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Twelve-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg and 400/10 microg combination treatments in patients with persistent asthma previously receiving high-dose inhaled corticosteroids.
Allergy Asthma Proc 2010 Jul-Aug; 31(4):280-9AA

Abstract

A significant unmet medical need exists in patients with uncontrolled asthma. The purpose of this study was to evaluate the efficacy and safety of mometasone furoate/formoterol (MF/F) 400/10 microg versus MF 400 microg administered twice-daily (b.i.d.) via metered-dose inhaler in patients with asthma uncontrolled on high-dose inhaled corticosteroids (ICS). In a 12-week, randomized, multicenter, double-blind, parallel-group study, patients (>or=12 years of age) were randomized to MF/F 200/10 microg, MF/F 400/10 microg, or MF 400 microg, b.i.d. after a 2- to 3-week open-label run in with MF 400 microg b.i.d. The primary end point was mean change in area under the curve from 0 to 12 hours in forced expiratory volume in 1 second (FEV(1) AUC(0-12h)) from baseline to week 12 for MF/F 400/10 microg versus MF 400 microg. Effects of MF/F on asthma control and symptoms were evaluated and adverse events recorded. Seven hundred twenty-eight patients were randomized. Significant improvement from baseline to week 12 occurred for mean change in FEV(1) AUC(0-12h) with MF/F 400/10 microg (4.19 L x hour) versus MF 400 microg (2.04 L x hour; p < 0.001). Both MF/F doses resulted in rapid (5 minutes) and sustained improvement in lung function throughout 12 weeks. Both MF/F doses were superior to MF in improving asthma control and reducing nocturnal awakenings due to asthma requiring short-acting beta(2)-agonist use. All treatments were well tolerated. Asthma patients who were poorly controlled on high-dose ICS experienced significant improvement in asthma control, lung function, and symptoms when treated with MF/F compared with MF.

Authors+Show Affiliations

Allergy and Asthma Specialists Medical Group, Huntington Beach, Californai 92647, USA. sfw@ocallergy.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

20687982

Citation

Weinstein, Steven F., et al. "Twelve-week Efficacy and Safety Study of Mometasone Furoate/formoterol 200/10 Microg and 400/10 Microg Combination Treatments in Patients With Persistent Asthma Previously Receiving High-dose Inhaled Corticosteroids." Allergy and Asthma Proceedings, vol. 31, no. 4, 2010, pp. 280-9.
Weinstein SF, Corren J, Murphy K, et al. Twelve-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg and 400/10 microg combination treatments in patients with persistent asthma previously receiving high-dose inhaled corticosteroids. Allergy Asthma Proc. 2010;31(4):280-9.
Weinstein, S. F., Corren, J., Murphy, K., Nolte, H., & White, M. (2010). Twelve-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg and 400/10 microg combination treatments in patients with persistent asthma previously receiving high-dose inhaled corticosteroids. Allergy and Asthma Proceedings, 31(4), pp. 280-9. doi:10.2500/aap.2010.31.3381.
Weinstein SF, et al. Twelve-week Efficacy and Safety Study of Mometasone Furoate/formoterol 200/10 Microg and 400/10 Microg Combination Treatments in Patients With Persistent Asthma Previously Receiving High-dose Inhaled Corticosteroids. Allergy Asthma Proc. 2010;31(4):280-9. PubMed PMID: 20687982.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Twelve-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg and 400/10 microg combination treatments in patients with persistent asthma previously receiving high-dose inhaled corticosteroids. AU - Weinstein,Steven F, AU - Corren,Jonathan, AU - Murphy,Kevin, AU - Nolte,Hendrik, AU - White,Martha, AU - ,, Y1 - 2010/08/03/ PY - 2010/8/7/entrez PY - 2010/8/7/pubmed PY - 2011/6/15/medline SP - 280 EP - 9 JF - Allergy and asthma proceedings JO - Allergy Asthma Proc VL - 31 IS - 4 N2 - A significant unmet medical need exists in patients with uncontrolled asthma. The purpose of this study was to evaluate the efficacy and safety of mometasone furoate/formoterol (MF/F) 400/10 microg versus MF 400 microg administered twice-daily (b.i.d.) via metered-dose inhaler in patients with asthma uncontrolled on high-dose inhaled corticosteroids (ICS). In a 12-week, randomized, multicenter, double-blind, parallel-group study, patients (>or=12 years of age) were randomized to MF/F 200/10 microg, MF/F 400/10 microg, or MF 400 microg, b.i.d. after a 2- to 3-week open-label run in with MF 400 microg b.i.d. The primary end point was mean change in area under the curve from 0 to 12 hours in forced expiratory volume in 1 second (FEV(1) AUC(0-12h)) from baseline to week 12 for MF/F 400/10 microg versus MF 400 microg. Effects of MF/F on asthma control and symptoms were evaluated and adverse events recorded. Seven hundred twenty-eight patients were randomized. Significant improvement from baseline to week 12 occurred for mean change in FEV(1) AUC(0-12h) with MF/F 400/10 microg (4.19 L x hour) versus MF 400 microg (2.04 L x hour; p < 0.001). Both MF/F doses resulted in rapid (5 minutes) and sustained improvement in lung function throughout 12 weeks. Both MF/F doses were superior to MF in improving asthma control and reducing nocturnal awakenings due to asthma requiring short-acting beta(2)-agonist use. All treatments were well tolerated. Asthma patients who were poorly controlled on high-dose ICS experienced significant improvement in asthma control, lung function, and symptoms when treated with MF/F compared with MF. SN - 1539-6304 UR - https://www.unboundmedicine.com/medline/citation/20687982/Twelve-week_efficacy_and_safety_study_of_mometasone_furoate/formoterol_200/10_microg_and_400/10_microg_combination_treatments_in_patients_with_persistent_asthma_previously_receiving_high-dose_inhaled_corticosteroids L2 - https://www.ingentaconnect.com/openurl?genre=article&amp;issn=1088-5412&amp;volume=31&amp;issue=4&amp;spage=280&amp;aulast=Weinstein DB - PRIME DP - Unbound Medicine ER -