PURPOSE: Indacaterol is a novel, inhaled, once-daily, long-acting β2-agonist for COPD, delivered by a single-dose dry-powder inhaler (SDDPI; Breezhaler(r) in Europe). This study assessed patients’ handling and preference for Breezhaler versus the SDDPI (HandiHaler(r)) used with tiotropium.
METHODS: In an open-label, crossover study, COPD patients (no previous experience of either device) used Breezhaler or HandiHaler with placebo capsules daily for 7 days in random sequence, added to usual treatment. On Day 1, after patients read written instructions for use, trained assessors determined patients’ ability to perform each of 21 steps required for correct use of Breezhaler and 19 for HandiHaler. For each device, two steps were deemed essential to correct use. The assessors then trained patients in correct device use. Patients were assessed again on Day 7. Patients then completed a preference questionnaire.
RESULTS: Data were analyzed from 82 patients with mild to severe COPD (mean age 64 years). At Day 7, most patients (78-100% for Breezhaler; 81-100% for HandiHaler) completed each handling step correctly. For most steps there was improvement from Day 1 to Day 7 (corresponding Day 1 rates were 81-100% and 69-99%). For one key step (fully releasing button before inhalation), the Breezhaler score was high on both days (93%, 96%), while the HandiHaler score changed 11 points from 88% (Day 1) to 99% (Day 7). Overall, patients preferred Breezhaler (61%) over HandiHaler (31%). Breezhaler was preferred for ease of opening and closing cap and mouthpiece, ease of holding, checking inhalation, and confidence that medication was taken. HandiHaler was preferred for inserting/removing capsules.
CONCLUSION: Most patients used both devices correctly after 7 days. Patient training had a greater effect on HandiHaler use than Breezhaler. Patients preferred Breezhaler as the inhaler for continued daily use.
CLINICAL IMPLICATIONS: Patients preferred Breezhaler over HandiHaler. Patients were more likely to be able to use Breezhaler correctly after written instructions only (as typically occurs in clinical use). These are important factors for adherence and successful disease management.
DISCLOSURE: Kenneth Chapman, University grant monies N/A; Grant monies (from sources other than industry) N/A; Grant monies (from industry related sources) Kenneth Chapman has undertaken research funded by AstraZeneca, Boehringer-Ingelheim, CSL Behring, Forest Labs, GlaxoSmithKline, Novartis, Parangenix, Roche and Talecris; and has participated in continuing medical education activities sponsored in whole or in part by AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Grifols, Merck Frosst, Novartis, Nycomed, Pfizer and Talecris. Charles Fogarty has received grants for clinical trials from Novartis, Roche, GSK, Dey and Forest.; Shareholder NA; Employee Clare Peckitt, Cheryl Lassen and Benjamin Kramer are employees of the study sponsor, Novartis.; Fiduciary position (of any organization, association, society, etc, other than ACCP N/A; Consultant fee, speaker bureau, advisory committee, etc. Kenneth Chapman has received compensation for consulting with Astra Zeneca, Boehringer-Ingelheim, CSL Behring, GlaxoSmithKline, Merck Frosst, Novartis, Nycomed, Pfizer, Roche, Schering Plough and Telacris.; Other N/A; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Indacaterol is an investigational drug that has not yet been approved in the United States for the treatment of COPD.