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Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids.
Allergy Asthma Proc 2010 Jul-Aug; 31(4):269-79AA

Abstract

Asthma is a heterogeneous condition characterized by reduced lung function, chronic inflammation, and periodic asthma deteriorations. This study was performed to evaluate the effect of mometasone furoate (MF)/formoterol (F) combination, 200/10 microg, administered twice daily (b.i.d.) on asthma deteriorations and pulmonary function in patients with asthma uncontrolled on medium-dose inhaled corticosteroid (ICS). After 2- to 3-week open-label run-in with MF 200 microg b.i.d., patients (>or=12 years) were randomized to 26 weeks of treatment with MF/F 200/10 microg, MF 200 microg, F 10 microg, or placebo b.i.d. Coprimary end points were time to first asthma deterioration (MF/F versus F) and bronchodilation, assessed by the area under the curve of the change in forced expiratory volume in 1 second 0-12 hours (FEV(1) AUC(0-12h); MF/F versus MF). A total of 781 patients were randomized. Treatment with MF/F 200/10 microg reduced asthma deteriorations and clinically judged deteriorations (i.e., deterioration resulting in emergency treatment, hospitalization, or treatment with additional excluded asthma medication [i.e., systemic corticosteroids]). The proportion of patients experiencing asthma deteriorations was MF/F, 30.4%; MF, 33.9%; F, 54.0%; placebo, 55.6% (p < 0.001, MF/F versus F and placebo). There was a sixfold reduction in clinically judged deteriorations with MF/F versus F and placebo (p < 0.001). Lung function improved more rapidly with MF/F than MF and placebo. Mean change from baseline FEV(1) AUC(0-12h) at week 12 was MF/F, 11.7% versus MF, 5.7%; F, 8.5%; and placebo, 3.9% (p < 0.001). Treatment-related AEs were rare and similar across groups. Treatment with MF/F 200/10 microg was effective in reducing the risk of asthma deteriorations. MF/F was safe and provided rapid and sustained bronchodilation in patients with asthma.

Authors+Show Affiliations

Asthma and Allergy Associates and Research Center, Colorado Springs, Colorado 80907, USA. drrnathan@aol.comNo 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

20678306

Citation

Nathan, Robert A., et al. "Twenty-six-week Efficacy and Safety Study of Mometasone Furoate/formoterol 200/10 Microg Combination Treatment in Patients With Persistent Asthma Previously Receiving Medium-dose Inhaled Corticosteroids." Allergy and Asthma Proceedings, vol. 31, no. 4, 2010, pp. 269-79.
Nathan RA, Nolte H, Pearlman DS, et al. Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids. Allergy Asthma Proc. 2010;31(4):269-79.
Nathan, R. A., Nolte, H., & Pearlman, D. S. (2010). Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids. Allergy and Asthma Proceedings, 31(4), pp. 269-79. doi:10.2500/aap.2010.31.3364.
Nathan RA, et al. Twenty-six-week Efficacy and Safety Study of Mometasone Furoate/formoterol 200/10 Microg Combination Treatment in Patients With Persistent Asthma Previously Receiving Medium-dose Inhaled Corticosteroids. Allergy Asthma Proc. 2010;31(4):269-79. PubMed PMID: 20678306.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids. AU - Nathan,Robert A, AU - Nolte,Hendrik, AU - Pearlman,David S, AU - ,, Y1 - 2010/07/30/ PY - 2010/8/4/entrez PY - 2010/8/4/pubmed PY - 2011/6/15/medline SP - 269 EP - 79 JF - Allergy and asthma proceedings JO - Allergy Asthma Proc VL - 31 IS - 4 N2 - Asthma is a heterogeneous condition characterized by reduced lung function, chronic inflammation, and periodic asthma deteriorations. This study was performed to evaluate the effect of mometasone furoate (MF)/formoterol (F) combination, 200/10 microg, administered twice daily (b.i.d.) on asthma deteriorations and pulmonary function in patients with asthma uncontrolled on medium-dose inhaled corticosteroid (ICS). After 2- to 3-week open-label run-in with MF 200 microg b.i.d., patients (>or=12 years) were randomized to 26 weeks of treatment with MF/F 200/10 microg, MF 200 microg, F 10 microg, or placebo b.i.d. Coprimary end points were time to first asthma deterioration (MF/F versus F) and bronchodilation, assessed by the area under the curve of the change in forced expiratory volume in 1 second 0-12 hours (FEV(1) AUC(0-12h); MF/F versus MF). A total of 781 patients were randomized. Treatment with MF/F 200/10 microg reduced asthma deteriorations and clinically judged deteriorations (i.e., deterioration resulting in emergency treatment, hospitalization, or treatment with additional excluded asthma medication [i.e., systemic corticosteroids]). The proportion of patients experiencing asthma deteriorations was MF/F, 30.4%; MF, 33.9%; F, 54.0%; placebo, 55.6% (p < 0.001, MF/F versus F and placebo). There was a sixfold reduction in clinically judged deteriorations with MF/F versus F and placebo (p < 0.001). Lung function improved more rapidly with MF/F than MF and placebo. Mean change from baseline FEV(1) AUC(0-12h) at week 12 was MF/F, 11.7% versus MF, 5.7%; F, 8.5%; and placebo, 3.9% (p < 0.001). Treatment-related AEs were rare and similar across groups. Treatment with MF/F 200/10 microg was effective in reducing the risk of asthma deteriorations. MF/F was safe and provided rapid and sustained bronchodilation in patients with asthma. SN - 1539-6304 UR - https://www.unboundmedicine.com/medline/citation/20678306/Twenty-six-week_efficacy_and_safety_study_of_mometasone_furoate/formoterol_200/10_microg_combination_treatment_in_patients_with_persistent_asthma_previously_receiving_medium-dose_inhaled_corticosteroids L2 - https://www.ingentaconnect.com/openurl?genre=article&amp;issn=1088-5412&amp;volume=31&amp;issue=4&amp;spage=269&amp;aulast=Nathan DB - PRIME DP - Unbound Medicine ER -