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): Early Clinical Research & Experimental Medicine, Schering-Plough Research
Institute, 2015 Galloping Hill Road (K-15-4, 4455), Kenilworth, NJ 07033, USA.
teddy.kosoglou@spcorp.com
Publication date & source: 2010, Chest. , 137(1):115-21
BACKGROUND: Inhaled corticosteroids can suppress the
hypothalamic-pituitary-adrenal (HPA) axis with long-term exposure. This study
reports the effects of moderate-dose (400 microg) 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 microg (2 x 200 microg/inhalation; treatment A), MF-DPI 400
microg (1 x 400 microg/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
(AUC(0-24)), 24-h urinary free cortisol (creatinine corrected) on day 42, maximum
serum cortisol concentration (C(max)), time to C(max) (T(max)), and 8 :00 am
serum cortisol concentration. This study was initiated April 16, 2001 and
completed June 14, 2001.
RESULTS: Serum cortisol AUC(0-24), C(max), 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 T(max)
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 T(max) and 8:00 am serum cortisol were not
significantly different between treatment groups (P > or = .275).
CONCLUSIONS: Once-evening moderate dosing (400 microg) MF-DPI does not suppress
HPA axis function in adults with mild to moderate asthma.
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