M. Tos et al., EFFICACY OF AN AQUEOUS AND A POWDER FORMULATION OF NASAL BUDESONIDE COMPARED IN PATIENTS WITH NASAL POLYPS, American journal of rhinology, 12(3), 1998, pp. 183-189
Nasal polyps are commonly treated surgically, Intranasal administratio
n of topical corticosteroids has gained increased acceptance as a trea
tment alternative. The aim of our study was to compare the efficacy of
treatment of two formulations of budesonide with placebo on nasal pol
yps. At four Danish clinics 138 patients suffering from moderate or se
vere nasal polyps were randomized to a twice daily treatment with Rhin
ocort(R) Aqua 128 mu g, Rhinocort Turbuhaler(R) 140 mu g or placebo (A
stra Draco, Sweden) for 6 weeks. Polyp size (primary efficacy variable
), nasal symptoms, sense of smell, and patients' overall evaluation of
treatment of efficacy were assessed by scores. Polyp size was reduced
significantly in both budesonide treated groups compared with placebo
, but there was no statistical difference between the two actively tre
ated groups. Patients' nasal symptom scores was significantly more red
uced in the Aqua compared to the Turbuhaler treated group, and both re
duced symptom scores were significantly better compared to placebo. Se
nse of smell was significantly improved in the actively treated groups
compared to placebo. The proportion of patients rating substantial or
total control over symptoms after 6 weeks treatment was 60.9% and 48.
2% in the Aqua and Turbuhaler-treated groups, respectively which was s
ignificantly better compared with 29.8% in the placebo-treated group.
Rhinocort Aqua and Rhinocort Turbuhaler were equally well tolerated.