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Original Research: Asthma |

Hypothalamic-Pituitary-Adrenal Axis Effects of Mometasone Furoate/Formoterol Fumarate vs Fluticasone Propionate/Salmeterol Administered Through Metered-Dose InhalerSystemic Effects of Mometasone Furoate

Teddy Kosoglou, PharmD; James Hubbell, PhD; David L. Cutler, MD; Amy O. Johnson-Levonas, PhD; Danlin Xu, PhD; Bhavna S. Kantesaria, MS; Kenneth Kim, MD; S. David Miller, MD
Author and Funding Information

From Merck & Co, Inc (Drs Kosoglou, Hubbell, Cutler, Johnson-Levonas, and Xu and Ms Kantesaria), Whitehouse Station, NJ; WCCT Global (Dr Kim), Cypress, CA; and Northeast Medical Research Associates (Dr Miller), North Dartmouth, MA.

Corresponding author: David L. Cutler, MD, Clinical Pharmacology, Merck & Co, Inc, 351 N Sumneytown Pike, UG4-D34, North Wales, PA 19454; e-mail: david.cutler@merck.com


Part of this article has been presented in abstract form (Kosoglou T, Hubbell J, Xuan F, et al. Chest. 2012;142(4_MeetingAbstracts):685A).

Funding/Support: Schering Corporation (now Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc) provided funding for the conduct of the study.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2013;144(6):1795-1802. doi:10.1378/chest.13-0505
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Background:  The effects of mometasone furoate and fluticasone propionate on the hypothalamic-pituitary-adrenal axis were compared when administered from combination metered-dose inhaler (MDI) products.

Methods:  In a randomized, open-label, placebo-controlled, parallel group study, 66 patients with mild to moderate asthma received one of the following four treatments bid through an MDI for 42 days: mometasone furoate/formoterol (MF/F) 200 μg/10 μg, MF/F 400 μg/10 μg, fluticasone propionate/salmeterol (FP/S) 460 μg/42 μg, or placebo. Plasma cortisol concentrations were measured over 24 h on days −1 (baseline) and 42. Geometric mean ratio (GMR) and 90% CI for mean change from baseline to day 42 in 24-h plasma cortisol area under the curve (AUC) were calculated for each treatment. If the 90% CI for the GMRs fell within 70% to 143%, treatments were deemed comparable.

Results:  Mean baseline cortisol AUCs were similar across groups. Mean cortisol effects (change from baseline) were similar for MF/F 400 μg/10 μg and FP/S 460 μg/42 μg (GMR, 119%; 90% CI, 101%-140%). Effects of MF/F 200 μg/10 μg on cortisol AUC were similar to placebo (GMR, 92%; 90% CI, 78%-110%), whereas MF/F 400 μg/10 μg and FP/S 460 μg/42 μg lowered cortisol AUC vs placebo (GMR, 78% [90% CI, 66%-92%] and 66% [90% CI 56%-78%], respectively). All treatments were generally well tolerated.

Conclusions:  MF/F 400 μg/10 μg or FP/S 460 μg/42 μg bid through an MDI led to similar reductions from baseline in mean cortisol AUC (22% and 34% lower than placebo, respectively), whereas the effect of MF/F 200 μg/10 μg was similar to placebo.

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