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Efficacy of azelastine nasal spray in patients with an unsatisfactory response to loratadine.
Ann Allergy Asthma Immunol. 2003 Aug; 91(2):205-11.AA

Abstract

OBJECTIVE

To evaluate the effectiveness and safety of azelastine nasal spray, desloratadine, and the combination of azelastine nasal spray plus loratadine compared with placebo in patients with seasonal allergic rhinitis who had an unsatisfactory response to loratadine.

METHODS

This was a 2-week, multicenter, placebo-controlled, randomized, double-blind study in patients with moderate-to-severe symptoms of seasonal allergic rhinitis. Following a 1-week, open-label lead-in period, during which the patients received loratadine 10 mg daily, those patients who met the symptom qualification criteria (<25% to 33% improvement taking loratadine) were randomized to treatment with azelastine nasal spray 2 sprays per nostril, twice daily, azelastine nasal spray 2 sprays per nostril, twice daily, plus loratadine 10 mg daily, desloratadine 5 mg daily plus placebo (saline) nasal spray, or placebo (saline) nasal spray/placebo capsules. The primary efficacy variable was the change from baseline to day 14 in the total nasal symptom score, consisting of runny nose, sneezing, itchy nose, and nasal congestion symptom scores recorded twice daily (AM and PM) in patient diary cards.

RESULTS

A total of 428 patients with an unsatisfactory response to loratadine completed the double-blind treatment period. After 2 weeks of treatment, azelastine nasal spray (P < 0.001), azelastine nasal spray plus loratadine (P < 0.001), and desloratadine (P = 0.039) significantly improved the total nasal symptom score compared with placebo.

CONCLUSIONS

Azelastine nasal spray is an effective treatment for patients with seasonal allergic rhinitis who do not respond to loratadine and is an alternative to switching to another oral antihistamine or to using multiple antihistamines.

Authors+Show Affiliations

Southern California Research Center, Mission Viejo, California 92691, USA. weberger@uci.eduNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12952117

Citation

Berger, William E., et al. "Efficacy of Azelastine Nasal Spray in Patients With an Unsatisfactory Response to Loratadine." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 91, no. 2, 2003, pp. 205-11.
Berger WE, White MV, Rhinitis Study Group. Efficacy of azelastine nasal spray in patients with an unsatisfactory response to loratadine. Ann Allergy Asthma Immunol. 2003;91(2):205-11.
Berger, W. E., & White, M. V. (2003). Efficacy of azelastine nasal spray in patients with an unsatisfactory response to loratadine. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 91(2), 205-11.
Berger WE, White MV, Rhinitis Study Group. Efficacy of Azelastine Nasal Spray in Patients With an Unsatisfactory Response to Loratadine. Ann Allergy Asthma Immunol. 2003;91(2):205-11. PubMed PMID: 12952117.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of azelastine nasal spray in patients with an unsatisfactory response to loratadine. AU - Berger,William E, AU - White,Martha V, AU - ,, PY - 2003/9/4/pubmed PY - 2003/10/1/medline PY - 2003/9/4/entrez SP - 205 EP - 11 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 91 IS - 2 N2 - OBJECTIVE: To evaluate the effectiveness and safety of azelastine nasal spray, desloratadine, and the combination of azelastine nasal spray plus loratadine compared with placebo in patients with seasonal allergic rhinitis who had an unsatisfactory response to loratadine. METHODS: This was a 2-week, multicenter, placebo-controlled, randomized, double-blind study in patients with moderate-to-severe symptoms of seasonal allergic rhinitis. Following a 1-week, open-label lead-in period, during which the patients received loratadine 10 mg daily, those patients who met the symptom qualification criteria (<25% to 33% improvement taking loratadine) were randomized to treatment with azelastine nasal spray 2 sprays per nostril, twice daily, azelastine nasal spray 2 sprays per nostril, twice daily, plus loratadine 10 mg daily, desloratadine 5 mg daily plus placebo (saline) nasal spray, or placebo (saline) nasal spray/placebo capsules. The primary efficacy variable was the change from baseline to day 14 in the total nasal symptom score, consisting of runny nose, sneezing, itchy nose, and nasal congestion symptom scores recorded twice daily (AM and PM) in patient diary cards. RESULTS: A total of 428 patients with an unsatisfactory response to loratadine completed the double-blind treatment period. After 2 weeks of treatment, azelastine nasal spray (P < 0.001), azelastine nasal spray plus loratadine (P < 0.001), and desloratadine (P = 0.039) significantly improved the total nasal symptom score compared with placebo. CONCLUSIONS: Azelastine nasal spray is an effective treatment for patients with seasonal allergic rhinitis who do not respond to loratadine and is an alternative to switching to another oral antihistamine or to using multiple antihistamines. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/12952117/Efficacy_of_azelastine_nasal_spray_in_patients_with_an_unsatisfactory_response_to_loratadine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)62179-5 DB - PRIME DP - Unbound Medicine ER -