Am. J. Respir. Crit. Care Med., Vol 153, No. 1, Jan 1996, 122-127.
Corticosteroid-sparing effect of azelastine in the management of bronchial asthma
WW Busse, E Middleton, W Storms, RJ Dockhorn, TJ Chu, J Grossman, JM Weiler, EA Bronsky, LE Mansfield, TD Bell, GR Hemsworth, JL Perhach, TA D'Eletto and A Dam
Department of Medicine, University of Wisconsin, Madison 53792, USA.
The objective of this double-blind trial was to evaluate the
corticosteroid-sparing effect of azelastine in patients with chronic
bronchial asthma. A total of 193 subjects received either 6 mg of
azelastine twice per day or placebo (in a 2:1 ratio) in combination with
beclomethasone dipropionate (6 to 16 inhalations per day). The number of
daily inhalations of the corticosteroid was reduced until maximum reduction
or elimination was achieved. Patients then entered a 12-wk maintenance
period, during which patients were maintained on their lowest possible dose
of inhaled corticosteroid. Compared with placebo, the azelastine group had
a statistically significantly greater overall median reduction in inhaled
corticosteroids (4.9 puffs/day for azelastine versus 3.1 puffs/day for
placebo; p < or = 0.010) during the maintenance period. The azelastine
group also had a statistically significantly higher percentage of patients
with reductions of > or = 50% and > or = 75% from the baseline level
(53 and 31%, respectively, for azelastine versus 34 and 14%, respectively,
for placebo; p < or = 0.028). The results demonstrated that azelastine,
6 mg twice per day, can reduce the need for inhaled corticosteroids in
patients with chronic bronchial asthma and not lead to a deterioration in
pulmonary function.
