Adherium Smartinhaler Technology in New Multinational Study
5,700 Adherium Smartinhaler™ devices plus associated software and communications technologies to be supplied through to 2018
Study in New Zealand, Australia, the United Kingdom & Italy
Supply agreement with leading independent research institute, the Medical Research Institute of New Zealand
Adds to 31 clinical projects, 89,000 devices and AstraZeneca Supply & Development Agreement
Melbourne, Australia, 26 February 2016: Adherium Limited (ASX: ADR), a global leader in digital health technologies which address sub-optimal medication use in chronic disease, today confirmed the finalisation of a supply agreement with the Medical Research Institute of New Zealand (MRINZ), a leading independent medical research organisation, for the supply of 5,700 Smartinhaler™ devices and associated communications, software and support services for a major international clinical study.
The Smartinhaler™ platform will be supplied to MRINZ through to 2018 for use in the Novel START study, a “Randomised Controlled Trial of the efficacy and safety of an ICS/LABA reliever therapy regimen in Asthma (MRINZ/15/A1)”. MRINZ is the study sponsor and will initiate and co-ordinate the study, which will span New Zealand, Australia, the United Kingdom and Italy.
As part of the study MRINZ will monitor each randomised subject’s compliance and inhaler use. The Adherium Smartinhaler™ platform will be used to capture this data in an objective and accurate manner.
This study is the latest in a significant portfolio of clinical projects, which are supplied with medication use monitoring technology by Adherium. Currently the company is providing Smartinhaler™ devices, software and data management to 31 new clinical projects and programs around the world involving the deployment of more than 89,000 devices over the life of those projects.
“Clinical projects such as this major study being conducted by MRINZ are important to Adherium’s business,” said Adherium Group CEO Garth Sutherland.
“In addition to the revenue they provide, clinical projects such as this validate our ever-improving technology. They keep us engaged with leading respiratory Key Opinion Leaders and are an important demonstration of Adherium’s capabilities.”
“These represent important validation and sales and position the company strongly for its dual objectives to satisfy increasing demand from clinical trials and to lock in new large commercial agreements.”
In this study Adherium will be providing the Smartinhaler™ device, cloud services and access to medication use data via the Smartinhaler Live™ system, which allows for monitoring of large numbers of Smartinhaler™ devices being used in multiple countries concurrently. This will enable investigators at both site and sponsor level to monitor the medications used by trial patients and their adherence to the study protocol, providing important safety monitoring data and also key study outcome data.
“Our Smartinhaler™ platform has set the benchmark for accurate and objective monitoring of compliance and medication use in a clinical setting, and we are delighted to be supplying 5,700 devices and access to our software and communications technologies to this international study,” Sutherland commented.
Professor Richard Beasley of MRINZ commented, “The Adherium Smartinhaler™ platform allows us to monitor the patients with asthma in our clinical trial with a high degree of accuracy. This builds on our previous study published in the Lancet Respiratory Medicine, which investigated the efficacy and safety of novel asthma management regimens in high risk asthma. The objective data provided by the SmartinhalerLive™ system in that study enabled us to identify patterns of medication use with features such as medication overuse, delays in patients seeking medical review and long term medication exposure.’
“The ability for investigators to accurately monitor patients’ medication use and ensure that the study data is captured objectively and accurately is incredibly useful. The data collected in the Novel START study will be used as part of the primary outcome analysis to determine the optimal management regimen in mild asthma.”
The supply agreement will run for the duration of the study, which is expected to conclude in Q4 2018.
For more information about the Novel START Study please use the following links:
Study Summary including Study Sponsor and Participating Institutes: Australian & New Zealand Clinical Trials Registry https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369311
Paper in European Respiratory Society Journal entitled “Description of a randomised controlled trial of inhaled corticosteroid/fast-onset LABA reliever therapy in mild asthma” http://erj.ersjournals.com/content/early/2016/02/04/13993003.01692-2015?ctkey=ERJtw01692-2015)