A Randomized, Crossover Trial Evaluating Patient Handling, Preference, and Ease of Use of the Fluticasone Propionate/Formoterol Breath-Triggered Inhaler.

BACKGROUND: Appropriate inhaler selection is of fundamental importance in obstructive lung disease management. Key factors in device selection include a patient's capacity to operate a particular device and their preference for it.

METHODS: This randomized, open-label, two-period, crossover study (NCT01739387) compared the ability of adolescent and adult patients with obstructive lung disease to correctly handle the fluticasone propionate/formoterol fumarate (FP/FORM; Flutiform® ) pressurized metered-dose inhaler (pMDI) and FP/FORM K-haler® , a novel breath-triggered inhaler (BTI), following a simple, standardized training regimen. The primary endpoint was the ability to perform all steps correctly at the first attempt. Secondary endpoints included the ability to perform all critical steps correctly at the first attempt, the requisite number of attempts to successfully use the inhaler, the ability to be trained within 15 minutes, and the ability to trigger the K-haler BTI to actuate at the first attempt. Ease of device use and device preference versus patients' usual maintenance inhalers were also assessed.

RESULTS AND CONCLUSIONS: At the first attempt, an identical proportion (77.2% [95% confidence interval [CI]: 72.1, 81.8]) of 307 patients performed all pMDI and K-haler BTI handling steps correctly, whereas the corresponding proportions performing all critical steps correctly were 82.4% (95% CIs: 77.7, 86.5) and 87.0% (95% CI: 82.7, 90.5), respectively. For both devices, >90% of patients required only two attempts to master device usage; >99% of patients could be trained to correctly use each device within 15 minutes. Virtually all patients (99.0% [95% CIs: 97.2, 99.8]) were able to successfully trigger the K-haler BTI's dose-release mechanism at first attempt. Ease of use and preference data for FP/FORM pMDI challenged the perceived wisdom that dry powder inhalers are necessarily simpler to use, whereas the corresponding data for FP/FORM K-haler strongly favored this novel BTI over the Turbuhaler® , Accuhaler® , and other pMDIs.