Double-blind, placebo-controlled study of the efficacy and tolerability of nimesulide administered orally in acute bronchial asthma.

In this double-blind, placebo-controlled study, children with acute exacerbation of bronchial asthma between the ages of 1 and 12 years not responding to conventional therapy with bronchodilators and injectable steroids were enrolled. A total of 60 children (two groups of 30 each) was studied. The overall response to therapy was assessed based on the guidelines and recommendations of the National Heart, Lung and Blood Institute. The efficacy parameters included respiratory and heart rates, degree of dyspnea, accessory muscle usage, color, wheeze, and degree of oxygen saturation. Children with moderate to severe exacerbation received either nimesulide suspension 1.5 mg/kg per dose or identical placebo orally as per random protocol. To assess the clinical progress, all the efficacy parameters were reassessed after 30 minutes and 1, 2, and 6 hours. A significant difference was observed in the overall assessment of response at 1, 2, and 6 hours in the two treatment groups. A greater number of children showed a good overall response in the nimesulide group compared with the placebo group at 1, 2, and 6 hours (P <.01). No side effects were reported in any of the patients in either group. None of the patients was withdrawn prematurely from either group. It is evident from the current study that nimesulide showed good efficacy and tolerability. Therefore, nimesulide could be administered to asthmatic patients whenever there is a need for such therapy.