Dose-ranging study of salmeterol using a novel fluticasone propionate/salmeterol multidose dry powder inhaler in patients with persistent asthma
New inhalation devices with improved lung delivery may allow the use of lower salmeterol doses for treatment of asthma.
To determine the dose of salmeterol administered from a novel fluticasone propionate/salmeterol (FS) inhalation‐driven, multidose dry powder inhaler (MDPI), which provides comparable efficacy and safety to FS dry powder inhaler (DPI).
This double-blind, six-period crossover, dose-ranging study randomized 72 patients (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 MDPI 100/6.25, 100/12.5, 100/25, 100/50 μg; fluticasone propionate (Fp) MDPI 100 μg; and open-label FS DPI 100/50 μg. The primary efficacy variable was the baseline-adjusted FEV1 area under the curve over 12 hours after the dose (AUC0‐12). Pharmacokinetics and tolerability were also assessed.
FEV1 AUC0‐12 was significantly higher with all FS MDPI doses and FS DPI versus Fp MDPI (p < 0.0001), and with FS MDPI 100/50 μg versus FS DPI (least squares [LS] mean, 57.88 mL; p = 0.0017). FEV1 AUC0‐12 trended toward higher efficacy with FS MDPI 100/25 μg (LS mean, 34.14 mL; p = 0.0624) and was comparable with FS MDPI 100/12.5 μg (LS mean, 3.42 mL; p = 0.8503) versus FS DPI. Salmeterol area under the plasma concentration-versus-time curve from time 0 to the time of the last measurable concentration (AUC0-t) for FS MDPI 100/12.5 μg and 100/25 μg was lower versus FS DPI 100/50 μg; AUC0-t for FS MDPI 100/50 μg was higher than FS DPI 100/50 μg. All FS MDPI doses were generally well tolerated.
All FS MDPI doses produced greater efficacy versus Fp MDPI. FS MDPI 100/12.5 μg demonstrated similar efficacy to FS DPI 100/50 μg with less salmeterol exposure. Clinicaltrials.gov NCT02139644, NCT02175771, and NCT02141854
Document Type: Research Article
Affiliations: Northeast Medical Research Associates, North Dartmouth, MA, USA
Publication date: July 1, 2016
This article was made available online on May 27, 2016 as a Fast Track article with title: "Dose-ranging study of salmeterol using a novel fluticasone propionate/salmeterol multidose dry powder inhaler in patients with persistent asthma".
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