REMOTELY RECORDED PEAK INHALATION FLOW PATTERNS AMONG PATIENTS WITH COPD USING PROAIR DIGIHALER FOR RESCUE MEDICATION

SESSION TITLE: Obstructive Lung Disease Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: A major challenge in the management of patients with COPD is insufficient objective information about rescue inhaler use in terms of frequency and technique. Sufficient peak inhalation flow (PIF) is required to overcome the specific internal resistance of a dry powder inhaler (DPI). Low PIF may result in inadequate deaggregation and dispersal of the drug, leading to changes in delivered dose and fine particle distribution. Information and feedback provided about inhalation variables could facilitate the identification of patients being at risk for deterioration of correct inhaler technique. The Digihaler is an electronic multi-dose DPI with integrated sensors capable of accurately measuring inhalation variables: PIF, inhalation volume, inhalation duration, and time to PIF. This analysis describes PIF for patients with COPD using ProAir Digihaler (albuterol 90 µg; 1 to 2 inhalations every 4 hours, as needed). METHODS: This 12-week, open-label study was conducted in patients (≥40 years) with COPD and ≥1 exacerbation in the previous year. Patients’ usual rescue medication was replaced with the Digihaler, which recorded timestamps and inhalation variables. At the end of the study, data were downloaded from the inhalers for analysis. RESULTS: Of the 405 patients enrolled, 359 generated at least 1 inhalation event. There were a total of 94,834 recorded events. Appropriate inhalations were stratified according to PIF (L/min) values (% of events): 30–44 (5.8 %); 45–59 (22.6 %); 60–119 (46.4 %); ≥120 (2.4 %). Incorrect use was identified by the detection of very low (PIF <18 L/min) or no inhalation flow (8.0 % of events), low inhalation flow (PIF 18–29 L/min, 0.2 %), and multiple inhalations recorded at one time, i.e. ≥1 inhalation before cap closure (13.8 %). For the inhalation events with PIF values within normal range for this specific device, the mean (SD) PIF was 66.3 (17.3) L/min, mean (SD) inhalation volume was 1.24 (0.61) L, mean (SD) time to PIF was 0.40 (0.25) seconds, and mean (SD) inhalation duration was 1.54 (0.71) seconds. Over the full study period, the average (SD) PIF grouped for all patients was 67.8 (19.3) L/min at Week 1 and 65.2 (16.9) L/min at Week 12. CONCLUSIONS: Data from this study demonstrates the ability of the Digihaler to capture objective inhaler data in patients with COPD. Throughout the study, patients were able to generate a PIF above 30 L/min in 77.2 % of inhalation events, while the most common errors were opening and closing the cap without a detectable inhalation and multiple inhalations without closing the cap. CLINICAL IMPLICATIONS: Data collected by Digihaler could potentially support remote patient monitoring and shared decision-making by providing objective inhaler usage data for a dialogue between patient and healthcare provider. The Digihaler system could, therefore, potentially be used as a tool to improve inhaler technique and, consequently, clinical outcomes. DISCLOSURES: Employee relationship with Teva Please note: >$100000 Added 06/04/2020 by Randall Brown, source=Web Response, value=Salary Employee relationship with Tevapharmaceuticals Please note: >$100000 Added 06/01/2020 by Michael De Pietro, source=Web Response, value=Salary No relevant relationships by Lena Granovsky, source=Web Response no disclosure on file for Thomas Li; Advisory Committee Member relationship with AstraZeneca Please note: $1001 - $5000 by Donald Mahler, source=Web Response, value=Honoraria Advisory Committee Member relationship with BoehringerIngelheim Please note: $1001 - $5000 by Donald Mahler, source=Web Response, value=Honoraria Advisory Committee Member relationship with GlaxoSmithKline Please note: $1001 - $5000 by Donald Mahler, source=Web Response, value=Honoraria Advisory Committee Member relationship with Sunovion Please note: $1001 - $5000 by Donald Mahler, source=Web Response, value=Honoraria Advisory Committee Member relationship with Theraance Please note: $1001 - $5000 by Donald Mahler, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with AstraZeneca Please note: $5001 - $20000 by Donald Mahler, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with BoehringerIngelheim Please note: $5001 - $20000 by Donald Mahler, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Sunovion Please note: $1001 - $5000 by Donald Mahler, source=Web Response, value=Honoraria royalties fees for baseline and transition dyspnea indexes relationship with Donald A. Mahler Please note: 1990 to present Added 06/01/2020 by Donald Mahler, source=Web Response, value=Royalty Consultant relationship with Donald A. Mahler Please note: 2000 to present Added 06/01/2020 by Donald Mahler, source=Web Response, value=Consulting fee speakers' bureau relationship with Donald A. Mahler Please note: 2000 to present Added 06/01/2020 by Donald Mahler, source=Web Response, value=Honoraria named lecturer relationship with Donald A. Mahler Please note: 2011 to present Added 06/01/2020 by Donald Mahler, source=Web Response, value=Honoraria Advisory Board relationship with Donald A. Mahler Please note: 2000 to present Added 06/01/2020 by Donald Mahler, source=Web Response, value=Honoraria named lecturer relationship with Boehringer Ingelheim Please note: Sept-October 2019 Added 06/01/2020 by Donald Mahler, source=Web Response, value=Honoraria Substantial Contributor relationship with Donald A. Mahler Please note: 2019 Added 06/01/2020 by Donald Mahler, source=Web Response, value=Honoraria speakers' bureau relationship with Boehringer Ingelheim Please note: 2018 to present Added 06/01/2020 by Donald Mahler, source=Web Response, value=Honoraria Advisory Board relationship with GlaxoSmithKline Please note: 2018 to present Added 06/01/2020 by Donald Mahler, source=Web Response, value=Honoraria speakers' bureau relationship with AstraZeneca Please note: 2018 to present Added 06/01/2020 by Donald Mahler, source=Web Response, value=Honoraria Advisory Board relationship with AstraZeneca Please note: 2017 to present Added 06/01/2020 by Donald Mahler, source=Web Response, value=Honoraria Advisory Board relationship with Sunovion Please note: 2017 to present Added 06/01/2020 by Donald Mahler, source=Web Response, value=Honoraria Advisory Board relationship with Theravance Please note: 2017 to present Added 06/01/2020 by Donald Mahler, source=Web Response, value=Honoraria Consultant relationship with Teva Please note: $1-$1000 Added 04/29/2020 by Roy Pleasants, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Boehringer Ingelheim Please note: $5001 - $20000 Added 04/29/2020 by Roy Pleasants, source=Web Response, value=Honoraria Advisory Committee Member relationship with Theravance Please note: $1-$1000 Added 04/29/2020 by Roy Pleasants, source=Web Response, value=Consulting fee No relevant relationships by Michael Reich, source=Web Response Employee relationship with Teva Pharmaceuticals Please note: >$100000 Added 06/01/2020 by Guilherme Safioti, source=Web Response, value=Salary No relevant relationships by Laurie Snyder, source=Web Response Employee relationship with TEVA Pharmaceuticals USA Inc Please note: >$100000 Added 06/01/2020 by Carlos Tafur, source=Web Response, value=Salary Removed 06/01/2020 by Carlos Tafur, source=Web Response Employee relationship with TEVA Pharmaceuticals USA Inc Please note: >$100000 Added 06/01/2020 by Carlos Tafur, source=Web Response, value=Salary