By Crina Frincu-Mallos, PhD
WASHINGTON, DC -- October 22, 2009 -- Mometasone furoate (MF-DPI), an inhaled corticosteroid (ICS) administered via a dry powder inhaler, safely controls asthma in children switched from other corticosteroid therapies, such as fluticasone propionate or beclomethasone dipropionate, researchers reported here at the 2009 American Academy of Pediatrics (AAP) National Conference & Exhibition (NCE).
"Asthma control was maintained by MF-DPI 110 mcg administered once daily after switching from previous inhaled corticosteroid therapy," according to data compiled from 3 clinical studies involving children with persistent asthma, said Eduardo A. Urdaneta, MD, Schering-Plough, Kenilworth, New Jersey.
It is important that switching from 1 ICS to another does not impair asthma control, as defined by lung function, symptoms, and albuterol use, in children with asthma, explained the study researchers.
Dr. Urdaneta reported the data here October 19, on behalf of collaborators from Allergy & Asthma Specialists Medical Group and Research Center, Huntington Beach, California, and Allergy Associates Research Center LLC, Portland, Oregon.
"Inhaled corticosteroids are the most effective controller medications for mild persistent asthma," he said, adding that MF-DPI is "the only inhaled corticosteroid in the United States currently approved for once-daily use in children."
To elucidate if and how prior ICS use impacts the efficacy of MF-DPI, the researchers conducted a retrospective analysis of the safety and efficacy outcomes accrued from three 12-week clinical trials conducted at their institutions. All children (N = 902; aged 4-11 years) participating in these randomised, placebo-controlled, double-blinded trials were diagnosed with mild persistent asthma.
All children received corticosteroid therapy for at least 24 days before screening, being administered either total daily doses of 176 mcg fluticasone propionate or 300 mcg beclomethasone dipropionate for at least 2 weeks before screening, when they were directly switched to oncedaily MF-DPI 100 mcg or placebo (no washout period). The investigators evaluated changes in lung function, asthma symptoms, and albuterol use.
Asthma control was not only maintained, but improved in patients switched to MF-DPI, compared with placebo, noted Dr. Urdaneta. In addition, those treated with MF-DPI reported decreased use of rescue albuterol by the first week, and these reductions were sustained throughout treatment.
To evaluate the lung function, the investigators analysed forced expiratory volume in 1 second (FEV1) at the first post-baseline measurement (day 4) and found that the predicted FEV1 value improved by 7% or more after 4 days of treatment with MF-DPI.
"Significant improvements began as early as week 2 with MF-DPI once daily compared with placebo [P < .023]," remarked Dr. Urdaneta, adding that the improvements "were generally maintained throughout the 12-week study periods."
The study received funding from Schering-Plough, the maker of MF-DPI.
[Presentation title: Maintenance of Asthma Control With Once-Daily Mometasone Furoate in Children Switched From Previous Inhaled Corticosteroid Therapy. Abstract 6321]
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