Published ahead of print on June 7, 2004, doi:10.1164/rccm.200404-500OC Am. J. Respir. Crit. Care Med., Volume 170, Number 9, November 2004, 960-966 A more recent version of this article appeared on November 1, 2004
Submitted on April 16, 2004 Adrenal Suppression with Dry Powder Formulations of Fluticasone Propionate and Mometasone FuroateTom C Fardon1,1 Department of Medicine and Therapeutics, Asthma and Allergy Research Group, University of Dundee, Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom * To whom correspondence should be addressed. E-mail: b.j.lipworth{at}dundee.ac.uk.
Mometasone furoate (MF) and fluticasone propionate (FP) are high potency inhaled corticosteroids (ICS). The systemic bioavailability of MF is claimed to be negligible, leading to a minimal potential for systemic adverse effects. We assessed the overnight urinary cortisol/creatinine as the primary outcome of adrenal suppression in 21 patients with persistent asthma (mean FEV1 = 91 %). Patients were randomised in a cross over fashion to receive two weekly consecutive doubling incremental doses of either FP Accuhaler (500, 1000, 2000 µg/day) or MF Twisthaler (400, 800, 1600 µg/day). For the 21 per protocol completed patients, there was significant suppression of overnight urinary cortisol/creatinine with high and medium doses of both drugs - as geometric mean-fold suppression (95 % CI) from baseline: FP 2000 µg 1.85 (1.21-2.82; p = 0.002); FP 1000 µg 1.45 (1.07-1.96; p = 0.02); MF 1600 µg 1.92 (1.26-2.93; p = 0.001); MF 800 µg 1.39 (1.04-1.88; p = 0.02). For secondary outcomes of 8am plasma cortisol, serum osteocalcin, and early morning urinary cortisol/creatinine, there was significant suppression with MF and FP at the highest dose. Our data refutes the assertion that MF has negligible systemic bioavailability and a lower potential for systemic adverse effects compared with FP. Key words: Asthma, Systemic Bioavailability, Hypothalamic-Pituitary-Adrenal axis, Mometasone Furoate
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