Background Inhaler technique errors are common in chronic obstructive pulmonary disease (COPD) treatment, potentially leading to poor disease management. Our pooled analysis approach assessed correct use and ease-of-use of a placebo ELLIPTA dry-powder inhaler (DPI) in patients with COPD. Methods Adults with COPD from open-label/non-blinded studies evaluating a placebo ELLIPTA DPI and reporting outcomes of correct use (based on the ELLIPTA DPI patient information leaflet [PIL]) and/or ease-of-use were included. Correct use and ease-of use at study end were primary and secondary endpoints, respectively. Data from patients in the placebo ELLIPTA DPI arm of each study were pooled, and the intent-to-treat (ITT) population was used for all analyses. Results Four placebo ELLIPTA DPI studies, reporting correct use (n = 4) and ease-of-use (n = 2), were included in the analysis. The ITT population comprised 1232 patients (mean age 66.2 years). For the primary endpoint, 80.1% (n = 975/1217) of patients demonstrated correct use at study end (95% confidence interval [CI]: 77.8%–82.3%). For the secondary endpoint, 95.7% (n = 797/833) of patients rated placebo ELLIPTA DPI use “easy”/“very easy” at study end (95% CI: 94.1%–97.0%). Correct use and “easy”/“very easy” user ratings remained high across younger (40–64 years) and older (≥65 years) age groups. Conclusions Across age groups, most patients used the placebo ELLIPTA DPI correctly and rated it “easy”/“very easy” to use. Consistent with the Global Initiative for Chronic Obstructive Lung Disease 2021 report, our findings emphasize that proper training and clear instructions on PILs are important for optimal inhaler use.

Background: Electronic medication monitors (EMMs) are associated with decreased rescue inhaler use, symptom burden, and increased medication adherence in asthma. However, the use of EMMs in people with chronic obstructive pulmonary disease (COPD) using the ELLIPTA dry powder inhaler has not been studied. Methods: This was an open-label, single-arm, prospective observational study of EMMs and associated application (app) use over 12 weeks and up to 24 weeks (April-October 2019) in people with self-reported COPD aged >= 40 years enrolled in the COPD Patient-Powered Research Network, using an ELLIPTA inhaler. The primary outcome was daily active use of the app over 12 weeks. Treatment adherence, rescue inhaler use, and participant satisfaction were assessed over the same period. Results: Among the 122 participants, mean (standard deviation [SD]) proportion of days participants opened the app was 59.5% (31.4), 51.1% (33.5) and 41.3% (34.2) for Days 1-30, 31-60 and 61-90, respectively. Mean (SD) adherence to maintenance medication remained stable: 80.2% (22.7) and 79.9% (26.7) for Days 1-30 and 61-90, respectively. In participants using a rescue inhaler and EMM, mean (SD) rescue-free days increased from 18.5 (10.0; Days 1-30, n=51) to 21.4 (9.6; Days 61-90, n=48). Participants reported high levels of confidence in using the EMM, valued app reminders highly, and reported high system satisfaction (mean [SD] scale: 1=low, 5=high; 4.6 [ 1.1], 4.3 [1.1] and 4.1 [1.1], respectively). Conclusions: Use of an ELLIPTA EMM with frequent app engagement, high participant satisfaction, and decreased rescue medication use may aid COPD management.

BACKGROUND:The influence of peak inspiratory flow (PIF) on dose delivery from dry powder inhalers (DPIs) and association with treatment efficacy in patients with chronic obstructive pulmonary disease (COPD) has not been fully determined. In vitro studies have demonstrated adequate dose delivery through ELLIPTA DPI at PIF ≥30 L/min. This analysis of two clinical trials and a real-world population of COPD patients determined spirometric PIF distribution, and explored the relationship between PIF and outcomes in the trials. METHODS:The replicate Phase IV, 12-week, randomized, double-blind 207608/207609 (NCT03478683/NCT03478696) trials evaluated fluticasone furoate/umeclidinium/vilanterol via ELLIPTA DPI versus budesonide/formoterol+tiotropium in COPD patients. This post hoc analysis assessed spirometric PIF distribution at screening and relationship between PIF and lung function outcomes in the pooled 207608/207609 population. Spirometric PIF distributions in a real-world population of COPD patients were evaluated by retrospective analysis of the Kaiser Permanente Northwest (KPNW) database to assess similarities between clinical trial and real-world populations. RESULTS:A total of 1460 (207608/207609) and 3282 (KPNW) patients were included. There was considerable overlap between spirometric PIF distributions for both populations. Overall, 99.7% and 99.8% of the 207608/207609 and KPNW populations, respectively, reported spirometric PIF ≥50 L/min, estimated as equivalent to ELLIPTA PIFR ≥30 L/min. In the 207608/207609 combined analysis, there was no significant interaction between spirometric PIF and treatment for lung function endpoints, indicating treatment effect is independent of PIF. CONCLUSION:Nearly all COPD patients in the 207608/207609 and KPNW populations achieved spirometric PIF values estimated as equivalent to PIFR of ≥30 L/min through the ELLIPTA DPI. Lack of correlation between spirometric PIF at screening and treatment efficacy aligns with consistent dose performance from the ELLIPTA DPI across a wide range of PIFs, achieved by patients with COPD of all severities.

Background Inhaler errors among patients with chronic obstructive pulmonary disease (COPD) can reduce treatment efficacy. Methods This randomized, open-label, crossover study evaluated correct use of ELLIPTA versus DISKUS plus HandiHaler. Participants with COPD attended at least 3 study visits (Day 1 [Visit 1], Day 28 [Visit 2], and Day 56 [Visit 3]). Inhalers contained placebo; usual maintenance medication was continued. Participants were randomized to an inhaler sequence (ELLIPTA then DISKUS plus HandiHaler, or the reverse) and preference questionnaire at Visit 1. Participants read the instructions for use in the approved prescribing information for their inhaler(s) and correct use was assessed at Visit 1 (verbal guidance provided if required). Correct use was reassessed at Visit 2, and with the next inhaler(s) at Visit 3. Primary endpoint was the proportion of participants demonstrating correct use (0 errors) with the assigned inhaler(s) after 28 days. Results A greater proportion of study participants (n = 217) correctly used ELLIPTA (96%) versus DISKUS plus HandiHaler (87%) after 28 days. The odds of demonstrating correct use with ELLIPTA were 6.88 times that of DISKUS plus HandiHaler (p < 0.001). Overall, > 99% of participants made 0 critical errors (errors leading to no or significantly reduced medication inhaled) with ELLIPTA versus 89% with DISKUS plus HandiHaler after 28 days. ELLIPTA was the patient-preferred option versus DISKUS plus HandiHaler or no preference (p < 0.001). Conclusions Delivery of COPD maintenance therapy via ELLIPTA demonstrates higher correct use rates and lower critical error rates compared with DISKUS plus HandiHaler.

Rationale Asthma studies show many children use inhalers incorrectly even after instruction. For two age groups of children with asthma, we determined the proportions who used the once-daily ELLIPTA dry-powder inhaler (DPI) correctly, and who found it easy to use. Methods This was a multicenter, single-arm, stratified, open-label, placebo study (NCT03478657). Children aged 5-7 and 8-11 years were trained in, and required to demonstrate, correct placebo ELLIPTA DPI use at their first clinic visit. The inhaler was used at home once daily for 28 +/- 2 days. On returning to the clinic, children were randomized to an age-appropriate, ease-of-use questionnaire that had been developed and validated previously, and which rated the inhaler as "easy" or "hard" to use. Following questionnaire completion, children were then asked to demonstrate correct inhaler use. Correct use and ease-of use were assessed in each age group (co-primary endpoints) and overall (secondary endpoints). Results Of 222 enrolled children, 221 completed the study. Among children aged 5-7 years, 92% (n = 81/88) demonstrated correct ELLIPTA use on their first attempt, compared with 93% (n = 124/133) aged 8-11 years. Of these children, 98% (5-7 years: n = 79/81; 8-11 years: n = 121/124) rated the inhaler easy to use. Overall, 93% (n = 205/221) demonstrated correct inhaler use on their first attempt, and 98% (n = 200/205) rated it easy to use. Conclusion ELLIPTA DPI was used correctly and easily by most children on their first attempt without additional training.

David J Collier 1,2 Pascal Wielders Job van der Palen 4,5 Logan Heyes 6 Dawn Midwinter 6 Kathryn Collison 7 Andy Preece 6 Neil Barnes 1,6 Raj Sharma 1William Harvey Research Institute, Barts & The London School of Medicine &Dentistry, Queen Mary University of London, London, UK; 2Wolfson Institute of Preventive Medicine, Barts & The London School of Medicine & Dentistry, Queen Mary University of London, London, UK; 3Department of Pulmonary Diseases, CatharinaHospital, Eindhoven, Netherlands; 4Department of Pulmonology, Medisch Spectrum Twente, Enschede, Netherlands; 5Department of Research Methodology, Measurement, and Data Analysis, University of Twente, Enschede, Netherlands; 6Respiratory Therapy Area Unit, GlaxoSmithKline Plc., Stockley Park, Uxbridge, UK; 7Respiratory Medical Franchise, GlaxoSmithKline Plc., Research Triangle Park, Durham, NC, USA Introduction: Training in correct inhaler use, ideally in person or by video demonstration, can minimize errors but is rarely provided in clinics. This open-label, low-intervention study evaluated critical error rates with dry-powder inhalers (DPIs), before and after training, in patients with chronic obstructive pulmonary disease. Methods: Patients prescribed an inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) (ELLIPTA, Turbuhaler, or DISKUS), long-acting muscarinic antagonist (LAMA)/ LABA (ELLIPTA or Breezhaler), or LAMA-only DPI (ELLIPTA, HandiHaler, or Breezhaler) were enrolled. Critical errors were assessed before training (Visit 1 [V1]; primary endpoint) and 6 weeks thereafter (Visit 2 [V2]; secondary endpoint). Logistic regression models were used to calculate odds ratios (ORs) for between-group comparisons. Results: The intent-to-treat population comprised 450 patients. At V1, fewer patients made ≥1 critical error with ELLIPTA (10%) versus other ICS/LABA DPIs (Turbuhaler: 40%, OR 4.66, P=0.005; DISKUS: 26%, OR 2.48, P=0.114) and other LAMA or LAMA/LABA DPIs (HandiHaler: 34%, OR 3.50, P=0.026; Breezhaler: 33%, OR 3.94, P=0.012). Critical error rates with the primary ICS/LABA DPI were not significantly different between ELLIPTA ICS/LABA (10%) and ICS/LABA plus LAMA groups (12–25%). Critical errors with the primary ICS/LABA DPI occurred less frequently with ELLIPTA ICS/LABA with or without LAMA (11%) versus Turbuhaler ICS/LABAwith or without LAMA (39%, OR 3.99, P<0.001) and DISKUS ICS/LABAwith or without LAMA (26%, OR 2.18, P=0.069). Simulating singleinhaler versus multiple-inhaler triple therapy, critical error rates were lower with ELLIPTA fluticasone furoate/vilanterol (FF/VI; 10%) versus ELLIPTA FF/VI plus LAMA (22%), considering errors with either DPI (OR 2.50, P=0.108). At V2, critical error rates decreased for all DPIs/groups, reaching zero only for ELLIPTA. Between-group comparisons were similar to V1. Conclusion: Fewer patients made critical errors with ELLIPTA versus other ICS/LABA, and LAMA or LAMA/LABA DPIs. The effect of “verbal” training highlights its importance for reducing critical errors with common DPIs.

Introduction: Training in correct inhaler use, ideally in person or by video demonstration, can minimize errors but is rarely provided in clinics. This open-label, low-intervention study evaluated critical error rates with dry-powder inhalers (DPIs), before and after training, in patients with chronic obstructive pulmonary disease. Methods: Patients prescribed an inhaled corticosteroid (ICS)/long-acting beta(2)-agonist (LABA) (ELLIPTA, Turbuhaler, or DISKUS), long-acting muscarinic antagonist (LAMA)/ LABA (ELLIPTA or Breezhaler), or LAMA-only DPI (ELLIPTA, HandiHaler, or Breezhaler) were enrolled. Critical errors were assessed before training (Visit 1 [V1]; primary endpoint) and 6 weeks thereafter (Visit 2 [V2]; secondary endpoint). Logistic regression models were used to calculate odds ratios (ORs) for between-group comparisons. Results: The intent-to-treat population comprised 450 patients. At V1, fewer patients made >= 1 critical error with ELLIPTA (10%) versus other ICS/LABA DPIs (Turbuhaler: 40%, OR 4.66, P=0.005; DISKUS: 26%, OR 2.48, P=0.114) and other LAMA or LAMA/LABA DPIs (HandiHaler: 34%, OR 3.50, P=0.026; Breezhaler: 33%, OR 3.94, P=0.012). Critical error rates with the primary ICS/LABA DPI were not significantly different between ELLIPTA ICS/LABA (10%) and ICS/LABA plus LAMA groups (12-25%). Critical errors with the primary ICS/LABA DPI occurred less frequently with ELLIPTA ICS/LABA with or without LAMA (11%) versus Turbuhaler ICS/LABAwith or without LAMA (39%, OR 3.99, P<0.001) and DISKUS ICS/LABAwith or without LAMA (26%, OR 2.18, P=0.069). Simulating singleinhaler versus multiple-inhaler triple therapy, critical error rates were lower with ELLIPTA fluticasone furoate/vilanterol (FF/VI; 10%) versus ELLIPTA FF/VI plus LAMA (22%), considering errors with either DPI (OR 2.50, P=0.108). At V2, critical error rates decreased for all DPIs/groups, reaching zero only for ELLIPTA. Between-group comparisons were similar to V1. Conclusion: Fewer patients made critical errors with ELLIPTA versus other ICS/LABA, and LAMA or LAMA/LABA DPIs. The effect of "verbal" training highlights its importance for reducing critical errors with common DPIs.

Pediatric asthma studies indicate that many children demonstrate incorrect inhaler use even after instruction. We aimed to evaluate the proportions of children with asthma, in two age groups, who correctly used the once-daily Ellipta dry powder inhaler (DPI), and who found the Ellipta DPI easy to use. Multicenter, single-arm, stratified, open-label, randomized, placebo study. Children (5–7 and 8–11 years of age), continuing their usual inhaled asthma medication, were trained in, and required to demonstrate, correct placebo Ellipta DPI use at their first clinic visit. The Ellipta DPI was used once daily for 28±2 days at home. Returning to the clinic, children were randomized to an ease-of-use questionnaire, and rated Ellipta DPI use as "easy" or "hard". After questionnaire completion, children were asked to demonstrate correct DPI use. Correct use and ease-of use were assessed in each age stratum (co-primary endpoints) and for all participants (secondary endpoint). Of 222 enrolled participants, one withdrew and 221 returned to the clinic. 92% of 5–7 year olds (n=81/88) and 93% of 8–11 year olds (n=124/133) demonstrated correct Ellipta DPI use on their first attempt (overall, 93% [n=205/221]), with 98% of these children (5–7 year-olds [n=79/81]; 8–11 year-olds [n=121/124]; overall [n=200/205]) rating the DPI as "easy" to use. Most children were able to use the once-daily Ellipta DPI correctly and easily, suggesting that the Ellipta DPI may simplify inhaler use for children with asthma in clinical practice.

SESSION TITLE: Obstructive Lung Disease Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: Electronic medication monitors (EMM) and linked apps remotely monitor patient (pt) inhaler use, providing information on time of next dose, tracking inhaler use and symptom relevant factors (eg air quality). In asthma, EMMs have been associated with increased medication adherence, decreased rescue therapy use and symptom burden; however, few studies have included pts with chronic obstructive pulmonary disease (COPD) or using dry powder inhalers (DPI). METHODS: This open-label, single-arm, prospective observational cohort study recruited pts from the COPD Foundation’s Patient Powered Research Network (April–July 2019). Members were invited to participate if: aged ≥40 years, they used DPI maintenance therapy for COPD (self-reported) and had a compatible smartphone. Pts were excluded if enrolled in a COPD clinical study or reported off-label DPI use. After informed consent, pts received a controller inhaler EMM, rescue inhaler EMM (if requested), and downloaded the linked app. Pts completed a baseline questionnaire. Index date was at first connection of EMM to the app. Pts were followed for a minimum of 12 weeks up to 24 weeks to observe inhaler use and daily app interaction frequency. DPI maintenance treatment adherence was quantified as days therapy used as prescribed. Rescue medication use was quantified by puffs among pts with a rescue inhaler EMM. Pts completed questionnaires at 12 and 24 weeks (or study exit, if earlier). At baseline, pts completed the COPD Assessment Test and self-reported exacerbations in the prior year to determine Global initiative for Chronic Obstructive Lung Disease (GOLD) stage. RESULTS: Overall, 122 pts were enrolled. At baseline, most pts were ≥65 years (53.3%), female (63.9%), white non-Hispanic (95.1%), GOLD Stage B (51.6%) or D (43.4%). Overall, 9.0% of pts were current smokers, 5.7% had COPD for <1 year, 30.3% had concurrent asthma. The mean proportion of days (standard deviation [SD]) pts interacted with the app decreased over time from 59.5% (31.4) to 51.1% (33.5) and 41.3% (34.3) in days 1–30, 31–60 and 61–90, respectively. Mean DPI actuations (proportion of days [SD]) remained constant from days 1–30 (79.0% [23.7]) vs days 61–90 (79.5% [27.3]). In pts with a rescue EMM, mean rescue-free days (SD) increased from 18.5 (8.9 [days 1–30, n=51]) to 21.4 (9.6 [days 61–90, n=48]). Pts expressed (mean score out of 5, where the scale was 1 low–5 high, [SD]): confidence in EMM use (4.6 [1.1]), value from app reminders (4.3 [1.1]) and system satisfaction (4.1 [1.1]). CONCLUSIONS: Pts in a COPD cohort were satisfied using the EMM and associated app. Interaction with the app decreased over time. Pts also had high and consistent EMM adherence to DPI use and among pts with a rescue EMM, the number of rescue-free days increased. CLINICAL IMPLICATIONS: In this study, EMM use was associated with high pt satisfaction and frequent engagement with the app, which may aid COPD management. DISCLOSURES: No relevant relationships by Radmila Choate, source=Web Response Employee relationship with GlaxoSmithKline Please note: >$100000 Added 04/16/2020 by Kathryn Collison, source=Web Response, value=Salary Employee relationship with GlaxoSmithKline Please note: $20001 - $100000 Added 04/16/2020 by Kathryn Collison, source=Web Response, value=shares Employee relationship with ResMed (of which Propeller Health is an affiliate) Please note: >$100000 Added 04/16/2020 by Rahul Gondalia, source=Web Response, value=Salary No relevant relationships by Daniel Gratie, source=Web Response Employee relationship with ResMed Please note: >$100000 Added 04/16/2020 by Leanne Kaye, source=Web Response, value=Salary Patient Advisory Panel relationship with AstraZeneca Please note: $1-$1000 Added 04/16/2020 by John Linnell, source=Web Response, value=Consulting fee Advisory Committee Member relationship with GSK Please note: $1-$1000 Added 04/16/2020 by John Linnell, source=Web Response, value=Consulting fee No relevant relationships by Elisha Malanga, source=Web Response No relevant relationships by Gretchen McCreary, source=Web Response No relevant relationships by Cara Pasquale, source=Web Response Own stock relationship with GlaxoSmithKline Please note: $1-$1000 Added 04/16/2020 by Richard Stanford, source=Web Response, value=t Employee relationship with Propeller Health Please note: >$100000 Added 04/16/2020 by David Stempel, source=Web Response, value=Salary Former employee relationship with GlaxoSmithKline Please note: $5001 - $20000 Added 04/16/2020 by David Stempel, source=Web Response, value=Stockholder Employee relationship with GSK Please note: >$100000 Added 04/16/2020 by Ryan Tomlinson, source=Web Response, value=Salary No relevant relationships by Benjamin Wu, source=Web Response Consultant relationship with GSK Please note: $5001 - $20000 Added 03/02/2020 by Barbara Yawn, source=Web Response, value=Consulting fee Advisory Committee Member relationship with BI Please note: $1001 - $5000 Added 03/02/2020 by Barbara Yawn, source=Web Response, value=Honoraria Advisory Committee Member relationship with AZ Please note: $1001 - $5000 Added 03/02/2020 by Barbara Yawn, source=Web Response, value=Honoraria Advisory Committee Member relationship with Sunovian Please note: $1001 - $5000 Added 03/02/2020 by Barbara Yawn, source=Web Response, value=Honoraria

SESSION TITLE: Tuesday Electronic Posters 4 SESSION TYPE: Original Inv Poster Discussion PRESENTED ON: 10/22/2019 01:00 PM - 02:00 PM PURPOSE: Inhalers should be easy to operate correctly to ensure effective delivery of inhaled medications. Since an inadequate technique has the potential to reduce the effects of medication, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively is important. The ELLIPTA inhaler is a dry powder inhaler that has been developed for the delivery of a range of inhaled medications. Because of the known problems with incorrect technique with some inhalers, it is important to demonstrate that patients can correctly use the ELLIPTA inhaler and find it easy to use. METHODS: This meta-analysis study was designed to assess the proportion of subjects with COPD who demonstrate correct use of the ELLIPTA inhaler (ELLIPTA is a trade mark owned by or licensed to the GSK group of companies) and to determine the proportion of subjects who rate the use of the ELLIPTA inhaler as easy or very easy to use at the end of the study. The meta-analysis inclusion criteria were open-label placebo ELLIPTA inhaler studies in patients with COPD with a reported outcome of correct use and/or ease of use. Non-placebo studies, reviews and conference abstracts were excluded. The Intent-to-Treat Population was used for all study population and safety analyses. There are no treatment comparisons in this meta-analysis. Four studies met the criteria for inclusion into this meta-analysis: GSK study 200301/NCT02184624; GSK study 201701/NCT02586493; GSK study 206215/NCT02982187 and GSK206901/NCT03227445. RESULTS: 1232 COPD patients were included: median age 66.2 years, 43% female. At study end, 80.1% demonstrated correct inhaler use. Analysis of correct use by age groups of 40-64 (n=478 correct use 85.1%); 65-74 (n=550; correct use of 77.6%) and ≥75 years old (n=189; correct use of 74.6%) indicated consistent correct use with increasing age of patients. Of the 4 studies, 2 assessed ease of use (n=833). 95.7% rated the inhaler as ‘easy’ or ’very easy’ to use with very little difference by age groups. AE rates were 6%; the most frequent AE was headache (<1%). Seven patients reported eight treatment-related AEs (cough, n=4; dyspnea, n=1; oral paresthesia, n=1; laceration, n=1; back pain, n=1). CONCLUSIONS: The ELLIPTA inhaler was operated correctly and rated ‘easy’ or ‘very easy’ to use by the majority of COPD patients irrespective of age group. CLINICAL IMPLICATIONS: The clinical implications of this meta-analysis is a successful demonstration of correct use of the ELLIPTA device by a majority of COPD patients enrolled in these trials. It was also rated as "easy" or "very easy" to use in a subset of these trials. When the correct use data was analyzed across age groups, there was consistent correct use by all age groups. DISCLOSURES: Employee relationship with GSK Please note: >$100000 Added 01/29/2019 by Lee Baylis, source=Web Response, value=Salary Employee relationship with GlaxoSmithKline Please note: >$100000 Added 01/30/2019 by Kathryn Collison, source=Web Response, value=Salary Employee relationship with GlaxoSMithKline Please note: $20001 - $100000 Added 01/30/2019 by Kathryn Collison, source=Web Response, value=Shares Employee relationship with GSK Please note: >$100000 Added 01/29/2019 by Renu Jain, source=Web Response, value=Salary No relevant relationships by Pinal Patel, source=Web Response Employee relationship with Glaxosmithkline Please note: $20001 - $100000 Added 02/07/2019 by raj sharma, source=Web Response, value=Salary Employee relationship with GlaxoSmithKline Please note: >$100000 Added 01/29/2019 by Laura Sutton, source=Web Response, value=Salary

BACKGROUND: Reduced error rates have been demonstrated with the ELLIPTA inhaler versus other commonly used devices. OBJECTIVE: This phase IV, randomized, crossover study evaluated correct use of ELLIPTA compared with 2 commonly prescribed metered-dose inhalers (MDIs) in adults with asthma and optimized inhaler technique. METHODS: The study comprised 2 crossover substudies (ELLIPTA vs MDI-1 and ELLIPTA vs MDI-2). Inhaler use was assessed at the start of each period, following instruction from a health care professional, and after 28 days of use without instruction. Data for each inhaler were pooled within substudies, irrespective of treatment sequence; study objectives were addressed in each substudy. The primary end point, percentage of participants making 0 errors after 28 days of use, was analyzed separately for each substudy using a Mainland-Gart test for each ELLIPTA versus MDI comparison. RESULTS: Correct use rates after 28 days were higher with ELLIPTA than with MDI-1 and MDI-2 (ELLIPTA vs MDI-1, 96% vs 84%; ELLIPTA vs MDI-2, 98% vs 91%). Among discordant cases, statistically significantly more participants correctly used ELLIPTA but made 1 or more overall error with MDIs than did those who correctly used the MDIs but made 1 or more overall error using ELLIPTA (87% vs 13% in both substudies; P < .001 and P = .007 for ELLIPTA vs MDI-1 and ELLIPTA vs MDI-2, respectively). More participants made multiple device errors with MDIs than with ELLIPTA. CONCLUSIONS: Inhaler technique can be optimized in trial settings. In such settings, ELLIPTA is associated with higher rates of correct use and lower error rates than are MDIs. (C) 2019 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology.

This randomised, open-label, cross-over, placebo-containing inhaler study assessed patient preference indicators for ELLIPTA and HandiHaler dry powder inhalers in patients with COPD (NCT02786927; GSK identifier: 204983). The primary objective of this study was to assess patient preference between ELLIPTA and HandiHaler based on the number of steps needed to use the inhaler. Eligible patients >= 40 years of age with COPD were randomised 1:1 to receive their current COPD medication plus a placebo-containing ELLIPTA or HandiHaler inhaler once daily for 7 +/- 2 days (treatment period 1); this was followed by a 7 +/- 2-day placebo treatment with the alternative inhaler. A 5-item questionnaire assessed inhaler-related patient preferences. A total of 212 patients (mean age, 65.1 years) were enrolled at 22 US sites; 73% had a COPD duration >= 5 years. Median (range) exposure was 8 (5, 13) days for ELLIPTA and 8 (1, 16) days for HandiHaler. Significantly more patients preferred ELLIPTA to HandiHaler in terms of the number of steps to use and all secondary attributes (size, comfort of the mouthpiece, remaining doses, and ease of use of the two inhalers; all p < 0.001). Similar results were observed irrespective of the order of inhaler use. Eighteen patients (8%) reported at least one AE and two (<1%) patients reported four non-fatal SAEs; none were related to the study treatment. Patient attitude toward a particular inhaler and their experiences in using it can affect adherence to therapy, which can in turn strongly influence effectiveness of inhaled medications. This study uses a robust methodology to assess patient preference.

Correct use and ease of use of a placebo dry powder inhaler was evaluated in two single-arm, United States-multicenter, phase-IV studies in adults with asthma ( n = 259) or chronic obstructive pulmonary disease (COPD; n = 278) who were receiving maintenance inhaler therapy. Subjects demonstrating correct placebo inhaler use within three attempts at screening were instructed to take once-daily inhalations from the inhaler for 28 ± 2 days (continuing usual maintenance), followed by randomization to complete one of two versions of an ease-of-use questionnaire and reassessment for correct inhaler use. At study end, 96% asthma/93% COPD subjects rated the placebo inhaler as “easy” or “very easy” to use while demonstrating correct use. Furthermore, 99% asthma/99% COPD subjects indicated it was “easy” or “very easy” to determine number of doses remaining, and 81%/84%, respectively, indicated they would be “likely” or “very likely” to request their current medication in the inhaler, if available. Adverse event (AE) rates were 12% asthma/15% COPD, most frequently headache (3%/3%). Treatment-related AEs were reported in one subject with asthma (cough) and four subjects with COPD (cough, n = 3; back pain, n = 1). At study end, most subjects with asthma or COPD operated the placebo inhaler correctly and found it easy to use.

Background: There is no consensus on how to define patients with symptoms of asthma and chronic obstructive pulmonary disease (COPD). A diagnosis of asthma-COPD overlap (ACO) syndrome has been proposed, but its value is debated. This study (GSK Study 201703 [NCT02302417]) investigated the ability of statistical modeling approaches to define distinct disease groups in patients with obstructive lung disease (OLD) using medical history and spirometric data. Methods: Patients aged >18 years with diagnoses of asthma and/or COPD were categorized into three groups: 1) asthma (nonobstructive; reversible), 2) ACO (obstructive; reversible), and 3) COPD (obstructive; nonreversible). Obstruction was defined as a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity <0.7, and reversibility as a post-albuterol increase in FEV1 >= 200 mL and >= 12%. A primary model (PM), based on patients' responses to a health care practitioner-administered questionnaire, was developed using multinomial logistic regression modeling. Other multivariate statistical analysis models for identifying asthma and COPD as distinct entities were developed and assessed using receiver operating characteristic (ROC) analysis. Partial least squares discriminant analysis (PLS-DA) assessed the degree of overlap between groups. Results: The PM predicted spirometric classifications with modest sensitivity. Other analysis models performed with high discrimination (area under the ROC curve: asthma model, 0.94; COPD model, 0.87). PLS-DA identified distinct phenotypic groups corresponding to asthma and COPD. Conclusion: Within the OLD spectrum, patients with asthma or COPD can be identified as two distinct groups with a high degree of precision. Patients outside these classifications do not constitute a homogeneous group.

SESSION TITLE: Obstructive Lung Diseases 1 SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/10/2018 01:00 PM - 02:00 PM PURPOSE: Inhalers should be easy to operate correctly to ensure effective delivery of inhaled medications. Two multi center, single-arm, placebo, Ph IV studies were conducted to evaluate ease and correct use of the ELLIPTA inhaler in adults with asthma (GSK study 201594/NCT02586506) or COPD (GSK study 201071/NCT02586493). METHODS: Asthma & COPD pts receiving maintenance therapy, but no prior/ongoing use of an ELLIPTA inhaler (w/i 6 months for COPD), were eligible. Pts demonstrating correct inhaler use within 3 attempts were instructed to take once-daily inhalations from a placebo ELLIPTA inhaler for 28±2 days, while continuing usual therapy. Easy to use was defined as a rating of ‘easy’ or ‘very easy’ on a 4-point scale (very easy, easy, difficult, very difficult) and was only assessed for pts who demonstrated correct use of the study inhaler on the 1st attempt as assessed by the inhaler-trained HCP. At study end, pts were randomized 1:1 to complete 1 of 2 versions of an ease-of-use questionnaire (differing response order) and were re-assessed for correct use. RESULTS: 259 asthma and 278 COPD pts were enrolled; 250 asthma and 267 COPD pts were included in the modified intent to treat (mITT) population for analyses*†. Overall, 96% of asthma pts and 93% of COPD pts rated the inhaler as ‘easy’ or ’very easy’ to use and demonstrated correct inhaler use. A post-hoc analysis by age group was conducted for both studies. In the asthma study, 94% of pts in the 18-44yrs group (n=98) reported ELLIPTA as ‘easy’ or ‘very easy’ to use and demonstrated correct inhaler use; 97% of the pts in the 45-64yrs group (n=116) and 97% of pts in the ≥65yrs (n=36) group also reported the same. Similarly, in the COPD study, 95% of pts in the 40-64yrs group (n=129) reported ELLIPTA as ‘easy’ or ‘very easy’ to use; 90% in the 65-74yrs group (n=105) and 100% in the ≥75yrs group (n=33) also reported the same. AE rates were 12% and 15% in the asthma and COPD studies, respectively; the most frequent AE was headache (3% in both). [*mITT population=all pts who were screened (Visit 1), who received ≥1 dose of placebo study treatment, and who were randomized to receive the ease-of-use questionnaire at study end (Visit 2). In both studies, the mITT population was used for analysis of the pre-specified primary and secondary endpoints. †One pt in the COPD mITT population was randomized in error and did not complete the ease-of-use questionnaire.] CONCLUSIONS: The ELLIPTA was operated correctly and rated ‘easy’ or ‘very easy’ to use by the majority of pts with asthma and COPD. Correct use and ease of use was similar across all age groups, including those ≥65 years in both asthma and COPD as well as those ≥75 years for COPD. CLINICAL IMPLICATIONS: Inhaler ease of use is important when selecting asthma and COPD treatments and may improve treatment compliance. Regardless of age, ≥90% of pts with asthma or COPD rated ELLIPTA as easy to use. Funded by GSK DISCLOSURES: Employee relationship with GlaxoSmithKline Pharmaceuticals Please note: >$100000 Added 02/28/2018 by Lee Baylis, source=Web Response, value=Salary Owner of shares relationship with GlaxoSmithKline Please note: >$100000 Added 02/28/2018 by Kathryn Collison, source=Web Response, value=Shares Removed 02/28/2018 by Kathryn Collison, source=Web Response Employee relationship with GlaxoSmithKline Please note: >$100000 Added 02/28/2018 by Kathryn Collison, source=Web Response, value=Salary Owner of shares relationship with GlaxoSmitjKline Please note: $20001 - $100000 Added 02/28/2018 by Kathryn Collison, source=Web Response, value=Share Employee relationship with GSK Please note: >$100000 Added 02/28/2018 by Renu Jain, source=Web Response, value=Salary Employee relationship with GlaxoSmithKline Please note: >$100000 Added 02/28/2018 by David Mannino, source=Web Response, value=Salary Employee relationship with GlaxoSmithKline Please note: $20001 - $100000 Added 02/28/2018 by David Mannino, source=Web Response, value=Ownership interest No relevant relationships by Pinal Patel, source=Web Response Employee relationship with GlaxoSmithKline Please note: >$100000 Added 02/06/2018 by Laura Sutton, source=Web Response, value=Salary

SESSION TITLE: COPD 2 SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, November 1, 2017 at 01:30 PM - 02:30 PM PURPOSE: Most maintenance treatments in the United States (US) for chronic obstructive pulmonary disease (COPD) are delivered using inhaler technology. This study compares patient preference of inhaler-specific attributes and overall preference for two existing dry powder inhalers: HandiHaler and ELLIPTA. The inhaler attributes evaluated have previously been assessed for importance by patients. METHODS: This is a multicenter (US), randomized, open-label, crossover study. Patients with COPD who have not used ELLIPTA or HandiHaler within 6 months from screening were randomized to ELLIPTA placebo once-daily or HandiHaler placebo once-daily followed by HandiHaler or ELLIPTA placebo respectively, for approximately one week for each treatment period. At study end, patients answered 4 questions evaluating their preference of inhaler attributes and one overall preference question. The primary endpoint was preference based on number of steps to receive medication. The secondary endpoints were subject's preference based on ease of assessing remaining doses and inhaler size. Other endpoints evaluated were preference based on mouthpiece comfort and overall inhaler preference. Responses were analyzed using a Cochran-Mantel-Haenszel test and adjusted for inhaler use sequence and preference questionnaire version (ELLIPTA and HandiHaler presented in vice-versa order in 2 versions). The primary preference measure had to achieve statistical significance at α=0.05 level to make statistical inference for the secondary measures. Secondary measures were subject to multiplicity adjustment using Hochberg's method. Safety assessments included adverse events (AEs) and exacerbations. RESULTS: A total of 227 subjects were screened, with 214 enrolled and included in the Intent-to-Treat population for safety assessment. Of these, 208 subjects completed at least one preference question and were included in the Modified Intent-To-Treat population. For the primary endpoint, inhaler preference assessed based on the number of steps needed to take the COPD medication was significantly higher (p<0.001) for the ELLIPTA inhaler (151 subjects [73%]) compared with the HandiHaler inhaler (42 subjects [20%]); 15 subjects [7%] had no preference. Overall, COPD subjects preferred ELLIPTA to HandiHaler for number of steps to receive medication and all other attributes tested, as well as overall inhaler preference (p<0.001, all comparisons). AEs were reported in 18 subjects. Two subjects experienced non-fatal serious AEs. Four subjects reported exacerbations. CONCLUSIONS: Significantly more COPD patients preferred ELLIPTA compared with HandiHaler for number of steps needed to take medication, ease of assessing remaining doses, inhaler size and mouthpiece comfort. For overall inhaler preference, significantly more COPD patients preferred ELLIPTA than HandiHaler. Safety in subjects using both placebo inhalers was consistent with health conditions observed in patients with COPD in general. CLINICAL IMPLICATIONS: Patient inhaler preference is important when selecting COPD treatment as preference for a particular inhaler may improve treatment compliance. For overall inhaler preference, significantly more patients preferred ELLIPTA than HandiHaler. DISCLOSURE: Kathryn Collison: Employee: GSK, Shareholder: GSK Pinal Patel: Employee: GSK, Shareholder: GSK Andrew Preece: Employee: GSK, Shareholder: GSK Richard Stanford: Employee: GSK, Shareholder: GSK Raj Sharma: Employee: GSK, Shareholder: GSK The following authors have nothing to disclose: Gregory Feldman No Product/Research Disclosure Information

Introduction.: The long-acting muscarinic antagonist, umeclidinium (UMEC), combined with the inhaled corticosteroid, fluticasone furoate (FF), improves lung function in symptomatic patients with asthma. We assessed FF/UMEC in patients with a primary diagnosis of asthma,or chronic obstructive pulmonary disease (COPD), but physiological characteristics of both (fixed airflow obstruction and reversibility to salbutamol). Methods: This double-blind, parallel-arm, 3-phase study randomised 338 patients (1:1:1:1:2:2) to FF 100 mcg alone or combined with UMEC (15.6, 62.5,125, or 250 mcg) or vilanterol 25 mcg (Phase A, 4 weeks). Primary endpoint: change from baseline in clinic trough forced expiratory volume in 1 s (FEVi) (end of Phase A). Secondary endpoints: morning peak expiratory flow (PEF), rescue medication use and Evaluating Respiratory Symptoms in COPD (E-RSTM: COPD) scores. Safety was assessed. Results: In the intent-to-treat population, the increase in trough FEVI over FF was significant for FF/UMEC 62.5 (0.140 L [p = 0.019]) and 125 mcg (0.120 L [p = 0.039]), with similar changes for patients with a primary diagnosis of asthma or COPD. Changes from baseline in morning PEF and E-RS total score were greater for all FF/UMEC doses vs FF (p <= 0.05). Change from baseline in rescue medication use was statistically or clinically significant for all FF/UMEC doses vs FF. The incidence of on-treatment adverse events was 15%-32% (Phase A), with no dose-related effects. Conclusions: FF/UMEC 62.5 mcg produced clinically meaningful improvements in FEVi, morning PEF, E RS total score and rescue medication use. FF/UMEC may benefit patients with features of both asthma and COPD. (C) 2017 The Authors. Published by Elsevier Ltd.