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Slide Presentations: Sunday, October 31, 2010 |

Low-, Medium-, and High-Dose Mometasone Furoate/Formoterol Improves Lung Function in Persistent Asthmatics FREE TO VIEW

Eli O. Meltzer, MD; Robert A. Nathan, MD; Steven F. Weinstein, MD; Hendrik Nolte, PhD
Author and Funding Information

Allergy and Asthma Medical Group and Research Center, San Diego, CA



Chest. 2010;138(4_MeetingAbstracts):706A. doi:10.1378/chest.10396
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Abstract

PURPOSE: To evaluate lung function outcomes in persistent asthma subjects receiving mometasone furoate/formoterol (MF/F), a new inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) combination.

METHODS: Three phase III, randomized, multicenter, double-blind studies were conducted in moderate-to-severe asthma subjects previously receiving ICS±LABA therapy: 1) study P04073: MF/F(100/10μg), MF(100μg), F(10μg), and placebo (n=182, n=188, n=188, n=188, respectively; 26weeks; 2-3week active run-in MF[100μg]); 2) study P04334: MF/F(200/10μg), MF(200μg), F(10μg), and placebo (n=191, n=192, n=202, n=196, respectively; 26weeks; 2-3week active run-in MF[200μg]); 3) study P04431: MF/F(400/10μg), MF/F(200/10μg), and MF(400μg) (n=255, n=233, n=240, respectively; 12weeks; 2-3week active run-in MF[400μg]). All doses were twice-daily. Area under the curve from 0−12 hours for the change from baseline to week-12 in forced expiratory volume in 1 second (FEV1AUC0-12h) and change from baseline in combined morning/evening (AM/PM) peak expiratory flow (PEF) at week-12 and study endpoint were assessed.

RESULTS: Week-12 FEV1AUC0-12h was significantly higher for: MF/F(100/10μg) versus MF(100μg) and placebo (4.00 vs 2.53 and 1.11 Lxh, respectively, P≤0.001) in study P04073; MF/F(200/10μg) versus MF(200μg), F(10μg), and placebo (3.11 vs 1.30, 1.93, and 0.57 Lxh, respectively, P≤0.017) in study P04334; and MF/F(200/10μg) and MF/F(400/10μg) versus MF(400μg) (3.59 and 4.19 vs 2.04 Lxh, respectively, P<0.001) in study P04431. Change from baseline in week-12 and endpoint AM/PM PEF was significantly higher for: MF/F(100/10μg) versus MF(100μg), F(10μg), and placebo (week-12: 5.3% vs 1.6%, 2.6%, and −2.4%, respectively, P≤0.007; endpoint: 4.4% vs −0.3%, 0.7%, and −5.5%, respectively, P<0.001) in study P04073; MF/F(200/10μg) versus MF(200μg), F(10μg), and placebo (week-12: 6.9% vs 2.6%, 1.3%, and −3.3%, respectively, P<0.001; endpoint: 5.9%; vs 1.5%, −3.5%, and −6.6%, respectively, P≤0.003) in study P04334; and MF/F(200/10μg) and MF/F(400/10μg) versus MF(400μg) (week-12: 11.5% and 13.4% vs 7.0%, respectively, P≤0.003; endpoint: 11.8% and 12.6% vs 6.6%, respectively, P<0.001) in study P04431.

CONCLUSION: Three different MF/F doses significantly improved lung function outcomes compared with MF, F, and placebo in moderate-to-severe persistent asthmatics.

CLINICAL IMPLICATIONS: MF/F provides improved lung function in patients who are unable to adequately control their asthma with ICS monotherapy.

DISCLOSURE: Eli Meltzer, Grant monies (from industry related sources) Dr. Meltzer has received grant/research support from Schering-Plough, has served as a consultant for the company, and is on their Speaker's Bureau.Dr. Nathan has received grants and research support from Abbott, Alcon, AstraZeneca, Ception, Dey, Dyax, Genentech, GlaxoSmithKline, MAP, MedImmune, Novartis, Sanofi-Aventis, Schering-Plough, and TEVA.; Employee Dr. Nolte is a full-time Employee of Merck Research Laboratories; Consultant fee, speaker bureau, advisory committee, etc. Dr. Meltzer has received grant/research support from Schering-Plough, has served as a consultant for the company, and is on their Speaker's Bureau.Dr. Nathan has served as consultant or scientific advisor for Genentech, GlaxoSmithKline, Merck, Novartis, Schering-Plough, and TEVA. Dr. Nathan has also participated in Speaker's Bureaus for AstraZeneca, Genentech, GlaxoSmithKline, Novartis, Sanofi-Aventis, Schering-Plough and UCB.; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Mometasone furoate/formoterol is a new ICS/LABA combination treatment currently under review by the US Food and Drug Administration as a potential new treatment for persistent asthma.

09:45 AM - 11:00 AM


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