A multicentre study to assess long-term use of fluticasone propionate aqueous nasal spray in comparison with beclomethasone dipropionate aqueous nasal spray in the treatment of perennial rhinitis.

Two hundred and fifty-one patients, aged 16 years and over, with perennial rhinitis were recruited to this multicentre, randomized, double-blind, parallel group study. One hundred and fifty-nine patients received fluticasone propionate (200 micrograms) aqueous nasal spray (FPANS) twice daily, and 83 patients received beclomethasone dipropionate (200 micrograms) aqueous nasal spray (BDPANS) twice daily; treatment randomization being 2:1, respectively, in order to increase the number of patients in the FPANS group as FPANS was the drug under study. After 1 year of treatment, nasal blockage (p = 0.002), nasal discharge (p = 0.002) and eye watering/irritation (p = 0.048) were significantly improved in patients treated with FPANS twice daily, compared to patients treated with BDPANS twice daily. The symptom grades for nasal itching (p = 0.052) were improved in the FPANS group, but just failed to attain statistical significance at the 5% level. The symptom grades for sneezing tended to be better for the FPANS group, but the difference was not statistically significant. Assessment of changes in the findings during nasal examination (rhinoscopy) and in haematological, biochemical and urinary parameters, and measurements of plasma cortisol levels during the one year of treatment with the study drugs, showed that there were no clinically significant differences between the two treatment groups and that the study drugs were equally well tolerated. This study indicates that long-term use of FPANS provides better relief than BDPANS for most of the symptoms of perennial rhinitis.

RCT Entities:   Population Interventions Outcomes