Inhaled Mometasone Furoate Improved Efficacy in Pediatric Asthma Patients Regardless of Previous Inhaled Corticosteroid Therapy: Pooled Data From the

Background: Background: When patients change asthma controller therapy, it is important for asthma control to be maintained or improved after the switch. The clinical development program for inhaled mometasone furoate administered via a dry powder inhaler (MF-DPI) included three 12-week, randomized, placebo-controlled trials in 902 children aged 4-11 years. At baseline, subjects switched directly (no washout) to inhaled MF-DPI 110 or 220 μg/d or placebo from previous inhaled corticosteroid (ICS) therapy with beclomethasone, budesonide, fluticasone, flunisolide, or triamcinolone.

We examined the consistency of MF-DPI effects across different previous ICS at end point and over time by conducting a post hoc analysis.

 

Methods: Methods: The primary efficacy variable 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, 12; and end point with significance of interactions at P<.05.

 

Results: Results: The 2 most common previous ICS were beclomethasone and fluticasone (42.4% and 31.3% of subjects, respectively). The % FEV1 increased significantly in all MF groups at end point (P<.001 vs placebo), with increases ranging from 4.6-6.3 percentage points with MF-DPI 110 μg/d and from 5.0-6.8 percentage points with MF-DPI 220 μg/d. There was no significant differential treatment response among previous ICS at end point or over time.

 

Conclusion: Conclusions: Regardless of previous ICS therapy and based on the clinical study variables, asthma control was improved compared with placebo at end point and all time points in children who switched to inhaled MF-DPI from previous ICS.