B. Pedersen et al., ONCE-DAILY FLUTICASONE PROPIONATE AQUEOUS NASAL SPRAY CONTROLS SYMPTOMS OF MOST PATIENTS WITH SEASONAL ALLERGIC RHINITIS, Allergy, 50(10), 1995, pp. 794-799
This multicentre, randomized, double-blind, parallel-group study was d
esigned to compare the efficacy and tolerability of fluticasone propio
nate aqueous nasal spray 200 mu g once daily (FPANS 200 mu g od) with
FPANS 200 mu g twice daily (bd) in patients whose seasonal rhinitis sy
mptoms were not completely controlled with FPANS 200 mu g od. A total
of 549 patients initially received FPANS 200 mu g od during the open-t
reatment phase of the study. After 2 weeks, 65% of patients had their
symptoms well controlled by FPANS 200 mu g od and continued with this
treatment for a further 2 weeks. The remainder received either FPANS 2
00 mu g od or FPANS 200 mu g bd for a further 2 weeks. Efficacy was ev
aluated by the analysis of symptom-free days. In the uncontrolled grou
p, there was a significant increase in the percentage of symptom-free
days in the FPANS 200 mu g bd group over the FPANS 200 mu g od group f
or nasal blockage on waking (P < 0.05) and nasal blockage during the d
ay (P < 0.05). Similar trends were observed for sneezing, rhinorrhoea,
nasal itching, and eye symptoms. There was a significant increase in
the percentage of days with a symptom score of less than 2 in the FPAN
S 200 mu g bd group for nasal blockage during the day (P < 0.05). Adve
rse events were similar in nature and frequency in each treatment grou
p. It is concluded that in the majority of patients symptoms of season
al rhinitis are well controlled by FPANS 200 mu g od. In the minority
of patients whose symptoms are not adequately controlled by a once dai
ly dose, FPANS 200 mu g bd provides additional relief, particularly fr
om nasal blockage.