Comparison of once daily fluticasone propionate aqueous nasal spray with once daily budesonide reservoir powder device in patients with perennial rhinitis

Authors


D. H. Richards, GlaxoWellcome plc, Respiratory Therapy Development, Stockley Park West, Uxbridge, Middlesex UB11 1BT, UK. E-mail: dhr7742@gsk.com

Abstract

Background Previous studies comparing the corticosteroids fluticasone propionate (FP) and budesonide (BUD) in both perennial and seasonal rhinitis have shown no consistent difference between treatments. However, the therapeutic outcomes may have been influenced by study design.

Objective To compare the effect of FP aqueous nasal spray (ANS; 200 µg/day) with BUD reservoir powder device (RPD; 200 µg/day) on rhinitis symptoms, productivity loss and device preference in patients with perennial rhinitis.

Methods After a 2-week run-in period, 440 patients were randomized to receive either FPANS, BUD RPD or matched placebo (ANS or RPD) for 8 weeks, followed by an open-label 4-week follow-up treatment with FPANS. Patients completed diary card visual analogue scores for nasal symptoms, and questionnaires on satisfaction with the treatment and preferred choice of device.

Results During weeks 1–4, the visual analogue total nasal symptom scores (VATNS) in the FPANS group were significantly lower than scores in the BUD RPD group (mean difference =−17.8; 95% CI = −34.4, −1.3; P = 0.036). FPANS also significantly reduced the VATNS compared with the ANS placebo at all time-points assessed (P ≤ 0.005). BUD RPD did not significantly differ from the RPD placebo at weeks 5–8 (P = 0.167), or the ANS placebo at any time-point (P ≤ 0.151). Over the 8-week treatment period FPANS was significantly more effective than BUD RPD at reducing sneezing (mean difference =−4.4; 95% CI = −8.6, −0.3; P = 0.036) and nasal itching (mean difference =−5.3; 95% CI = −9.9, −0.8; P = 0.022), and was significantly superior to the ANS placebo for all symptoms assessed at weeks 1–4 and 1–8 (P < 0.016). At the same time-points BUD RPD was no better at alleviating nasal itching than the RPD placebo (P ≤ 0.306), and compared with the ANS placebo, significantly reduced only one symptom; nasal blockage (P ≤ 0.016). After 8 weeks of treatment, patients preferred the ANS device to the RPD (P < 0.001), and at 12 weeks a significantly greater number of patients were satisfied with FPANS treatment compared with BUD RPD (P = 0.0019) or the respective placebos (P = 0.0001).

Conclusion FPANS and BUD RPD are effective therapies with a good safety profile for the treatment of perennial rhinitis but, in this direct placebo-controlled comparison, FPANS was more efficacious than BUD RPD, and the patients preferred the ANS device to the RPD.

Ancillary