Multicenter, double-blind, multiple-dose, parallel-groups efficacy and safety trial of azelastine, chlorpheniramine, and placebo in the treatment of spring allergic rhinitis

John M. Weiler, Arlene Donnelly, Bruce H. Campbell, John T. Connell, Louis Diamond, Lyle H. Hamilton, Richard R Rosenthal, George R. Hemsworth, James L. Perhach

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)801-811
Number of pages11
JournalThe Journal of Allergy and Clinical Immunology
Volume82
Issue number5 PART 1
DOIs
StatePublished - 1988
Externally publishedYes

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azelastine
Chlorpheniramine
Placebos
Safety
Blood Cell Count
Therapeutics
Dysgeusia
Taste Perception
Anti-Allergic Agents
Seasonal Allergic Rhinitis
Vital Signs
Sleep Stages
Skin Tests
Allergic Rhinitis
Electrocardiography
Body Weight
Urine

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy

Cite this

Multicenter, double-blind, multiple-dose, parallel-groups efficacy and safety trial of azelastine, chlorpheniramine, and placebo in the treatment of spring allergic rhinitis. / Weiler, John M.; Donnelly, Arlene; Campbell, Bruce H.; Connell, John T.; Diamond, Louis; Hamilton, Lyle H.; Rosenthal, Richard R; Hemsworth, George R.; Perhach, James L.

In: The Journal of Allergy and Clinical Immunology, Vol. 82, No. 5 PART 1, 1988, p. 801-811.

Research output: Contribution to journalArticle

Weiler, John M. ; Donnelly, Arlene ; Campbell, Bruce H. ; Connell, John T. ; Diamond, Louis ; Hamilton, Lyle H. ; Rosenthal, Richard R ; Hemsworth, George R. ; Perhach, James L. / Multicenter, double-blind, multiple-dose, parallel-groups efficacy and safety trial of azelastine, chlorpheniramine, and placebo in the treatment of spring allergic rhinitis. In: The Journal of Allergy and Clinical Immunology. 1988 ; Vol. 82, No. 5 PART 1. pp. 801-811.
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abstract = "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.",
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