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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.

Abstract

RATIONALE

The purpose of this study was to investigate the clinical efficacy and safety of a fixed-dose combination of mometasone furoate/formoterol fumarate (MF/F) administered via a metered-dose inhaler 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 (FEV(1)) over 0-12 hours (AUC(0-12 h) FEV(1)) with MF/F versus MF, and in morning (AM) pre-dose (trough) FEV(1) 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.

RESULTS

The largest improvements in AUC(0-12 h) FEV(1) 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 FEV(1), for which effects were further investigated, excluding subjects whose AM FEV(1) 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.

DISCUSSION

In conclusion, MF/F treatments improved lung function and respiratory health status, reduced exacerbations, and were well tolerated in subjects with moderate-to-very severe COPD.

Authors+Show Affiliations

Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky, Lexington, KY 40536, USA. dedohe0@email.uky.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22334769

Citation

Doherty, Dennis E., et al. "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." International Journal of Chronic Obstructive Pulmonary Disease, vol. 7, 2012, pp. 57-71.
Doherty DE, Tashkin DP, Kerwin E, et al. 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. Int J Chron Obstruct Pulmon Dis. 2012;7:57-71.
Doherty, D. E., Tashkin, D. P., Kerwin, E., Knorr, B. A., Shekar, T., Banerjee, S., & Staudinger, H. (2012). 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. International Journal of Chronic Obstructive Pulmonary Disease, 7, pp. 57-71. doi:10.2147/COPD.S27320.
Doherty DE, et al. 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. Int J Chron Obstruct Pulmon Dis. 2012;7:57-71. PubMed PMID: 22334769.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Doherty,Dennis E, AU - Tashkin,Donald P, AU - Kerwin,Edward, AU - Knorr,Barbara A, AU - Shekar,Tulin, AU - Banerjee,Sibabrata, AU - Staudinger,Heribert, Y1 - 2012/02/03/ PY - 2012/2/16/entrez PY - 2012/2/16/pubmed PY - 2012/6/1/medline KW - COPD KW - FEV1 KW - bronchodilator KW - exacerbation KW - inhaled corticosteroid KW - spirometry SP - 57 EP - 71 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 7 N2 - RATIONALE: The purpose of this study was to investigate the clinical efficacy and safety of a fixed-dose combination of mometasone furoate/formoterol fumarate (MF/F) administered via a metered-dose inhaler 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 (FEV(1)) over 0-12 hours (AUC(0-12 h) FEV(1)) with MF/F versus MF, and in morning (AM) pre-dose (trough) FEV(1) 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. RESULTS: The largest improvements in AUC(0-12 h) FEV(1) 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 FEV(1), for which effects were further investigated, excluding subjects whose AM FEV(1) 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. DISCUSSION: In conclusion, MF/F treatments improved lung function and respiratory health status, reduced exacerbations, and were well tolerated in subjects with moderate-to-very severe COPD. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/22334769/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 L2 - https://dx.doi.org/10.2147/COPD.S27320 DB - PRIME DP - Unbound Medicine ER -