Document Detail

Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma.
MedLine Citation:
PMID:  20874458     Owner:  NLM     Status:  MEDLINE    
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.
Jorge F Maspero; Hendrik Nolte; Iván Chérrez-Ojeda;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-11-01
Journal Detail:
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:
Created Date:  2010-11-22     Completed Date:  2011-01-05     Revised Date:  2013-07-03    
Medline Journal Info:
Nlm Unique ID:  8106454     Medline TA:  J Asthma     Country:  England    
Other Details:
Languages:  eng     Pagination:  1106-15     Citation Subset:  IM    
Fundacion CIDEA, Allergy/Respiratory Research, Buenos Aires, Argentina.
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MeSH Terms
Administration, Inhalation
Anti-Inflammatory Agents / administration & dosage*,  adverse effects
Asthma / drug therapy*
Bronchodilator Agents / administration & dosage*,  adverse effects
Ethanolamines / administration & dosage*,  adverse effects
Hydrocortisone / blood
Intraocular Pressure
Metered Dose Inhalers
Pregnadienediols / administration & dosage*,  adverse effects
Single-Blind Method
Reg. No./Substance:
0/Anti-Inflammatory Agents; 0/Bronchodilator Agents; 0/Ethanolamines; 0/Pregnadienediols; 50-23-7/Hydrocortisone; 5ZZ84GCW8B/formoterol; 83919-23-7/mometasone furoate
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 /
Erratum In:
J Asthma. 2011 Feb;48(1):114

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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