GSK and Propeller Health's smart inhaler aims to improve adherence in clinical trials
Using clip-on sensors developed by Propeller Health, the inhaler can track how often patients take their medication and provide insight on what may prevent utilization of the inhaler.
GlaxoSmithKline's plans to incorporate sensors in its inhalers is expected to provide real-time data about the patient experience in a clinical trial, and that may help improve adherence.
In November the FDA cleared GSK and Propeller Health to market a custom Propeller sensor with Ellipta, the drugmaker's COPD medication, for the treatment of asthma and COPD. GSK is now planning to launch a number of clinical trials for the Ellipta smart inhaler in early 2017.
The companies first announced the R&D collaboration in 2015.
“It's really the ability to tell whether someone is taking the medicine, to try to capture how patients feel, how active they are in the study,” said Ruth Tal-Singer, VP of clinical discovery in respiratory R&D and senior fellow at GSK. “We compare the treatment versus the control arm.”
Tal-Singer declined to provide details about the upcoming trials but said they will incorporate other technologies such as electronic diaries and sensors that monitor physical activity and vital signs to get a holistic picture of how a patient is doing in a clinical trial.
Several manufacturers of respiratory drugs have partnered with technology companies in an effort to improve outcomes and adherence rates. Teva Pharmaceutical Industries in 2015 acquired Gecko Health Innovations, which developed a cloud-based platform that relies on the cloud to remotely monitor chronic respiratory diseases and help manage them.
Analysts believe that technology solutions such as sensors could offer savings of approximately $19.3 billion for the 50 million people with asthma and chronic obstructive pulmonary disease in the United States alone, a 2015 Goldman Sachs report found.
Using clip-on sensors developed by Propeller Health, the inhaler can track how often patients take their medication and provide insight on what may prevent utilization of the inhaler. Every time a patient opens or closes the device, information about a patient's usage is sent via Bluetooth to GSK's clinical-trial database.
The sensor collects data about a patient's medication use that can be used to help improve their care, David Van Sickle, CEO of Propeller Health, said in a statement. “Propeller uses these data to deliver actionable reminders and insights to patients, with a focus on the patient experience, to improve self management, medication adherence, patient-clinician communication, and to improve the quality of ongoing care and treatment.”
With data imported in real-time to a database, patients do not need to make regular visits to a clinic to talk to a clinician about a medication and can participate in clinical trials remotely, said Tal-Singer.
“It really reduces the burden for all of them, specifically individuals who are very sensitive to the environment,” said Tal-Singer. “If it's a very cold day or there's a lot of pollution, it's difficult for someone with lung disease to come to the clinic. Instead of coming once a month or every two weeks, we can monitor how they are doing remotely.”
Remote monitoring also encourages patient participation in a clinical trial, which then allows researchers to get more accurate real-world data, said Tal-Singer. And the smart inhaler's ability to send information to a database in real-time reduces the burden of a clinician or the patient having to do it manually. This can also cut down on human error.
It's not the drugmaker's first time using sensor technology. GSK has used sensors to study mobility and activity in patients with rheumatoid arthritis and amyotrophic lateral sclerosis as well. Doing this helped the company gather more objective data than when it uses traditional methods such as written patient journals and walking tests at a physician's office.
“It really allows us to make a change, sometimes [make a] change in direction, where we see patients not adhering to something, to really understand why they didn't,” said Tal-Singer. “We need to hear the patient's voice and see how it works for them.”