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

Effects of mometasone furoate/formoterol fumarate fixed-dose combination formulation on chronic obstructive pulmonary disease (COPD): results from a 52-week Phase III trial in subjects with moderate-to-very severe COPD

Dennis E Doherty1 Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky, Lexington, KYCorrespondence[email protected]
,
Donald P Tashkin2 David Geffen School of Medicine at UCLA, Los Angeles, CA
,
Edward Kerwin3 Clinical Research Institute of Southern Oregon, Medford, OR
,
Barbara A Knorr4 Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA
,
Tulin Shekar4 Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA
,
Sibabrata Banerjee4 Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA
&
Heribert Staudinger4 Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA
 show all
Pages 57-71 | Published online: 03 Feb 2012

Figures & data

Figure 1 Subject disposition.

Notes: Total doses were delivered after two inhalations BID of the following actuated doses: MF/F 200/5 μg, MF/F 100/5 μg, MF 200 μg, F 5 μg, or placebo.
Abbreviations: AE, adverse event; BID, twice daily; F, formoterol; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixed-dose combination formulation.
Figure 1 Subject disposition.

Table 1 Subject demographics and clinical characteristics

Figure 2 FEV1 AUC0–12 h at week 13 endpoint (LOCF).

Abbreviations: AUC0–12 h, area under the curve from 0 to 12 hours post-dose; BID, twice daily; FEV1, forced expiratory volume in 1 second; LOCF, last observation carried forward; F, formoterol; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixed-dose combination formulation.
Figure 2 FEV1 AUC0–12 h at week 13 endpoint (LOCF).

Figure 3 Serial FEV1 post-dose at day 1 (A) and week 26 (B).

Notes: Significantly greater increases in FEV1 occurred with both MF/F treatments compared with MF at all time points on day 1 (P < 0.001), as well as week 26 (P ≤ 0.035). Compared with F 10 μg, MF/F 400/10 μg had significantly greater increases in FEV1 at all time points on week 26 (P ≤ 0.016), whereas MF/F 200/10 μg had significantly greater increases versus F only at the 4 and 8 hour post-dose time points (P ≤ 0.022).
Abbreviations: BID, twice daily; FEV1, forced expiratory volume in 1 second; F, formoterol; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixed-dose combination formulation.
Figure 3 Serial FEV1 post-dose at day 1 (A) and week 26 (B).

Figure 4 AM pre-dose (trough) FEV1 at week 13 endpoint.

Abbreviations: AM, morning; BID, twice daily; FEV1, forced expiratory volume in 1 second; F, formoterol; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixed-dose combination formulation.
Figure 4 AM pre-dose (trough) FEV1 at week 13 endpoint.

Figure 5 SGRQ total score change from baseline at week 26 endpoint.

Notes: Compared with placebo, significantly greater improvements in SGRQ total scores occurred with MF/F 400/10 μg (P = 0.020) and MF 400 μg (P = 0.023), as well as with MF/F 200/10 μg. The difference between MF/F 200/10 μg and F 10 μg was also significant (P = 0.020) at the week 26 endpoint.
Abbreviations: BID, twice daily; SGRQ, St George’s Respiratory Questionnaire; FEV1, forced expiratory volume in 1 second; F, formoterol; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixed-dose combination formulation.
Figure 5 SGRQ total score change from baseline at week 26 endpoint.

Figure 6 Time to first moderate or severe exacerbation over the 26-week treatment period.

Notes: *P < 0.001 versus placebo; †P = 0.027 versus placebo; ‡P = 0.003 versus placebo.
Abbreviations: F, formoterol; MF, mometasone furoate; MF/F, mometasone furoate/formoterol fixed-dose combination formulation.
Figure 6 Time to first moderate or severe exacerbation over the 26-week treatment period.

Table 2 Summary of treatment-emergent adverse events

Table 3 Treatment-emergent adverse events in ≥2% of subjects in any treatment group

Table 4 Treatment-emergent adverse events in ≥2% of subjects in any active treatment group over the safety extension

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