Comparison of powder and aerosolized budesonide in perennial rhinitis: validation of rhinitis quality of life questionnaire.

The aims of the study were to compare the efficacy and side effects of intranasal budesonide as a dry powder and as a freon propelled pressurized aerosol in the treatment of perennial rhinitis and to validate a perennial rhinitis quality of life questionnaire. The design was a single-blind, randomized, parallel group comparison of two active treatments over a 6-week period. Sixty adults with symptomatic perennial rhinitis, stratified for atopy, received 400 micrograms intranasal budesonide administered daily either as one inhalation/nostril/day of pure drug powder or two puffs/nostril/day of drug delivered by a freon propelled aerosol. Subjects kept daily symptom diaries and, at each clinic visit, rhinitis quality of life and adverse experiences were recorded. Fifty-eight subjects completed the study. During the 6 weeks, there were significant improvements in symptoms and quality of life in both treatment groups. The improvements tended to be slightly greater in the aerosol group but the differences did not reach significance. Most frequently reported adverse experiences were headache and nosebleed, which were equally distributed in the two groups. We conclude that budesonide taken 400 micrograms daily for 6 weeks was associated with improvements in perennial rhinitis with little evidence of any difference in efficacy or side effects between the powder and aerosol. The questionnaire is a valid instrument for assessing quality of life in perennial rhinitis clinical trials.

RCT Entities:   Population Interventions Outcomes