Inhaled Mometasone Furoate Improved Efficacy in Paediatric Asthma Patients Independent of Previous ICS Therapy: Presented at PAS
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Inhaled Mometasone Furoate Improved Efficacy in Paediatric Asthma Patients Independent of Previous ICS Therapy: Presented at PAS

By Sandra Distelhorst

VANCOUVER -- May 7, 2010 -- Control of asthma in paediatric patients was improved with use of inhaled mometasone furoate, according to a study presented here at the 2010 Pediatric Academic Societies (PAS) Annual Meeting.

Inhaled corticosteroids (ICSs) are the preferred treatment for initiating daily therapy for long-term control of mild to moderate asthma in children of all ages. Adjustments of medication are often needed over time to maintain consistent control of asthma symptoms. When patients change asthma therapy, asthma control must be maintained or improved after the switch.

Henry Milgrom, MD, National Jewish Health, Denver, Colorado, presented the results on May 2 of 3 randomised controlled phase 3 trials that evaluated mometasone furoate dry powder inhaler (MF-DPI) treatment versus placebo in children with persistent mild to moderate asthma. MF-DPI was administered once daily at bedtime.

The post hoc analysis included 902 children and examined the consistency of MF effects across different previous ICS at endpoint and over time. At baseline, patients switched directly (no washout) to inhaled MF 110 or 220 mcg/day or placebo from previous ICS therapy with beclomethasone, budesonide, fluticasone, flunisolide, or triamcinolone. Each trial was 12 weeks long, but they differed in some parameters, such as washout period before switching medications.

All the trials found that MF-DPI improved clinical efficacy and safety in children aged 4-11 years.

The primary efficacy variable in the studies was the percentage of predicted forced expiratory volume in 1 second (%FEV1); other pulmonary function variables and response to therapy were also evaluated. Analysis of variance with treatment, study, previous ICS, and previous ICS-by-treatment interactions was fitted for each variable on day 4; weeks 1, 2, 4, 8, and 12; and at endpoint, with significance of interactions at P < .05.

The 2 most common ICSs used were beclomethasone (42%) and fluticasone (31%). The %FEV1 increased significantly in all MF groups at endpoint (P < .001 vs placebo), with increases ranging from 4.6 to 6.3 percentage points with MF 110 mcg/day and from 5.0 to 6.8 percentage points with MF 220 mcg/day. No significant differential treatment response was seen among previous ICSs at endpoint or over time.

The researchers concluded that regardless of previous ICS therapy and based on the clinical study variables, asthma control was improved compared with placebo at endpoint and all time points in children who switched to inhaled MF-DPI from a previous ICS.

Funding for this study was provided by Schering Corp., a Division of Merck & Co.

[Presentation title: Inhaled Mometasone Furoate Improved Efficacy in Pediatric Asthma Patients Regardless of Previous Inhaled Corticosteroid Therapy: Pooled Data From the Clinical Development Program. Abstract 2834.35]



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