to develop and test the creation or improvement of inhaler devices based on acquiring new knowledge on:

  • What are the inhaler device errors performed by patients which impact on asthma control?
  • What are the inhaler device errors performed by healthcare professionals which impact on the ability to effectively train patients?
  • What are the concerns regarding safety and adherence for patients with currently available inhaler device?

Research Activities (SIE Study)

The ongoing research activities of the inhaler device group include a series of planned activities to test or find out something that is not known or readily deducible in the field of uncontrolled asthma which will enable the group to develop new novel inhaler devices and improve current inhaler devices deposition in the lung through novel tools. The following SIE study activities identified by the group will provide outcomes that cannot be known or determined prior to the commencement of the study because the knowledge, information or experience to achieve the outcome is not reasonably available:

Activity 1 (CRITIKAL): What are the inhaler device errors performed by patients which impact on asthma control?
2014-2017

The CRITical Inhaler mistaKes and Asthma control (CRITIKAL) is an investigative SIE study investigating for the first time the association between specific inhaler device errors performed by patients and asthma control. The SIE study was proposed to inform the development of new novel inhaler devices and improve current inhaler devices deposition in the lung through novel tools. The study used unique data from iHARP asthma reviews. More than 5000 patients with asthma who were using either dry powder inhalers (DPI) or metered-dose inhalers (MDI).

This SIE study is the first in the world to identify the “critical” inhaler technique errors which were frequent and associated with poor asthma outcomes. Findings from this study were published in the Journal of Allergy and Clinical Immunology: In Practice (Impact factor: 7.0) and now inform the modification and re-design of new technologies and inhaler devices to address these issues.

Publications: CRITIKAL
David B. Price, et al. Inhaler errors in the CRITIKAL study: type, frequency, and association with asthma outcomes. J Allergy Clin Immunol Pract 2017; 5(4): 1071-81.e9.
[PubMed] [Full Text]

Activity 2 (HCP ELIOT) Investigating device mastery of healthcare professionals with a more intuitive, inhaler device model compared to an established device?
2014-2018

The Health Care Professional Easy Low Instruction Over Time (HCP ELIOT) is an experimental study investigating for the first-time health care professionals’ (HCPs’) use of a new inhaler device and identification of specific user requirements which are necessary to ensure that HCPs are able to demonstrate the correct technique with new devices to uncontrolled asthma patients. Knowledge from this project will inform the modification and potential re-design of the inhaler. This activity was investigative and experimental by using a new, more intuitive, inhaler device model compared to an established model.

A randomized, unblinded, crossover study was conducted involving 516 undergraduate HCPs. Participants underwent training in both inhaler devices, with each participants’ inhaler technique assessed after each training step by the clinical experts. Inhaler technique mastery was reassessed at 4 and 8 weeks since the initial training. Findings from this study were published in the Journal of Asthma (Impact factor: 2.08) and now inform the modification and re-design of new technologies and inhaler devices to address these issues.

Publications: HCP ELIOT
Sinthia Bosnic-Anticevich, et al. Inhaler technique mastery and maintenance in healthcare professionals trained on different devices. J Asthma 2018: 55(1): 79-88.
[PubMed] [Full Text]

Activity 3 (DASG) What are the inhaler device concerns regarding safety and adherence for patients with currently available inhaler device?
2015-2019

The Device Adherence Study Group is a SIE study investigating adherence and safety for all currently available inhaler devices. The SIE study will inform the development of new digital innovations to assess adherence within inhaler devices and identify areas of improvement for current inhaler devices regarding disposition of inhaled steroids to the lung. This activity will inform the modification and potential re-design of adherence technologies for the inhaler device.

Publications: DASG
Sinthia Bosnic-Anticevich, et al. The use of multiple respiratory inhalers requiring different inhalation techniques has an adverse effect on COPD outcomes. Int J Chron Obstruct Pulmon Dis 2017; 12: 59-71.
[PubMed] [Full Text]

Dekhuijzen PNR, et al. Incidence of oral thrush in patients with COPD prescribed inhaled corticosteroids: effect of drug, dose, and device.Respir Med 2016; 120: 54-63.
[PubMed] [Full Text]

Papi A,  et al. Relationship of inhaled corticosteroid adherence to asthma exacerbations in patients with moderate-to-severe asthma. J Allergy Clin Immunol Pract 2018; 6(6): 1989-1998.e3.
[PubMed] [Full Text]

Jaco Voorham, et al. Does co-payment for inhaler devices affect therapy adherence and disease outcomes? A historical, matched cohort study. Pragmat Obs Res 2017; 8: 31-41.
[PubMed] [Full Text]

Abstracts:
Comparative effectiveness of prescribing similarversusdissimilar inhalers for COPD therapy
Bosnic-Anticevich S, Chrystyn H, Costello R, Dolovich M, Fletcher M, et al.
J Thorac Dis 2016; 8(5): AB034. [Full Text]

The role of adherence to inhaled corticosteroids (ICS) in the relationship between blood eosinophilia and asthma control
Papi A, Ryan D, Soriano J, Chrystyn H, Price D, et al.
Eur Respir J2016; 48(Suppl 60): PA840. [Poster][Full Text]