The Medical Research Institute of New Zealand (MRINZ) has announced that it plans to launch an multi-country clinical study, called Novel START, using New Zealand-based Adherium’s connected inhalers. In addition to New Zealand, other study sites will be in Australia, the United Kingdom, and Italy.
Adherium's Smartinhaler sends data on when medication was taken to mobile devices and desktop computers via Bluetooth. The platform is designed to help patients, caregivers, and physicians remotely monitor and manage patients’ adherence to their medication. The devices have both a CE Mark and FDA 510(k) clearance.
Researchers plan to recruit 675 adults to investigate the safety and efficacy of three different treatment regimens for mild asthma. The first medication regimen uses a combination of inhaled corticosteroid (ICS) and long acting beta agonist (LABA), as needed. The second just uses short acting beta agonist (SABA) as needed. And the last regimen includes regular use of ICS and SABA as needed.
“The ability for investigators to accurately monitor patients’ medication use and ensure that the study data is captured objectively and accurately is incredibly useful,” MRINZ Director Richard Beasly said in a statement. “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.”
Adherium will supply MRINZ with 5,700 Smartinhaler devices as well as the associated communications, software, and support offerings, including Adherium’s Smartinhaler Live system that will help researchers monitor the large number of people using smart inhaler devices. Adherium will provide MRINZ with inhalers, through 2018, which is when the study, which will run for one year, is expected to conclude.
“Clinical projects such as this major study being conducted by MRINZ are important to Adherium’s business,” Adherium Group CEO Garth Sutherland said in a statement. “In addition to the revenue they provide, clinical projects such as this validate our ever-improving technology.”
In July 2015, Adherium partnered with AstraZeneca to incorporate digital health offerings into AstraZeneca’s patient support programs for people with COPD and asthma. A few months later, Adherium raised $25.6 million ($35 million AU) in an initial public offering on the Australian Securities Exchange, including a $3 million investment from AstraZeneca.
And in September, Adherium released data from three small studies of the company's Smartinhaler system. Data from the studies, all of which involved children and adolescents, indicate a 144 percent increase in adherence for patients using the connected devices, a 14.9 percent increase in lung function and a 37 percent reduction in oral steroid usage.