0
Poster Presentations: Wednesday, October 26, 2011 |

The Effect of Mometasone Furoate/Formoterol Combination Therapy on Chronic Obstructive Pulmonary Disease (COPD) Exacerbations: Results From Two Phase Three Trials in Subjects With Moderate to Very Severe COPD FREE TO VIEW

Donald Tashkin, MD; Dennis Doherty, MD; Edward Kerwin, MD; Carlos Eduardo Matiz-Bueno, MD; Tulin Shekar, MS; Sibabrata Banerjee, PhD; Jonathan Sadeh, MD
Chest. 2011;140(4_MeetingAbstracts):549A. doi:10.1378/chest.1119324
Text Size: A A A
Published online

Abstract

PURPOSE: The ability to reduce and/or prevent exacerbations is an important characteristic of effective chronic obstructive pulmonary disease (COPD) treatment. Mometasone furoate (MF) and formoterol (F) have been investigated as COPD treatments in multiple studies. However, the therapeutic effect of their combined administration via a metered-dose inhaler (MDI) in reducing COPD exacerbations has not been well elucidated. We investigated the effect of MF/F on COPD exacerbations in subjects with moderate−very severe COPD using data from 2 clinical trials.

METHODS: The effect of MF/F on COPD exacerbations was assessed by measuring the time to first mild (≥12 inhalations or ≥2 nebulized treatments of rescue medication/day), moderate (treatment with antibiotics or oral steroids), or severe (emergency room treatment or hospitalization) exacerbation in 2 independent, 26-wk, multicenter, double-blind, placebo (PBO)-controlled trials conducted in adults (≥40 y) with moderate−very severe COPD. In each trial (prebronchodilator FEV1/forced vital capacity ratio ≤0.7 and postbronchodilator FEV1 ≤60% predicted), subjects were randomized to twice-daily (BID) MF/F 400/10µg (n1=217; n2=225), MF/F 200/10µg (n1=207; n2=239), MF 400µg (n1=210; n2=253), F 10µg (n1=209; n2=243), or PBO (n1=212; n2=236).

RESULTS: In Trial 1 (N=1055), significant reductions in moderate−severe exacerbations were observed in subjects treated with MF/F 400/10µg compared with those on PBO (8.8% vs 16.5%; P=0.009). In Trial 2 (N=1196), significant reductions in mild, moderate, or severe exacerbations were observed in the MF/F 400/10µg and MF/F 200/10µg groups compared with the PBO group (37.6% and 32.3% vs 45.7%; P≤0.027). Also in trial 2, significant reductions in moderate−severe exacerbations were observed in the MF/F 400/10µg and MF/F 200/10µg groups compared with the PBO group (15.4% and 12.8% vs 24.6%; P≤0.006). A pooled analysis of both studies indicated that MF/F 400/10µg and MF/F 200/10µg were associated with relative risk reductions in moderate−severe exacerbations of 41.5% and 34.6%, respectively..

CONCLUSIONS: Subjects with moderate−very severe COPD treated with the combination of MF/F administered via a MDI experienced significant reductions in the incidence of moderate−severe exacerbations.

CLINICAL IMPLICATIONS: MF/F treatment reduces exacerbations in patients with moderate−very severe COPD.

DISCLOSURE: Donald Tashkin: University grant monies: Merck, Consultant fee, speaker bureau, advisory committee, etc.: Merck

Dennis Doherty: University grant monies: Boehringer Ingelheim, Merck, Novartis, Pfizer, Grant monies (from sources other than industry): NIH-NHLBI, Department of Veterans Affairs, Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, Boehringer-Ingelheim, Forest, Ikaria, Merck, Pfizer

Edward Kerwin: Grant monies (from industry related sources): Merck

Carlos Eduardo Matiz-Bueno: Other: Spouse is an employee at Merck

Tulin Shekar: Employee: Merck

Sibabrata Banerjee: Employee: Merck

Jonathan Sadeh: Employee: Merck

No Product/Research Disclosure Information

09:00 AM - 10:00 AM


Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

CHEST Journal Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543