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Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma.

Maspero JF, Nolte H, Chérrez-Ojeda I, P04139 Study Gro - J Asthma (2010)

Bottom Line: Additional safety evaluations included plasma cortisol 24-hour area under the curve (AUC(0-24 h)) and ocular changes.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.

View Article: PubMed Central - PubMed

Affiliation: Fundacion CIDEA, Allergy/Respiratory Research, Buenos Aires, Argentina. maspero@ciudad.com.ar

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.

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Related in: MedlinePlus

Improvement in mean 24-hour total asthma symptom scores. Total asthma symptom scores are the sum of wheezing, coughing, and difficulty breathing scores, based on a scale of 0 (none) to 3 (severe). FP/S, fluticasone propionate/salmeterol; MF/F, mometasone furoate/formoterol.
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fig3: Improvement in mean 24-hour total asthma symptom scores. Total asthma symptom scores are the sum of wheezing, coughing, and difficulty breathing scores, based on a scale of 0 (none) to 3 (severe). FP/S, fluticasone propionate/salmeterol; MF/F, mometasone furoate/formoterol.

Mentions: Patient-assessed mean 24-hour total asthma symptom scores were lower (i.e., improved) in the medium-dose stratum (MF/F 200/10 μg, 1.29; FP/S 250/50 μg, 1.18) than in the high-dose stratum (MF/F 400/10 μg, 1.60; FP/S 500/50 μg, 1.82) at baseline. All scores in all treatment groups were lower at each monthly visit during the study and at study endpoint compared with baseline (Figure 3). Absolute changes from baseline in mean 24-hour total asthma symptom scores at study end-point represented improvement of 63.9% with MF/F 200/10 μg, 45.0% with FP/S 250/50 μg, 34.5% with MF/F 400/10 μg, and 48.2% with FP/S 500/50 μg. Furthermore, proportion of asthma-free days and nights (i.e., no SABA use, no asthma symptoms, 24-hour PEF variability less than 20% of baseline, no unscheduled visits to a medical facility, and no nocturnal awakening) increased by 3.6-fold with MF/F 200/10 μg, 4.3-fold with FP/S 250/50 μg, 9.3-fold with MF/F 400/10 μg, and 3.4-fold with FP/S 500/50 μg. The proportions of days and nights free of SABA use increased by 47%, 65%, 78%, and 100% in the MF/F 200/10 μg, FP/S 250/50 μg, MF/F 400/10 μg, and FP/S 500/50 μg treatment groups, respectively.


Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma.

Maspero JF, Nolte H, Chérrez-Ojeda I, P04139 Study Gro - J Asthma (2010)

Improvement in mean 24-hour total asthma symptom scores. Total asthma symptom scores are the sum of wheezing, coughing, and difficulty breathing scores, based on a scale of 0 (none) to 3 (severe). FP/S, fluticasone propionate/salmeterol; MF/F, mometasone furoate/formoterol.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC2993043&req=5

fig3: Improvement in mean 24-hour total asthma symptom scores. Total asthma symptom scores are the sum of wheezing, coughing, and difficulty breathing scores, based on a scale of 0 (none) to 3 (severe). FP/S, fluticasone propionate/salmeterol; MF/F, mometasone furoate/formoterol.
Mentions: Patient-assessed mean 24-hour total asthma symptom scores were lower (i.e., improved) in the medium-dose stratum (MF/F 200/10 μg, 1.29; FP/S 250/50 μg, 1.18) than in the high-dose stratum (MF/F 400/10 μg, 1.60; FP/S 500/50 μg, 1.82) at baseline. All scores in all treatment groups were lower at each monthly visit during the study and at study endpoint compared with baseline (Figure 3). Absolute changes from baseline in mean 24-hour total asthma symptom scores at study end-point represented improvement of 63.9% with MF/F 200/10 μg, 45.0% with FP/S 250/50 μg, 34.5% with MF/F 400/10 μg, and 48.2% with FP/S 500/50 μg. Furthermore, proportion of asthma-free days and nights (i.e., no SABA use, no asthma symptoms, 24-hour PEF variability less than 20% of baseline, no unscheduled visits to a medical facility, and no nocturnal awakening) increased by 3.6-fold with MF/F 200/10 μg, 4.3-fold with FP/S 250/50 μg, 9.3-fold with MF/F 400/10 μg, and 3.4-fold with FP/S 500/50 μg. The proportions of days and nights free of SABA use increased by 47%, 65%, 78%, and 100% in the MF/F 200/10 μg, FP/S 250/50 μg, MF/F 400/10 μg, and FP/S 500/50 μg treatment groups, respectively.

Bottom Line: Additional safety evaluations included plasma cortisol 24-hour area under the curve (AUC(0-24 h)) and ocular changes.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.

View Article: PubMed Central - PubMed

Affiliation: Fundacion CIDEA, Allergy/Respiratory Research, Buenos Aires, Argentina. maspero@ciudad.com.ar

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.

Show MeSH
Related in: MedlinePlus