Dose-ranging study of salmeterol using a novel fluticasone propionate/salmeterol multidose dry powder inhaler in patients with persistent asthma.

Background: New inhalation devices with improved lung delivery malt allow the use of lower of asthma. Objective: To determine the dose of administered from a novel propionate/salmeterol (FS) inhalation driven, multidose dry powder inhaler (MDPI), which provides comparable efficacy and safety to FS dip powder inhaler (DPI). Methods: This double-blind, six-period crossover, dose-ranging study randomozed 72 patienst (ages >= 12 years; with persistent asthma and predose maximum forced expiratory volume in 1 second [FEV1] of 40-85% of the predicted normal) to treatment sequences (one dose per treatment), which consisted of FS MDP1 100/6.25, 100/12.5, 100.50 mu g; fluticasone The primary efficacy variable was the baseline-adjusted FEV1 area under the curve over 12 hours after the dose (AUC(0-12)). Pharmacokinetics and tolerability were also assessed. Results: FEV1 AUC(0-12) was significantly higher with all FS MDPI dose in and FS DPI versus Fp MDPI (p < 0.0001), and with FS MDPI 100/50 mu g versus FS DPI (least squares [LS] mean, 57.88 mL; p = 0.0017): FEV1 AUC(0-12) trended toward higher efficacy with FS MDPI 100/25 mu g (LS mean, 34.14 alL; p = 0.0624) and was comparable with FS MDPI 100/12.5 mu g (LS mean, 3.42 mL; p = 0.8503) versus FS DPI. Salmetcrot area under thlt(i(p/l1a2sayc concentration-versus-tune curve from tune 0 to the time of the last measurable concentration (AUC(0-1)) for FS MDPI I and 100/25 mu g and 100/25 mu g was lower versus FS DPI 100/50 mu g; AUC(0-t) for FS MDPI 100/50 mu g was higher than FS DPI 100/50 mu g. All FS MDPI doses were generally well tolerated. Conclusion: All FS MDPI doses produced greater efficacy versus Fp MDPI. FS MDPI 100/12.5 mu g demonstrated similar efficacy to FS DPI 100/50 mu g with less salmeterol exposure. Clinicaltrials.goo NCT02139644, NCT02175771, and NCT021418554.