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International Journal of Chronic Obstructive Pulmonary Disease Volume 7, 2012 - Issue
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Original Research

Efficacy and safety of a fixed-dose combination of mometasone furoate and formoterol fumarate in subjects with moderate to very severe COPD: results from a 52-week Phase III trial

Donald P Tashkin1 David Geffen School of Medicine at UCLA, Los Angeles, CACorrespondence[email protected]
,
Dennis E Doherty2 Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky, Lexington, KY
,
Edward Kerwin3 Clinical Research Institute of Southern Oregon, Medford, OR USA
,
Carlos E Matiz-Bueno4 Fundación Salud Bosque, Bogota, Colombia
,
Barbara Knorr5 Merck Sharp & Dohme Corp, Whitehouse Station, NJ USA
,
Tulin Shekar5 Merck Sharp & Dohme Corp, Whitehouse Station, NJ USA
,
Sibabrata Banerjee5 Merck Sharp & Dohme Corp, Whitehouse Station, NJ USA
&
Heribert Staudinger5 Merck Sharp & Dohme Corp, Whitehouse Station, NJ USA
 show all
Pages 43-55 | Published online: 03 Feb 2012

Figures & data

Figure 1 Study design schematic.

Note: Total doses were delivered after two inhalations twice daily of the following actuated doses: MF/F 200/5 μg, MF 100/5 μg, MF 200 μg, F 5 μg, or placebo. a75% of each group were randomly selected to continue into the safety extension.
Abbreviations: bid, twice daily; F, formoterol; MDI, metered-dose inhaler; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixed-dose combination.
Figure 1 Study design schematic.

Table 1 Disposition of patients following randomized treatment assignment: number (%) of patients during the treatment period

Table 2 Summary of demographic data and baseline characteristics (all randomized subjects)

Table 3 Change from baseline in standardized FEV1 AUC0–12 h (mL)

Figure 2 FEV1 AUC0–12 h week 13 last observation carried forward results (all randomized subjects).

Abbreviations: AUC, area under curve; FEV1, forced expiratory volume in 1 second; F, formoterol; MDI, metered-dose inhaler; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixed-dose combination.
Figure 2 FEV1 AUC0–12 h week 13 last observation carried forward results (all randomized subjects).

Figure 3 Serial FEV1 postdose at day 1 (A) and week 26 (B).

Notes: Significantly greater increases in FEV1 occurred with MF/F 400/10 versus MF 400 at all time points on day 1 (P ≤ 0.009) and week 26 (P ≤ 0.042). Significant increases in FEV1 with MF/F 200/10 versus MF 400 occurred through 10 hours on day 1 (P ≤ 0.015) and 4 hours on week 26 (P ≤ 0.026). Compared with F 10, MF/F 400/10 had significantly greater increases in FEV1 at all time points in week 26 (P < 0.05), whereas MF/F 200/10 had significantly greater increases than F 10 at hours 8, 10, and 12 postdose in week 26 (P ≤ 0.025).
Abbreviations: bid, twice daily; FEV1, forced expiratory volume in 1 second; F, formoterol; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixed-dose combination.
Figure 3 Serial FEV1 postdose at day 1 (A) and week 26 (B).

Figure 4 St George’s Respiratory Questionnaire total score change from baseline at week 26 endpoint.

Note: Treatment with MF/F 400/10 achieved a statistically significant difference from placebo, which satisfied this key secondary endpoint and surpassed the MCID of 4.0.
Abbreviations: F, formoterol; LS, least squares; MCID, minimum clinically important difference; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixeddose combination; SGRQ, St George’s Respiratory Questionnaire.
Figure 4 St George’s Respiratory Questionnaire total score change from baseline at week 26 endpoint.

Figure 5 Time-to-first mild, moderate or severe COPD exacerbation over the 26-week treatment period: Kaplan-Meier survival curves by treatment (all randomized subjects).

Abbreviations: COPD, chronic obstructive pulmonary disease; F, formoterol; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixed-dose combination.
Figure 5 Time-to-first mild, moderate or severe COPD exacerbation over the 26-week treatment period: Kaplan-Meier survival curves by treatment (all randomized subjects).

Table 4 Summary of treatment-emergent adverse events

Table 5 Summary of treatment-emergent adverse events ≥2% incidence (all randomized subjects) during the treatment period

Table 6 Summary of treatment-emergent adverse events ≥2% incidence (all randomized subjects) during the study period

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