Original ArticlesDouble-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Nimesulide Administered Orally in Acute Bronchial AsthmaSethi, Gulsan R. *; Sharma, Sangeeta2; Batra, Vandana1; Sharma, Deepika R.3 Author Information 1Department of Pediatrics, LN Hospital, New Delhi; 2Department of Neuropsycho-pharmacology, Institute of Human Behavior & Allied Sciences, Delhi; and 3Medical Services, Panacea Biotec Ltd., New Delhi, India. *Address for correspondence: Department of Pediatrics, Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi 110 002, India; e-mail: [email protected] American Journal of Therapeutics: July 2002 - Volume 9 - Issue 4 - p 281-287 Buy Abstract 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 None of the patients was withdrawn prematurely from either group.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. © 2002 Lippincott Williams & Wilkins, Inc.