An evaluation of the efficacy and safety of azelastine in patients with chronic asthma. Azelastine-Asthma Study Group.
BACKGROUND
Azelastine, an oral nonsteroidal, antiinflammatory drug with a good safety profile, has demonstrated relief of symptoms in patients with asthma.


OBJECTIVE
The study was designed to evaluate the efficacy and safety of azelastine, a novel antiallergy compound, in patients with asthma who required maintenance therapy.


METHODS
During this 16-week, double-blind, randomized, parallel-group study, patients received orally administered azelastine (4 mg twice daily), albuterol sulfate (4 mg twice daily), or placebo.


RESULTS
Overall, patients in the azelastine group used 2.5 times less backup medication (p = 0.024) for relief of their asthma symptoms than patients in the placebo group. Reductions in asthma symptoms in the azelastine group were also noted throughout the double-blind treatment period. Moreover, the azelastine group had statistically significant improvements in FEV1 after the first dose of medication. The only notable adverse experiences in the azelastine group were alterations in taste perception and a small mean increase in body weight.


CONCLUSIONS
Oral administration of azelastine to patients with asthma resulted in overall improvement in airway function while reducing the requirement for adjunctive antiasthma medications.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D002908:Chronic Disease; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D010793:Phthalazines / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010793:Phthalazines; D000420:Albuterol; C020976:azelastine