Multicenter, double-blind, multiple-dose, parallel-groups efficacy and safety trial of azelastine, chlorpheniramine, and placebo in the treatment of spring allergic rhinitis. J Allergy Clin Immunol 1988 Nov;82(5 Pt 1):801-11
Date
11/01/1988Pubmed ID
3057041DOI
10.1016/0091-6749(88)90082-6Scopus ID
2-s2.0-0024261715 (requires institutional sign-in at Scopus site) 36 CitationsAbstract
Azelastine, a novel antiallergic medication, was compared with chlorpheniramine maleate and placebo for efficacy and safety in the treatment of spring allergic rhinitis in a multicenter, double-blind, multiple-dose, parallel-groups study. One hundred fifty-five subjects participated. Subjects ranged in age from 18 to 60 years of age and had at least a 2-year history of spring allergic rhinitis, confirmed by positive skin test to spring aeroallergens. Medications were given four times daily; the azelastine groups received 0.5, 1.0, or 2.0 mg in the morning and evening with placebo in the early and late afternoon; the chlorpheniramine group received 4.0 mg four times daily. Daily subject symptom cards were completed during a screening period to assess pretreatment symptoms and during a 4-week treatment period while subjects received study medications. Individual symptoms, total symptoms, and major symptoms were compared to determine efficacy of medication. Elicited, volunteered, and observed adverse experiences were recorded for each subject and compared among groups. Vital signs, body weights, serum chemistry values, complete blood cell counts, urine studies, and electrocardiograms were obtained for each subject and compared among groups. Symptoms relief in the group receiving the highest concentration of azelastine (2.0 mg twice daily) was statistically greater than in the placebo group during all weeks of the study. Lower doses of azelastine were statistically more effective than placebo only during portions of the first 3 weeks of the study. In contrast, although the chlorpheniramine group did have fewer symptoms than the placebo group during the study, the difference never reached statistical significance during any week of the study. There were no serious side effects in any of the treatment groups. Drowsiness and altered taste perception were increased significantly over placebo only in the high-dose azelastine group. Azelastine appears to be a safe, efficacious medication for seasonal allergic rhinitis.
Author List
Weiler JM, Donnelly A, Campbell BH, Connell JT, Diamond L, Hamilton LH, Rosenthal RR, Hemsworth GR, Perhach JL JrAuthor
Bruce H. Campbell MD Emeritus Professor in the Otolaryngology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Chlorpheniramine
Circadian Rhythm
Clinical Trials as Topic
Dizziness
Double-Blind Method
Drug Administration Schedule
Female
Humans
Male
Middle Aged
Multicenter Studies as Topic
Phthalazines
Placebos
Pyridazines
Rhinitis, Allergic, Seasonal
Seasons
Sleep Stages
Taste
