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Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma.
J Asthma 2010; 47(10):1106-15JA

Abstract

OBJECTIVE

The combination of inhaled corticosteroid (ICS) and long-acting β₂-agonist is recommended for treatment of patients with persistent asthma inadequately controlled on ICS monotherapy. This study was conducted to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) administered through metered-dose inhaler (MDI) in patients with persistent asthma previously on medium- to high-dose ICS.

METHODS

This was a 52-week, randomized, multicenter, parallel-group, open-label, evaluator-blinded study. At baseline, 404 patients (aged ≥12 years) were stratified according to their previous ICS dose (medium or high), then randomized 2:1 to receive twice-daily treatment of MF/F (200/10 or 400/10 μg) or fluticasone propionate/salmeterol (FP/S; 250/50 or 500/50 μg). The primary endpoint was the number and percentage of patients reporting any adverse event (AE). Additional safety evaluations included plasma cortisol 24-hour area under the curve (AUC(0-24 h)) and ocular changes. Pulmonary function, asthma symptoms, and use of rescue medication were monitored.

RESULTS

The incidence of ≥1 treatment-emergent AE was similar across treatment groups (MF/F 200/10 μg, 77.3% [n= 109]; FP/S 250/50 μg, 82.4% [n= 56]; MF/F 400/10 μg, 79.2% [n= 103]; FP/S 500/50 μg, 76.9% [n= 50]). Rates of treatment-related AEs were also similar across treatment groups (MF/F 200/10 μg, 28.4%; FP/S 250/50 μg, 23.5%; MF/F 400/10 μg, 23.1%; FP/S 500/50 μg, 20.0%). Headache (3.7%) and dysphonia (2.7%) were the most common treatment-related AEs overall. The nature and frequency of AEs and the decreases in plasma cortisol AUC(0-24 h) observed with MF/F treatment were similar to those observed with FP/S treatment. Ocular events were rare (2-6% overall incidence among treatment groups); in particular, no posterior subcapsular cataracts were reported. Only three patients discontinued the study because of treatment-related ocular AEs (two for lens disorders in the MF/F 400/10 μg group; one for reduced visual acuity in the FP/S 250/50 μg group) and no asthma-related deaths occurred. Furthermore, MF/F showed numerical improvement in lung function and clinical benefits by reducing asthma symptoms and rescue medication use.

CONCLUSIONS

One-year treatment with the new combination therapies - twice-daily MF/F-MDI 200/10 and 400/10 μg - is safe and well tolerated in patients with persistent asthma.

Authors+Show Affiliations

Fundacion CIDEA, Allergy/Respiratory Research, Buenos Aires, Argentina. maspero@ciudad.com.arNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

20874458

Citation

Maspero, Jorge F., et al. "Long-term Safety of Mometasone Furoate/formoterol Combination for Treatment of Patients With Persistent Asthma." The Journal of Asthma : Official Journal of the Association for the Care of Asthma, vol. 47, no. 10, 2010, pp. 1106-15.
Maspero JF, Nolte H, Chérrez-Ojeda I, et al. Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma. J Asthma. 2010;47(10):1106-15.
Maspero, J. F., Nolte, H., & Chérrez-Ojeda, I. (2010). Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma. The Journal of Asthma : Official Journal of the Association for the Care of Asthma, 47(10), pp. 1106-15. doi:10.3109/02770903.2010.514634.
Maspero JF, et al. Long-term Safety of Mometasone Furoate/formoterol Combination for Treatment of Patients With Persistent Asthma. J Asthma. 2010;47(10):1106-15. PubMed PMID: 20874458.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma. AU - Maspero,Jorge F, AU - Nolte,Hendrik, AU - Chérrez-Ojeda,Iván, AU - ,, Y1 - 2010/11/01/ PY - 2010/9/30/entrez PY - 2010/9/30/pubmed PY - 2011/1/6/medline SP - 1106 EP - 15 JF - The Journal of asthma : official journal of the Association for the Care of Asthma JO - J Asthma VL - 47 IS - 10 N2 - OBJECTIVE: The combination of inhaled corticosteroid (ICS) and long-acting β₂-agonist is recommended for treatment of patients with persistent asthma inadequately controlled on ICS monotherapy. This study was conducted to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) administered through metered-dose inhaler (MDI) in patients with persistent asthma previously on medium- to high-dose ICS. METHODS: This was a 52-week, randomized, multicenter, parallel-group, open-label, evaluator-blinded study. At baseline, 404 patients (aged ≥12 years) were stratified according to their previous ICS dose (medium or high), then randomized 2:1 to receive twice-daily treatment of MF/F (200/10 or 400/10 μg) or fluticasone propionate/salmeterol (FP/S; 250/50 or 500/50 μg). The primary endpoint was the number and percentage of patients reporting any adverse event (AE). Additional safety evaluations included plasma cortisol 24-hour area under the curve (AUC(0-24 h)) and ocular changes. Pulmonary function, asthma symptoms, and use of rescue medication were monitored. RESULTS: The incidence of ≥1 treatment-emergent AE was similar across treatment groups (MF/F 200/10 μg, 77.3% [n= 109]; FP/S 250/50 μg, 82.4% [n= 56]; MF/F 400/10 μg, 79.2% [n= 103]; FP/S 500/50 μg, 76.9% [n= 50]). Rates of treatment-related AEs were also similar across treatment groups (MF/F 200/10 μg, 28.4%; FP/S 250/50 μg, 23.5%; MF/F 400/10 μg, 23.1%; FP/S 500/50 μg, 20.0%). Headache (3.7%) and dysphonia (2.7%) were the most common treatment-related AEs overall. The nature and frequency of AEs and the decreases in plasma cortisol AUC(0-24 h) observed with MF/F treatment were similar to those observed with FP/S treatment. Ocular events were rare (2-6% overall incidence among treatment groups); in particular, no posterior subcapsular cataracts were reported. Only three patients discontinued the study because of treatment-related ocular AEs (two for lens disorders in the MF/F 400/10 μg group; one for reduced visual acuity in the FP/S 250/50 μg group) and no asthma-related deaths occurred. Furthermore, MF/F showed numerical improvement in lung function and clinical benefits by reducing asthma symptoms and rescue medication use. CONCLUSIONS: One-year treatment with the new combination therapies - twice-daily MF/F-MDI 200/10 and 400/10 μg - is safe and well tolerated in patients with persistent asthma. SN - 1532-4303 UR - https://www.unboundmedicine.com/medline/citation/20874458/Long_term_safety_of_mometasone_furoate/formoterol_combination_for_treatment_of_patients_with_persistent_asthma_ L2 - http://www.tandfonline.com/doi/full/10.3109/02770903.2010.514634 DB - PRIME DP - Unbound Medicine ER -