| Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma. | |
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MedLine Citation:
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PMID: 20874458 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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Jorge F Maspero; Hendrik Nolte; Iván Chérrez-Ojeda; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2010-11-01 |
Journal Detail:
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Title: The Journal of asthma : official journal of the Association for the Care of Asthma Volume: 47 ISSN: 1532-4303 ISO Abbreviation: J Asthma Publication Date: 2010 Dec |
Date Detail:
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Created Date: 2010-11-22 Completed Date: 2011-01-05 Revised Date: 2011-02-18 |
Medline Journal Info:
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Nlm Unique ID: 8106454 Medline TA: J Asthma Country: England |
Other Details:
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Languages: eng Pagination: 1106-15 Citation Subset: IM |
Affiliation:
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Fundacion CIDEA, Allergy/Respiratory Research, Buenos Aires, Argentina. maspero@ciudad.com.ar |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Inhalation Adult Anti-Inflammatory Agents / administration & dosage*, adverse effects Asthma / drug therapy* Bronchodilator Agents / administration & dosage*, adverse effects Cataract Ethanolamines / administration & dosage*, adverse effects Female Humans Hydrocortisone / blood Intraocular Pressure Male Metered Dose Inhalers Pregnadienediols / administration & dosage*, adverse effects Single-Blind Method Spirometry |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents; 0/Bronchodilator Agents; 0/Ethanolamines; 0/Pregnadienediols; 50-23-7/Hydrocortisone; 73573-87-2/formoterol; 83919-23-7/mometasone furoate |
| Investigator | |
Investigator/Affiliation:
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Enrique Casal / ; Hector Defranchi / ; Carlos G Di Bartolo / ; Alberto L Dolmann / ; Jose E Jares / ; Jorge F Maspero / ; Luisa B Rey / ; Ahahi Yanez / ; Carlos Bisbal / ; Susana Munoz / ; Tamara Soler / ; Eduardo Castro / ; Ivan Cherrez / ; Rene Cordova / ; Efrén Guerrero / ; Victor Chur / ; Edgar Contreras / ; Jeremias Guerra / ; Gerardo Martinez / ; Jesus J Moran-Ochoa / ; Chavira M Perez / ; Marco Camere / ; William Chavez / ; Octavio Cubas / ; Felix Efrain / ; Andres Pineiro / ; Danilo Salazar / |
| Comments/Corrections | |
Erratum In:
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J Asthma. 2011 Feb;48(1):114 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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