标题：Randomized, Open Label, Active Controlled comparative study to assess Safety, Efficacy of Mometasone & Formoterol versus Fluticasone & Formoterol dry powder inhaler in treatment of Mild to Moderate Persistent Asthma
摘要："Background: Asthma is a problem worldwide, with an estimated 300 million affected individuals. Mometasone being newer drug has low systemic bioavailability, high glucocorticoid receptor affinity and modifies inflammatory mediators involved in the pathogenesis of asthma compared to other inhaled corticosteroids. There are very few studies conducted to assess and compare the safety and efficacy of Mometasone & Formoterol versus Fluticasone & Formoterol. Hence the present study was undertaken to assess the safety and efficacy of these dry powder inhaler in patients with mild to moderate persistent asthma on symptom control and rescue medication usage. Method: The present study was conducted in Preventive Medicine Unit and TB & Chest diseases OPD, KIMS Hospital & Research centre, Bangalore during March 2011 to February 2012. 60 patients were recruited in each group based on inclusion and exclusion criteria. Study medications were randomized and were given for 12weeks & comparison was done to know safety, efficacy and usage of rescue medication before and after treatment. Statistical test used were descriptive statistics, repeated ANOVA, Z- test, t- test. Result: Out of 60 patients recruited in each group 7 were lost to follow up in Fluticasone group and 4 in Mometasone group. Out of 53 patients in Fluticasone group, 11 developed adverse reactions. Whereas in Mometasone group out of 56 patients- 7 developed adverse reactions. The overall improvement in Spirometry parameters was better in Mometasone group compared to Fluticasone which was not statistically significant suggesting both were equally efficacious. There was reduction in dosage of rescue medication used from baseline to the end of 12 weeks in Mometasone group compared to Fluticasone group. Conclusion: Both combinations were safe and equally efficacious in treating mild to moderate persistent asthma patients."
关键词：Mild to moderate persistent Asthma; dry powder inhaler; safety; efficacy
