Tags

Type your tag names separated by a space and hit enter

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.

Abstract

BACKGROUND

A clinical trial 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) investigated the efficacy and safety of a fixed-dose combination of MF/F.

METHODS

This multicenter, double-blind, placebo-controlled trial had a 26-week treatment period and a 26-week safety extension. Subjects (n = 1055; ≥40 years) were current or ex- smokers randomized to twice-daily treatment with inhaled MF/F 400/10 μg, MF/F 200/10 μg, MF 400 μg, F 10 μg, or placebo. The coprimary endpoints of the trial were mean changes from baseline in forced expiratory volume in 1 second (FEV(1)) over 0-12 hours (AUC(0-12) FEV(1)) with MF/F versus MF, and in morning predose FEV(1) with MF/F versus F. Key secondary endpoints were quality of life (Saint George's Respiratory Questionnaire [SGRQ]), symptom-free nights, and partly stable COPD at 26 weeks, as well as time to first COPD exacerbation.

RESULTS

Significant improvements in FEV(1) AUC(0-12) occurred at endpoint with MF/F 400/10 and MF/F 200/10 versus MF 400 (P ≤ 0.007). Significant bronchodilation occurred in 5 minutes with MF/F, and serial spirometry demonstrated sustained FEV(1) improvements with MF/F over the treatment period. Significant improvements in morning predose FEV(1) occurred with both MF/F doses, and these effects were further investigated by excluding results for subjects whose morning FEV(1) data were collected >2 days after the last dose of study treatment. Improvements in SGRQ total scores surpassed the minimum clinically important difference of at least 4 units with MF/F 400/10. MF/F 400/10 significantly reduced the time-to-first COPD exacerbation. Similar proportions of subjects in all five treatment groups reported treatment-emergent adverse events. Rates of pneumonia were low (≤1.0%) across treatment groups.

CONCLUSION

MF/F 400/10 μg twice daily was shown to be an effective therapy for patients with moderate to very severe COPD, and both MF/F 400/10 μg twice daily and MF/F 200/10 μg twice daily were well tolerated.

Authors+Show Affiliations

David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA. dtashkin@mednet.ucla.eduNo affiliation info availableNo 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

22334768

Citation

Tashkin, Donald P., et al. "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." International Journal of Chronic Obstructive Pulmonary Disease, vol. 7, 2012, pp. 43-55.
Tashkin DP, Doherty DE, Kerwin E, et al. 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. Int J Chron Obstruct Pulmon Dis. 2012;7:43-55.
Tashkin, D. P., Doherty, D. E., Kerwin, E., Matiz-Bueno, C. E., Knorr, B., Shekar, T., ... Staudinger, H. (2012). 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. International Journal of Chronic Obstructive Pulmonary Disease, 7, pp. 43-55. doi:10.2147/COPD.S27319.
Tashkin DP, et al. 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. Int J Chron Obstruct Pulmon Dis. 2012;7:43-55. PubMed PMID: 22334768.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Tashkin,Donald P, AU - Doherty,Dennis E, AU - Kerwin,Edward, AU - Matiz-Bueno,Carlos E, AU - Knorr,Barbara, 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 - FEV1 KW - bronchodilator KW - chronic obstructive pulmonary disease KW - exacerbation KW - inhaled corticosteroid KW - spirometry SP - 43 EP - 55 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 7 N2 - BACKGROUND: A clinical trial 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) investigated the efficacy and safety of a fixed-dose combination of MF/F. METHODS: This multicenter, double-blind, placebo-controlled trial had a 26-week treatment period and a 26-week safety extension. Subjects (n = 1055; ≥40 years) were current or ex- smokers randomized to twice-daily treatment with inhaled MF/F 400/10 μg, MF/F 200/10 μg, MF 400 μg, F 10 μg, or placebo. The coprimary endpoints of the trial were mean changes from baseline in forced expiratory volume in 1 second (FEV(1)) over 0-12 hours (AUC(0-12) FEV(1)) with MF/F versus MF, and in morning predose FEV(1) with MF/F versus F. Key secondary endpoints were quality of life (Saint George's Respiratory Questionnaire [SGRQ]), symptom-free nights, and partly stable COPD at 26 weeks, as well as time to first COPD exacerbation. RESULTS: Significant improvements in FEV(1) AUC(0-12) occurred at endpoint with MF/F 400/10 and MF/F 200/10 versus MF 400 (P ≤ 0.007). Significant bronchodilation occurred in 5 minutes with MF/F, and serial spirometry demonstrated sustained FEV(1) improvements with MF/F over the treatment period. Significant improvements in morning predose FEV(1) occurred with both MF/F doses, and these effects were further investigated by excluding results for subjects whose morning FEV(1) data were collected >2 days after the last dose of study treatment. Improvements in SGRQ total scores surpassed the minimum clinically important difference of at least 4 units with MF/F 400/10. MF/F 400/10 significantly reduced the time-to-first COPD exacerbation. Similar proportions of subjects in all five treatment groups reported treatment-emergent adverse events. Rates of pneumonia were low (≤1.0%) across treatment groups. CONCLUSION: MF/F 400/10 μg twice daily was shown to be an effective therapy for patients with moderate to very severe COPD, and both MF/F 400/10 μg twice daily and MF/F 200/10 μg twice daily were well tolerated. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/22334768/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 L2 - https://dx.doi.org/10.2147/COPD.S27319 DB - PRIME DP - Unbound Medicine ER -