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Original Research: ASTHMA |

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

Teddy Kosoglou, PharmD; David L. Cutler, MD; Heribert Staudinger, MD, PhD; Jerry M. Herron, MD
Author and Funding Information

From the Schering-Plough Research Institute (Drs Kosoglou, Cutler, and Staudinger), Kenilworth, NJ; and the Arkansas. Research Medical Testing Center (Dr Herron), Little Rock, AR.

Correspondence to: Teddy Kosoglou, PharmD, Senior Director, Early Clinical Research & Experimental Medicine, Schering-Plough Research Institute, 2015 Galloping Hill Road (K-15-4, 4455), Kenilworth, NJ 07033; e-mail: teddy.kosoglou@spcorp.com


Funding/Support: This study was supported by Schering-Plough.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/site/misc/reprints.xhtml).


© 2010 American College of Chest Physicians


Chest. 2010;137(1):115-121. doi:10.1378/chest.09-0235
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Background:  Inhaled corticosteroids can suppress the hypothalamic-pituitary-adrenal (HPA) axis with long-term exposure. This study reports the effects of moderate-dose (400 μg) 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 aged 18 to 50 years with mild-to-moderate asthma received once-daily MF-DPI 400 μg (2 × 200 μg/inhalation; treatment A), MF-DPI 400 μg (1 × 400 μg/inhalation; treatment B), or placebo (two inhalations, treatment C), delivered at approximately 8:00 pm, for 42 days. Primary end points were area under the serum cortisol concentration-vs-time curve over 24 h (AUC0-24), 24-h urinary free cortisol (creatinine corrected) on day 42, maximum serum cortisol concentration (Cmax), time to Cmax (Tmax), and 8 :00 am serum cortisol concentration. This study was initiated April 16, 2001 and completed June 14, 2001.

Results:  Serum cortisol AUC0-24, Cmax, and 24-h urinary free cortisol levels decreased with all treatments by day 42 with no significant differences between groups. For treatment B, the change in 8:00 am serum cortisol from baseline to day 42 was significantly less than placebo (P = .04), attributed to a large baseline difference between these treatments. A significant difference in Tmax change from baseline by day 42 for treatment B compared with the other treatments (P = .019) was also attributed to significant baseline differences between groups. Actual values at day 42 for Tmax and 8:00 am serum cortisol were not significantly different between treatment groups (P ≥ .275).

Conclusions:  Once-evening moderate dosing (400 μg) MF-DPI does not suppress HPA axis function in adults with mild to moderate asthma.

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