Source: DGNews  |  Posted 2 years ago

By Sandra Distelhorst

VANCOUVER -- May 7, 2010 -- Small airway function is significantly improved in children with asthma by use of mometasone furoate dry powder inhaler (MF-DPI), according to a study presented here at the 2010 Pediatric Academic Societies (PAS) Annual Meeting.

The clinical effect of small airway inflammation in asthma is not well understood, said Michael Noonan, MD, Allergy Associates Research Center, Portland, Oregon, on May 2. However, associations with nocturnal asthma symptoms, exacerbations, and airway hyperresponsiveness have been demonstrated in some studies. One measure of the effect of asthma treatment on small airway function is the change in forced expiratory flow between 25% and 75% of vital capacity (FEF_25%-75%) after treatment.

The study analysed FEF_25%-75% as a secondary variable in a randomised, placebo-controlled, double-blind, 12-week clinical trial in children aged 4 to 11 years with mild to moderate persistent asthma. Patients were maintained on other inhaled corticosteroids with no washout period before randomisation. Treatments investigated were MF-DPI 100 mcg once daily in the evening (the US-approved paediatric dose), MF-DPI 100 mcg twice daily, and placebo. FEF_25%-75% was measured by spirometry and from the single curve giving the largest sum of forced vital capacity plus forced expiratory volume in 1 second (FEV₁).

A total of 296 children were included in the study from 38 medical centres. The average age of the patients was 8 to 9 years, and most of the children where male and white. Baseline mean values for predicted FEV₁ ranged from 77.3% to 79.7%. Significant improvement in FEF[_]25%-75%[] began within the first week of treatment in the once-daily and twice-daily groups compared with placebo (P <= .033). Improvements ranged from 16.0% to 22.7% for the once-daily group, 17.7% to 32.7% in the twice-daily group, and 6.1% to 11.4% for the placebo group and were sustained throughout the study. The changes from baseline at endpoint were 14.0% for once-daily and 24.0% for twice-daily patients, versus 0.5% for placebo patients.

Dr. Noonan concluded that MF-DPI significantly improved small airway function in children with asthma.

"Compliance may be an added benefit because patients are more likely to be compliant with a once-at-bedtime regimen than twice-daily regimens," said Dr. Noonan.

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

[Presentation title: Small Airway Function Is Improved in Pediatric Asthma Patients Treated With Mometasone Furoate. Abstract 2834.41]