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Safety and efficacy of azelastine nasal spray (Astelin NS) for seasonal allergic rhinitis: a 4-week comparative multicenter trial.
Ann Allergy Asthma Immunol 1996; 76(2):181-8AA

Abstract

BACKGROUND

Azelastine is a chemically novel investigational antiallergy drug with the ability to antagonize the effects of chemical mediators of the early- phase and late phase allergic responses suggesting its usefulness in the treatment of upper and lower airway diseases.

OBJECTIVE

The objective of this 4-week, double- bind, multicenter trial was to evaluate the efficacy of azelastine nasal spray in subjects with seasonal allergic rhinitis.

METHODS

Two hundred sixty-four subjects 12 years of age and older were randomized to receive either azelastine, 2 sprays/nostril qd; azelastine, 2 sprays/nostril bid; oral chlorpheniramine maleate, 12 mg bid; or placebo. The primary efficacy parameters were the changes in major and total symptom severity scores.

RESULTS

Overall, across all 4 weeks of treatment, the mean percent improvements in the total and major symptom complex severity scores in both azelastine treatment groups were greater than those for the placebo group. For the azelastine 2 sprays bid group, the overall results were significant at P = .05 for the major symptom complex score and at .05 < P = .10 for the total symptom complex score versus placebo. For both azelastine treatment groups, improvements in all of the individual rhinitis symptoms were superior to those for the placebo group and, in general were clinically and statistically significant. Azelastine nasal spray was well tolerated; adverse experiences were generally application site reactions, mild to moderate, and not limiting to continued treatment.

CONCLUSIONS

Azelastine nasal spray demonstrated broad clinical antirhinitis activity that for the 2 sprays/nostril bid dosage regimen was consistently clinically and statistically significant.

Authors+Show Affiliations

Carolina Allergy and Asthma Consultants, Raleigh, North Carolina, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

8595539

Citation

LaForce, C, et al. "Safety and Efficacy of Azelastine Nasal Spray (Astelin NS) for Seasonal Allergic Rhinitis: a 4-week Comparative Multicenter Trial." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 76, no. 2, 1996, pp. 181-8.
LaForce C, Dockhorn RJ, Prenner BM, et al. Safety and efficacy of azelastine nasal spray (Astelin NS) for seasonal allergic rhinitis: a 4-week comparative multicenter trial. Ann Allergy Asthma Immunol. 1996;76(2):181-8.
LaForce, C., Dockhorn, R. J., Prenner, B. M., Chu, T. J., Kraemer, M. J., Widlitz, M. D., ... Freitag, J. J. (1996). Safety and efficacy of azelastine nasal spray (Astelin NS) for seasonal allergic rhinitis: a 4-week comparative multicenter trial. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 76(2), pp. 181-8.
LaForce C, et al. Safety and Efficacy of Azelastine Nasal Spray (Astelin NS) for Seasonal Allergic Rhinitis: a 4-week Comparative Multicenter Trial. Ann Allergy Asthma Immunol. 1996;76(2):181-8. PubMed PMID: 8595539.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of azelastine nasal spray (Astelin NS) for seasonal allergic rhinitis: a 4-week comparative multicenter trial. AU - LaForce,C, AU - Dockhorn,R J, AU - Prenner,B M, AU - Chu,T J, AU - Kraemer,M J, AU - Widlitz,M D, AU - D'Eletto,T A, AU - Freitag,J J, PY - 1996/2/1/pubmed PY - 1996/2/1/medline PY - 1996/2/1/entrez SP - 181 EP - 8 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 76 IS - 2 N2 - BACKGROUND: Azelastine is a chemically novel investigational antiallergy drug with the ability to antagonize the effects of chemical mediators of the early- phase and late phase allergic responses suggesting its usefulness in the treatment of upper and lower airway diseases. OBJECTIVE: The objective of this 4-week, double- bind, multicenter trial was to evaluate the efficacy of azelastine nasal spray in subjects with seasonal allergic rhinitis. METHODS: Two hundred sixty-four subjects 12 years of age and older were randomized to receive either azelastine, 2 sprays/nostril qd; azelastine, 2 sprays/nostril bid; oral chlorpheniramine maleate, 12 mg bid; or placebo. The primary efficacy parameters were the changes in major and total symptom severity scores. RESULTS: Overall, across all 4 weeks of treatment, the mean percent improvements in the total and major symptom complex severity scores in both azelastine treatment groups were greater than those for the placebo group. For the azelastine 2 sprays bid group, the overall results were significant at P = .05 for the major symptom complex score and at .05 < P = .10 for the total symptom complex score versus placebo. For both azelastine treatment groups, improvements in all of the individual rhinitis symptoms were superior to those for the placebo group and, in general were clinically and statistically significant. Azelastine nasal spray was well tolerated; adverse experiences were generally application site reactions, mild to moderate, and not limiting to continued treatment. CONCLUSIONS: Azelastine nasal spray demonstrated broad clinical antirhinitis activity that for the 2 sprays/nostril bid dosage regimen was consistently clinically and statistically significant. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/8595539/Safety_and_efficacy_of_azelastine_nasal_spray__Astelin_NS__for_seasonal_allergic_rhinitis:_a_4_week_comparative_multicenter_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)63420-5 DB - PRIME DP - Unbound Medicine ER -