Ellipta Sensor Experience in COPD (ESSENCE)
Assessment of Patient Interaction with Ellipta Sensor and Integrated System Within the COPD Foundation Patient-Powered Research Network (ESSENCE)
The Ellipta Sensor Experience in COPD Study (ESSENCE) utilized the COPD Foundation research infrastructure to identify and recruit all of the study participants, collect study outcomes, and facilitate an asynchronous focus group. The ESSENCE study was an ancillary study to the COPD Patient-Powered Research Network (PPRN) which is a self-reported registry of over 8000 individuals with COPD or at risk for COPD. The online, asynchronous focus group was conducted utilizing a private feature on the COPD Foundation’s COPD360social online community.
Study results published
Funded by: GSK as an investigator-sponsored Study; GSK Study 210024
COPD Foundation Principal Investigator: Barbara Yawn, MD, MSc, MPH
Patient Investigator: John Linnell
In COPD studies, the use of electronic inhaler sensors to remotely monitor patient inhaler use demonstrated acceptable patient satisfaction and has been shown to decrease short-acting β2-agonist (SABA) use, increase medication adherence, and improve symptom control.1 Research assessing the patient-experience electronic inhaler sensors and the Ellipta inhaler devices in COPD was lacking.
This study aimed to determine the ability of individuals with COPD, using any COPD medication in an Ellipta inhaler, to install and use a sensor and engage with its associated app. In addition, the study aimed to gather adherence and rescue inhaler use patterns.
More specifically, the study assessed how often and how long participants engaged with the app associated with the electronic sensor, and whether the electronic inhaler sensors had any effect on Ellipta device medication adherence, rescue inhaler usage, rescue medication free days, and symptom control as measured by the COPD Assessment Test (CAT) scores and the COPD Treatment Ratio (CTR).
- Primary Objective: To evaluate the level of patient engagement, as measured by daily active use, with the mobile app associated with an Ellipta inhaler device medication sensor in a population of participants with COPD.
- Secondary Objective: To assess adherence data collected from Propeller Health clip-on sensor on Ellipta maintenance medications at 12-weeks and up to 24-weeks post-baseline
- To assess proportion of days and daily frequency of SABA use as well as rescue free days at 12-weeks and up to 24- weeks post-baseline
- To describe symptom control via CAT scores at 12-weeks and 24-weeks post-baseline
- To assess CTR at 12-weeks and up to 24-weeks-post baseline
- To assess patient insights and feedback on their experience with this technology
About the Study
A total of 122 participants were enrolled in (ESSENCE). All of these participants were identified through an online medication survey, developed by the COPD Foundation, and distributed and completed within the COPD Patient-Powered Research Network (PPRN). The survey collected information on all forms of COPD pharmacotherapy.
Respondents who reported an Ellipta medication on the medication survey (BREO, ANORO, INCRUSE, or TRELEGY), were invited to join the ESSENCE Study, if qualified. Other COPD PPRN participants and COPD Foundation community members were invited to join through different channels including the online community COPD360social and "Faces of COPD", the COPD Foundation’s newsletter. If interested, the community members registered and consented into the COPD PPRN to determine eligibility.
Completed Activities within the ESSENCE Study
- Pre-Screener: A pre-screener was made available on the COPD PPRN participant portal to assess the eligibility of interested individuals.
- Telephone Survey and Informed Consent: The purpose of the telephone screener was to confirm eligibility for those identified as potentially eligible in the ESSENCE Study online pre-screener. The informed consent (IC), compensation and details of the study, and information were conveyed about the sensor that attaches to the Ellipta inhaler device, the Propeller Health (PH) app along with ensuing steps to the enrollment process. Once the IC was signed, the PH access code was generated.
- Baseline Survey: After the IC was signed, the baseline survey was immediately available on the portal for completion. It asked questions about demographics, such as age, sex, and race as well questions about COPD medicines.
- Onboarding and Registration: Once a participant was consented and the baseline survey complete, the participant was able to access and download the PH app, as well as register online with PH where they were asked to answer additional questions about their COPD inhalers. An Ellipta inhaler device sensor and rescue inhaler sensor (if applicable) were shipped to the participant. Once the sensor was received, installed, and synched with the app, the study period and data collection began.
- 12-Week-Follow-Up Survey: After a participant had been using the Ellipta inhaler sensor and PH app for 12 weeks, a 12-week follow-up survey was available on their participant portal. This included the CAT test, along with a question asking if they would be interested in potentially participating in an online focus group at the end of the study.
- Exit Survey: At the end of the study period (12-24 weeks) the participant was able to complete the Exit survey on the participant portal. This survey gathered feedback on their experience with the PH app and sensor, along with the CAT.
- Focus Group: Participants for the online focus group were initially identified through the 12-week follow-up survey. Four participants from each activity level were selected to participate on the COPD360social platform in an asynchronistic focus group.
Results and Conclusions
Overall, the sensor and app were well received and used by this group of people with COPD. No impact on outcomes of interest such as lower COPD symptom burden, or better adherence to maintenance therapy were observed, possibly due in part to high initial medication adherence rates2 as well the short duration of the study and limited sample size. However, the increase in rescue-free days (days when no quick relief medication was used) was consistent with a previous finding in a larger asthma2 trial and may be a signal of benefit from the sensor and app. These results suggest that a larger trial should be completed in a population that is less initially adherent and may more clearly reflect maintenance therapy adherence in the general population of people with COPD.
Most importantly, the ESSENCE study demonstrated the COPD Foundation’s capability to recruit and operationalize a usability study for medical devices and digital health tools.
The results of the ESSENCE study were published in:
Yawn BP, McCreary GM, Linnell JA, et al. Pilot study of a patient experience with an ELLIPTA inhaler electronic medication monitor and associated integrated system: a prospective observational study using the COPD Patient-Powered Research Network. Chronic Obstr Pulm Dis. 2021; 8(4): 488-501. doi: https://doi.org/10.15326/jcopdf.2021.0218
To learn more about the study, contact firstname.lastname@example.org.
- 1. Attaway AH, Alshabani K, Bender B, Hatipoğlu US. The utility of electronic inhaler monitoring in COPD management: promises and challenges. Chest. 2020 Jun;157(6):1466-1477. doi: https://doi.org/10.1016/j.chest.2019.12.034.
- 2. Moore A, Preece A, Sharma R,et al. . A randomized controlled trial of the effect of a connected inhaler system on medication adherence in uncontrolled asthmatic patients. Eur Respir J. 2021 Jun 4;57(6):2003103. doi: https://doi.org/10.1183/13993003.03103-2020.