Corticosteroid-sparing effect of azelastine in the management of bronchial asthma.
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.
Busse
W W
WW
Department of Medicine, University of Wisconsin, Madison 53792, USA.
Middleton
E
E
Storms
W
W
Dockhorn
R J
RJ
Chu
T J
TJ
Grossman
J
J
Weiler
J M
JM
Bronsky
E A
EA
Mansfield
L E
LE
Bell
T D
TD
Hemsworth
G R
GR
Perhach
J L
JL
D'Eletto
T A
TA
Dam
A
A
D000280:Administration, Inhalation; D000287:Administration, Topical; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage / Q000627:therapeutic use; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D002648:Child; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids; D006634:Histamine H1 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010793:Phthalazines / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D013997:Time Factors
D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D005938:Glucocorticoids; D006634:Histamine H1 Antagonists; D010793:Phthalazines; D010919:Placebos; D001507:Beclomethasone; C020976:azelastine