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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 Full Text
International Journal of COPD, 02/03/2012
Clinical Article
Doherty DE et al. – Mometasone furoate/formoterol fumarate (MF/F) treatments improved lung function and respiratory health status, reduced exacerbations, and were well tolerated in subjects with moderate–to–very severe chronic obstructive pulmonary disease (COPD).
Methods- This multicenter, double–blind, placebo–controlled trial had a 26–week treatment period and a 26–week safety extension.
- Subjects (n = 1196), at least 40 years old, were current or ex–smokers randomized to twice–daily inhaled MF/F 400/10 µg, MF/F 200/10 µg, MF 400 µg, F 10 µg, or placebo.
- The trial’s co–primary endpoints were mean changes from baseline, as area under the curve (AUC), in forced expiratory volume (FEV1) over 0–12 hours (AUC0–12 h FEV1) with MF/F versus MF, and in morning (AM) pre–dose (trough) FEV1 with MF/F versus F after 13 weeks of treatment.
- Key secondary endpoints were the effects of MF/F on respiratory health status using the Saint George’s Respiratory Questionnaire (SGRQ), symptom–free nights, partly stable COPD at 26 weeks, and time to first COPD exacerbation.
- The largest improvements in AUC0–12 h FEV1 were observed with MF/F 400/10 µg and MF/F 200/10 µg.
- Serial spirometry results demonstrated that bronchodilator effects with MF/F occurred rapidly (within 5 minutes), persisted for 12 hours after dosing, and were sustained over the 26–week treatment period.
- Similar findings were observed for AM pre–dose FEV1, for which effects were further investigated, excluding subjects whose AM FEV1 data were incorrectly collected after 2 days from the last dose of study treatment.
- Improvements in SGRQ scores surpassed the minimum clinically important difference of more than four units with both MF/F treatments.
- At 26 weeks, no notable between–treatment differences in the occurrence and nature of adverse events (AEs) were reported.
- No unexpected AEs were observed.
- Overall, 90 subjects reported AEs considered to be treatment–related, the most common of which were lenticular opacities, dysphonia, and oral candidiasis.
