A randomized, placebo-controlled, double-blind crossover study was performe
d to investigate the efficacy of ciclesonide nasal spray in allergic rhinit
is at the dose level of 200 mu g per nostril. Twenty-four subjects (13 male
s, 11 females; median age: 28 years) with a history of allergic rhinitis bu
t free of symptoms at screening entered the study. Ciclesonide and placebo
were given for 7 days each with a washout period of at least 14 days in bet
ween. In both treatment periods, controlled intranasal allergen provocation
with pollen extracts was performed on the 2 days before start of treatment
(days-2 and -1) and on all treatment days (days 1 to 7) about 2 hours afte
r administration of the study medication. At 5 and 30 minutes after each al
lergen provocation, rhinal airflow was measured by anterior rhinomanometry,
and the subjective symptoms of obstruction, itching, and rhinorrhea were a
ssessed by means of a standardized visual analog scale. Rhinal airflow impr
oved significantly from day 5, while the subjective symptom of obstruction
improved from day 2. Itching and rhinorrhea also improved significantly The
local and systemic tolerability of ciclesonide nasal spray was excellent T
he results of this study clearly indicate that the new topical steroid cicl
esonide is effective in the treatment of allergic rhinitis without producin
g local or systemic side effects. Journal of Clinical Pharmacology, 1999;39
:1062-1069 (C)1999 the American College of Clinical Pharmacology.