Double blind study of half dose of budesonide for the treatment of perennial rhinitis in Thai adults

Abstract

OBJECTIVES: 1, To compare the short-term effectiveness of budesonide aqueous nasal spray between once daily doses of 200 micrograms and 400 micrograms for the treatment of Thai adults with perennial rhinitis during a three-week duration. 2. To compare the short-term adverse reactions of budesonide aqueous nasal spray between once daily doses of 200 micrograms and 400 micrograms. 3 To compare the cost-effectiveness of budesonide between the two dosages STUDY DESIGN: Double-blinded, randomized controlled trial METHODOLOGY: Two-hundred and thirty three Thai adult patients with perennial rhinitis who fulfilled the eligibility criteria and gave written informed consent were included into this study. After 7-day run-in period, eligible patients were stratified into two groups according to the severity of average total nasal symptom score: less than 2 and at least 2. Then each subgroup were allocated into blocks of four patients and randomly allocated by using random number to generate into the 200 or 400 micrograms/day budesonide treatment group. The effectiveness of the treatment was evaluated by patient’s subjective assessment using symptom rating scale and the adverse reactions were assessed by patient’s self assessment and physician's assessment. Cost-effectiveness was also evaluated. RESULT : After one, two and three-week completion of using budesonide aqueous nasal spray, the dosage of 400 micrograms daily was significant statistically and clinically more effective in controlling nasal symptoms than 200 micrograms daily. When analyzed by using Generalized Estimated Equations statistic for repeated binary outcome, the effectiveness of budesonide 400 micrograms daily was 1.2 times that of budesonide 200 micrograms daily with the 95% confidence interval between 1.01-1.40 times. There was no significant difference in the occurrence of adverse reactions between the two doses.