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Once-Daily Evening Dosing of Mometasone Furoate Administered Via a Dry Powder Inhaler Does Not Adversely Affect the Hypothalamic-Pituitary-Adrenal Axis.

Author(s): Kosoglou T, Cutler DL, Staudinger H, Herron JM

Affiliation(s): 1 Schering-Plough Research Institute, Kenilworth, NJ, USA;

Publication date & source: 2009-09-14, Chest., [Epub ahead of print]

BACKGROUND: Inhaled corticosteroids can suppress the hypothalamic-pituitary-adrenal (HPA) axis with long-term exposure. This study reports the effects of moderate-dose (400 mug) mometasone furoate administered via dry powder inhaler (MF-DPI) once daily in the evening on the HPA axis in adults with mild to moderate asthma. METHODS: In this randomized, investigator-blind, placebo-controlled trial, nonsmoking adults ages 18-50 years with mild to moderate asthma received once-daily MF-DPI 400 mug (2x200 mug/inhalation; treatment A), MF-DPI 400 mug (1x400 mug/inhalation; treatment B), or placebo (2 inhalations, treatment C) delivered approximately 8pm, for 42 days. Primary endpoints were area under the serum cortisol concentration-versus-time curve over 24 hours (AUC(0-24)), 24-hour urinary free cortisol (creatinine corrected) on day 42, maximum serum cortisol concentration (C(max)), time to C(max) (T(max)), and 8am serum cortisol concentration. RESULTS: Serum cortisol AUC(0-24), C(max), and 24-hour urinary free cortisol levels decreased with all treatments by day 42 with no significant differences between groups. For treatment B, the change in 8am serum cortisol from baseline to day 42 was significantly less than placebo (P=0.04), attributed to a large baseline difference between these treatments. A significant difference in T(max) change from baseline by day 42 for treatment B compared with the other treatments (P=0.019) was also attributed to significant baseline differences between groups. Actual values at day 42 for T(max) and 8am serum cortisol were not significantly different between treatment groups (P>/=0.275). CONCLUSIONS: Once-evening moderate dosing (400 mug) MF-DPI does not suppress HPA- axis function in adults with mild to moderate asthma.

Page last updated: 2009-10-20

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