Abstracts: Poster Sessions / Ann Allergy Asthma Immunol 117 (2016) S22eS124
despite lower nominal doses, compared with the established DPI device, suggesting improved efﬁciency due to formulation and device differences.
Conclusion: Beclomethasone dipropionate BAI 80 and 160 mcg/ day were effective and well accepted treatments in patients with asthma.
EVALUATION OF BECLOMETHASONE DIPROPIONATE (80 AND 160 MCG/DAY) DELIVERED VIA BREATHACTUATED INHALER FOR PERSISTENT ASTHMA D. Miller1, F. Hampel2, W. Carr*3, M. Gillespie4, C. Small4, 1. North Dartmouth, MA; 2. New Braunfels, TX; 3. Mission Viejo, CA; 4. Frazer, PA.
CORRECT AND EASE OF USE FOR A DRY POWDER INHALER IN ASTHMA/CHRONIC OBSTRUCTIVE PULMONARY DISEASE G. Feldman*1, V. Imber2, D. Galkin3, P. Patel2, K. Collison3, R. Sharma4, 1. Spartanburg, SC; 2. Uxbridge, United Kingdom; 3. Research Triangle Park, NC; 4. Brentford, United Kingdom.
Introduction: The efﬁcacy and safety of beclomethasone dipropionate delivered via a novel breath-actuated inhaler (BAI) versus placebo in asthmatic patients was evaluated. Methods: This phase 3, 12-week, double-blind study (NCT02040779) included patients with asthma aged >/¼12 years and treated with a stable dose of inhaled corticosteroid or noncorticosteroid therapy. After a 14- to 21-day run-in period, patients were randomized to beclomethasone dipropionate 80 or 160 mcg/ day (40 or 80 mcg twice daily) delivered via BAI or matching placebo BAI. Standardized baseline-adjusted trough morning forced expiratory volume over 1 second (FEV1) area under the effect curve (AUEC) was evaluated from time 0 to 12 weeks (FEV1 AUEC[012wk]; primary endpoint). Secondary endpoints evaluated other pulmonary function measures, rescue medication use, and asthma symptoms; additional endpoints evaluated quality of life, instructions for use, and safety. Results: The full analysis and safety sets included 270 and 273 patients, respectively. Patients receiving beclomethasone dipropionate BAI 80 or 160 mcg/day had signiﬁcant improvements in FEV1 AUEC(0-12wk) versus placebo patients (Table). Patients receiving beclomethasone dipropionate BAI 80 or 160 mcg/day also had improvements in secondary endpoints versus placebo (Table). Patients receiving beclomethasone dipropionate BAI 80 or 160 mcg/day had greater increases in Asthma Quality of Life Questionnaire scores versus placebo patients at week 12. Of 98 patients who participated in the instructions for use substudy, 87 used the inhaler successfully on the ﬁrst try. Treatment was generally safe and well tolerated.
Introduction: For effective self-delivery of inhaled medications, inhalers should be easy to operate correctly. Two multi-center, single-arm, placebo, Phase IV studies were conducted to evaluate correct use and ease of use for a licensed multi-dose dry powder inhaler (DPI) with twin-strip technology (GSK) in adults with asthma (GSK study 201594/NCT02586506) or COPD (GSK study 201071/NCT02586493). Methods: Asthma/COPD patients receiving maintenance therapy, but with no prior/ongoing study inhaler use (within 6 months for COPD), were eligible. Patients demonstrating correct inhaler use within three attempts at screening were instructed to take oncedaily inhalations from the placebo inhaler for 282 days, whilst continuing usual maintenance therapy. At study end, patients were randomized 1:1 to complete one of two versions of an ease-of-use questionnaire and were re-assessed for correct inhaler use. Results: 259 asthma/278 COPD patients were included: median age 49/65 years, 64%/47% female. At study end, 96%/93% rated the inhaler as ‘easy’ or ’very easy’ to use and demonstrated correct inhaler use (Table); overall, 98%/97% demonstrated correct inhaler use at study end. Further, 99%/99% indicated it was ‘easy’ or ’very easy’ to determine the number of doses remaining and 81%/84% indicated they would be ‘likely’ or ’very likely’ to request their current prescribed medication in the study inhaler, if available. AE rates were 12%/15%; the most frequent AE was headache (3%/3%). Treatment-related AEs were reported in one asthma patient (cough)/four COPD patients (cough, n¼3; back pain, n¼1). Conclusions: This DPI was operated correctly and rated ‘easy’ or ‘very easy’ to use by the majority of asthma/COPD patients.
Key results *Modiﬁed intent-to-treat (mITT) population; all patients who were screened (Visit 1), who received at least 1 dose of placebo study treatment, and who were randomized to receive the ease-ofuse questionnaire at study end (Visit 2). In both studies, the mITT population was used for analysis of the pre-speciﬁed primary and secondary endpoints. yOne patient in the COPD mITT population was randomized in error and did not complete the ease-of-use questionnaire. zEasy to use was deﬁned as a rating of ‘easy’ or ‘very easy’ on a 4-point scale (very easy, easy, difﬁcult, very difﬁcult). xPatients demonstrating correct use of the study inhaler on the ﬁrst attempt (i.e. without training/additional instruction) at study end (Visit 2) as assessed by the inhaler-trained health care professional.