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Effectiveness of azelastine nasal spray compared with oral cetirizine in patients with seasonal allergic rhinitis.
Clin Ther 2005; 27(5):543-53CT

Abstract

BACKGROUND

Azelastine nasal spray and oral cetirizine are selective histamine H(1)-receptor antagonists that are approved in the United States for the treatment of seasonal allergic rhinitis (SAR).

OBJECTIVE

The objective of the present study was to compare the efficacy and tolerability of azelastine nasal spray administered at the recommended dosage of 2 sprays per nostril twice daily with those of cetirizine in the treatment of moderate to severe SAR.

METHODS

This multicenter, randomized, double-blind, parallel-group, 2-week comparative study was conducted during the 2004 fall allergy season in patients with moderate to severe SAR. After a 1-week placebo lead-in period, patients were randomized to receive azelastine nasal spray 2 sprays per nostril twice daily plus placebo tablets or cetirizine 10-mg tablets once daily plus a placebo saline nasal spray for the 2-week double-blind treatment period. The primary efficacy variables were (1) change from baseline to day 14 in the 12-hour reflective total nasal symptom score (TNSS), which combines scores for rhinorrhea, sneezing, itchy nose, and nasal congestion, and (2) onset of action, based on the instantaneous TNSS over 4 hours after the first dose of study drug. During the double-blind treatment period, patients recorded their symptom scores on diary cards twice daily (morning and evening). Patients aged > or =18 years also completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at baseline and on day 14.

RESULTS

Three hundred seven patients were randomized to treatment, and 299 completed 2 weeks of study treatment. The age of the population ranged from 12 to 74 years (mean, 35 years), 62.9% were female, and 69.6% were white. Over 2 weeks of treatment, both groups had significant improvements in the TNSS compared with baseline (P < 0.001). The overall change in TNSS was significantly greater with azelastine nasal spray compared with cetirizine (29.3% vs 23.0% improvement, respectively; P = 0.015). In terms of onset of action, azelastine nasal spray significantly improved the instantaneous TNSS compared with cetirizine at 60 and 240 minutes after the initial dose (both, P = 0.040). Scores on each domain of the RQLQ were significantly improved in both groups compared with baseline (P < 0.001); the overall RQLQ score was significantly improved with azelastine nasal spray compared with cetirizine (P = 0.049). Both treatments were well tolerated.

CONCLUSION

In this 2-week study in patients with moderate to severe SAR, azelastine nasal spray was well tolerated and produced significantly greater improvements in TNSS and total RQLQ score compared with cetirizine.

Authors+Show Affiliations

Allergy Research Foundation, Inc., Los Angeles, California 90025, USA. joncorren@hotmail.comNo 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
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

15978303

Citation

Corren, Jonathan, et al. "Effectiveness of Azelastine Nasal Spray Compared With Oral Cetirizine in Patients With Seasonal Allergic Rhinitis." Clinical Therapeutics, vol. 27, no. 5, 2005, pp. 543-53.
Corren J, Storms W, Bernstein J, et al. Effectiveness of azelastine nasal spray compared with oral cetirizine in patients with seasonal allergic rhinitis. Clin Ther. 2005;27(5):543-53.
Corren, J., Storms, W., Bernstein, J., Berger, W., Nayak, A., & Sacks, H. (2005). Effectiveness of azelastine nasal spray compared with oral cetirizine in patients with seasonal allergic rhinitis. Clinical Therapeutics, 27(5), pp. 543-53.
Corren J, et al. Effectiveness of Azelastine Nasal Spray Compared With Oral Cetirizine in Patients With Seasonal Allergic Rhinitis. Clin Ther. 2005;27(5):543-53. PubMed PMID: 15978303.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of azelastine nasal spray compared with oral cetirizine in patients with seasonal allergic rhinitis. AU - Corren,Jonathan, AU - Storms,William, AU - Bernstein,Jonathan, AU - Berger,William, AU - Nayak,Anjuli, AU - Sacks,Harry, AU - ,, PY - 2005/04/08/accepted PY - 2005/6/28/pubmed PY - 2005/10/12/medline PY - 2005/6/28/entrez SP - 543 EP - 53 JF - Clinical therapeutics JO - Clin Ther VL - 27 IS - 5 N2 - BACKGROUND: Azelastine nasal spray and oral cetirizine are selective histamine H(1)-receptor antagonists that are approved in the United States for the treatment of seasonal allergic rhinitis (SAR). OBJECTIVE: The objective of the present study was to compare the efficacy and tolerability of azelastine nasal spray administered at the recommended dosage of 2 sprays per nostril twice daily with those of cetirizine in the treatment of moderate to severe SAR. METHODS: This multicenter, randomized, double-blind, parallel-group, 2-week comparative study was conducted during the 2004 fall allergy season in patients with moderate to severe SAR. After a 1-week placebo lead-in period, patients were randomized to receive azelastine nasal spray 2 sprays per nostril twice daily plus placebo tablets or cetirizine 10-mg tablets once daily plus a placebo saline nasal spray for the 2-week double-blind treatment period. The primary efficacy variables were (1) change from baseline to day 14 in the 12-hour reflective total nasal symptom score (TNSS), which combines scores for rhinorrhea, sneezing, itchy nose, and nasal congestion, and (2) onset of action, based on the instantaneous TNSS over 4 hours after the first dose of study drug. During the double-blind treatment period, patients recorded their symptom scores on diary cards twice daily (morning and evening). Patients aged > or =18 years also completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at baseline and on day 14. RESULTS: Three hundred seven patients were randomized to treatment, and 299 completed 2 weeks of study treatment. The age of the population ranged from 12 to 74 years (mean, 35 years), 62.9% were female, and 69.6% were white. Over 2 weeks of treatment, both groups had significant improvements in the TNSS compared with baseline (P < 0.001). The overall change in TNSS was significantly greater with azelastine nasal spray compared with cetirizine (29.3% vs 23.0% improvement, respectively; P = 0.015). In terms of onset of action, azelastine nasal spray significantly improved the instantaneous TNSS compared with cetirizine at 60 and 240 minutes after the initial dose (both, P = 0.040). Scores on each domain of the RQLQ were significantly improved in both groups compared with baseline (P < 0.001); the overall RQLQ score was significantly improved with azelastine nasal spray compared with cetirizine (P = 0.049). Both treatments were well tolerated. CONCLUSION: In this 2-week study in patients with moderate to severe SAR, azelastine nasal spray was well tolerated and produced significantly greater improvements in TNSS and total RQLQ score compared with cetirizine. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/15978303/Effectiveness_of_azelastine_nasal_spray_compared_with_oral_cetirizine_in_patients_with_seasonal_allergic_rhinitis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(05)00075-5 DB - PRIME DP - Unbound Medicine ER -