title: A dose-response study of the bronchodilator action of azelastine in asthma.
abstract: Azelastine is an orally effective inhibitor of mediator activity in allergic reactions and has also been demonstrated to have bronchodilator activity. In this randomized, double-blind, placebo-controlled, multicenter study, 150 patients, aged 12 to 60 years, with moderate to severe asthma, received a single oral dose of 2, 4, 8, 12, or 16 mg of azelastine or placebo. Theophylline was stopped 24 hours and other bronchodilators at least 8 hours before the study day. Patients were evaluated for 8 hours after dose by spirometry and were monitored for adverse effects. All doses of azelastine produced bronchodilation with 4 mg greater than 2 mg greater than placebo; higher doses did not increase magnitude or duration of effect. We conclude that azelastine produces significant bronchodilation of long duration. The optimal dose appears to be 4 mg for adolescent and adult patients with asthma.
authors.forename: J P
authors.initials: JP
authors.lastname: Kemp
authors.forename: E O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: H A
authors.initials: HA
authors.lastname: Orgel
authors.forename: M J
authors.initials: MJ
authors.lastname: Welch
authors.forename: G A
authors.initials: GA
authors.lastname: Bucholtz
authors.forename: E
authors.initials: E
authors.lastname: Middleton
authors.forename: S L
authors.initials: SL
authors.lastname: Spector
authors.forename: J J
authors.initials: JJ
authors.lastname: Newton
authors.forename: J L
authors.initials: JL
authors.lastname: Perhach
mesh_terms: D000293:Adolescent; D000328:Adult; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D002648:Child; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D007700:Kinetics; D008176:Lung Volume Measurements; D008875:Middle Aged; D010793:Phthalazines / Q000627:therapeutic use*; D011724:Pyridazines / Q000627:therapeutic use*; D011897:Random Allocation; D013806:Theophylline / Q000097:blood
chemical_list: D001993:Bronchodilator Agents; D010793:Phthalazines; D011724:Pyridazines; D013806:Theophylline; C020976:azelastine