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Efficacy and safety of azelastine nasal spray at a dose of 1 spray per nostril twice daily.
Ann Allergy Asthma Immunol 2007; 99(3):267-72AA

Abstract

BACKGROUND

Azelastine hydrochloride nasal spray is available worldwide for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis. One spray per nostril twice daily is the most commonly recommended dose.

OBJECTIVE

To determine the efficacy and safety of azelastine nasal spray, 1 spray per nostril twice daily, in patients with SAR.

METHODS

In 2 studies conducted in the United States we assessed 554 patients with moderate-to-severe SAR who were still symptomatic after a 1-week placebo lead-in period. Patients were randomized to 2 weeks of double-blind treatment with azelastine nasal spray, 1 spray per nostril twice daily, or placebo nasal spray. The primary efficacy variable was change from baseline in total nasal symptom score, consisting of sneezing, itchy nose, runny nose, and nasal congestion.

RESULTS

Mean differences in total nasal symptom score between the azelastine and placebo groups were significant in both studies: 2.69 vs 1.31 (P = .01) in study 1 and 3.68 vs 2.50 (P = .02) in study 2. Bitter taste was reported by 8.3% of patients treated with 1 spray per nostril twice daily compared with the labeled incidence of 19.7% with 2 sprays per nostril twice daily. Somnolence was reported by 1 patient (0.4%) using the 1-spray regimen compared with the labeled incidence of 11.5% using the 2-spray regimen.

CONCLUSIONS

Azelastine nasal spray at a dose of 1 spray per nostril twice daily is effective and has improved tolerability compared with 2 sprays per nostril twice daily in patients with SAR.

Authors+Show Affiliations

AARA Research Center, Dallas, Texas 75231, USA. lumrymd@sbcglobal.netNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17910331

Citation

Lumry, William, et al. "Efficacy and Safety of Azelastine Nasal Spray at a Dose of 1 Spray Per Nostril Twice Daily." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 99, no. 3, 2007, pp. 267-72.
Lumry W, Prenner B, Corren J, et al. Efficacy and safety of azelastine nasal spray at a dose of 1 spray per nostril twice daily. Ann Allergy Asthma Immunol. 2007;99(3):267-72.
Lumry, W., Prenner, B., Corren, J., & Wheeler, W. (2007). Efficacy and safety of azelastine nasal spray at a dose of 1 spray per nostril twice daily. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 99(3), pp. 267-72.
Lumry W, et al. Efficacy and Safety of Azelastine Nasal Spray at a Dose of 1 Spray Per Nostril Twice Daily. Ann Allergy Asthma Immunol. 2007;99(3):267-72. PubMed PMID: 17910331.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of azelastine nasal spray at a dose of 1 spray per nostril twice daily. AU - Lumry,William, AU - Prenner,Bruce, AU - Corren,Jonathan, AU - Wheeler,William, PY - 2007/10/4/pubmed PY - 2007/11/9/medline PY - 2007/10/4/entrez SP - 267 EP - 72 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 99 IS - 3 N2 - BACKGROUND: Azelastine hydrochloride nasal spray is available worldwide for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis. One spray per nostril twice daily is the most commonly recommended dose. OBJECTIVE: To determine the efficacy and safety of azelastine nasal spray, 1 spray per nostril twice daily, in patients with SAR. METHODS: In 2 studies conducted in the United States we assessed 554 patients with moderate-to-severe SAR who were still symptomatic after a 1-week placebo lead-in period. Patients were randomized to 2 weeks of double-blind treatment with azelastine nasal spray, 1 spray per nostril twice daily, or placebo nasal spray. The primary efficacy variable was change from baseline in total nasal symptom score, consisting of sneezing, itchy nose, runny nose, and nasal congestion. RESULTS: Mean differences in total nasal symptom score between the azelastine and placebo groups were significant in both studies: 2.69 vs 1.31 (P = .01) in study 1 and 3.68 vs 2.50 (P = .02) in study 2. Bitter taste was reported by 8.3% of patients treated with 1 spray per nostril twice daily compared with the labeled incidence of 19.7% with 2 sprays per nostril twice daily. Somnolence was reported by 1 patient (0.4%) using the 1-spray regimen compared with the labeled incidence of 11.5% using the 2-spray regimen. CONCLUSIONS: Azelastine nasal spray at a dose of 1 spray per nostril twice daily is effective and has improved tolerability compared with 2 sprays per nostril twice daily in patients with SAR. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/17910331/Efficacy_and_safety_of_azelastine_nasal_spray_at_a_dose_of_1_spray_per_nostril_twice_daily_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)60663-1 DB - PRIME DP - Unbound Medicine ER -