K. V. Laila, A. Mohamed Musthafa, C. Ravindran
BACKGROUND Asthma is one of the most common chronic diseases worldwide, imposing a substantial social burden. Inhaled glucocorticosteroids (ICS) are currently the most effective anti-inflammatory medications for treatment of asthma and they have revolutionised asthma therapy. Ciclesonide is a new once daily ICS with similar efficacy to other ICS in asthma, and it possesses potential advantages in terms of reduced local and systemic adverse effects. AIM To study the comparative efficacy and side effect profile of inhaled ciclesonide once daily with that of fluticasone twice daily in patients with asthma. METHOD OF STUDY An open labelled randomised controlled trial conducted during the period from Aug 2007 to Aug 2009 in patients with moderate persistent asthma. The patients were randomised into two groups to receive either Ciclesonide 160 mcg once daily or Fluticasone 250 mcg twice daily. Followup assessment done at 4th week, 8th week, and 12th week during which pre and postbronchodilator spirometry was done. The number of doses of rescue medications used, any exacerbations after the previous visit, any adverse effects experienced were all recorded during each visit. Post-trial analysis was done using ANCOVA (Analysis of Covariance). A p value of <0.05 was considered significant. RESULTS During the study period, both groups showed significant improvement in pulmonary function. The overall improvement in FEV1 and PEFR from baseline to the end of 12 weeks was better with ciclesonide when compared to fluticasone and was statistically significant with a p value of <0.05. There was a significant reduction in the number of doses of rescue medications used in the ciclesonide group with p value <0.01. With respect to the incidence of local adverse effects, ciclesonide was safer than fluticasone. CONCLUSIONS Compared to fluticasone, ciclesonide showed significantly better improvement in pulmonary function of patients with asthma without any local adverse effects
