A new formulation of fluticasone propionate/salmeterol in a metered-dose inhaler (MDI HFA) allows for the reduction of a daily dose of corticosteroid and provides optimal asthma control - A randomized, multi-center, non-inferiority, phase IV clinical study.

BACKGROUND: Improvement of the delivery method of inhaled corticosteroids and subsequent dose reduction can minimize the risk of unfavorable outcomes while providing optimal asthma control. OBJECTIVE: This randomized, multi-center, non-inferiority, phase IV clinical study compared the efficacy and safety of a new formulation of fluticasone propionate/salmeterol (250 µg/50 µg, twice daily) administered in a metered-dose inhaler hydrofluoroalkane (MDI HFA) with a dry-powder inhaler (DPI) containing fluticasone propionate/salmeterol (500 µg/50 µg, twice daily). METHODS: Adults with asthma (n = 231) were randomly assigned to either the study group (treated for 12 weeks with fluticasone propionate/salmeterol MDI HFA) or a control group (treated for 12 weeks with fluticasone propionate/salmeterol DPI). Asthma symptoms, exacerbations, short-acting ß2-agonist (SABA) use, physical activity, lung function, and general health status were assessed during four study visits. RESULTS: Compared with the reference drug, the study drug decreased the incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity. Comparable improvement in peak expiratory flow ([MDI HFA] from 6.2 ± 0.2 to 6.6 ± 0.2 l/s vs. [DPI] from 6.0 ± 0.2 to 6.9 ± 0.2 l/s; p > 0.05), forced expiratory volume in one second, and forced vital capacity were obtained in both groups. Significantly lower incidence of hoarseness was observed in the study group ([MDI HFA] 0.0% vs. [DPI] 2.8%; p = 0.0267); no major differences were found for other adverse events. CONCLUSIONS: Fluticasone propionate/salmeterol (250 µg/50 µg, twice daily) MDI HFA provides optimal asthma control and is non-inferior to fluticasone propionate/salmeterol (500 µg/50 µg, twice daily) DPI.

Ultra high efficiency/low pressure supercritical fluid chromatography (UHE/LP-SFC) for triglyceride analysis: Identification, quantification, and classification of vegetable oils.

Triglycerides of vegetable oils have been extensively studied. Non-aqueous reversed-phase liquid chromatography and silver-ion chromatography are most frequently used to achieve their separation. In previous works, we presented the use of supercritical fluid chromatography with long columns (75 cm) packed with fused-core particles to provide ultra-high-performance separations, with a low-toxicity fluid (carbon dioxide) compared to the usual liquid-phase methods. In the present paper, we describe the quantification of triglycerides with supercritical fluid chromatography and evaporative light-scattering detection. Thanks to the isocratic elution mode, this quantification can be simplified, assuming (a) identical response coefficients for compounds having a close structure, (as only triglycerides are quantified), and (b) constancy of the response coefficient along the analysis (no elution gradient). Therefore, the relative concentrations of triglycerides were easily assessed. Only one calibration curve for one reference compound (in this case triolein) was required. The resulting relative concentrations are in good accordance with the numerous publications available. Relative quantification with UV detection at 210 nm is also proposed, facilitated by the very low UV absorption of carbon dioxide and with a calibration curve taking account of the variation of UV response according to double bond number. Nineteen vegetable oils are compared. The identification of triglycerides was carried out based on previous knowledge of these oils, but also with the help of a Goiffon retention diagram, based on the relationship between the logarithm of retention factor and the total double bond number. Finally, cluster analyses were computed, based on evaporative light-scattering detection or UV quantification data. They allow a quick comparison of the triglyceride content between the oils, in the goal to exchange one by the other for certain applications, or to compare a new oil to well-known ones.