Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of azelastine 0.15% nasal spray administered once daily in subjects with seasonal allergic rhinitis.
Allergy Asthma Proc 2009 Sep-Oct; 30(5):512-8AA

Abstract

Azelastine nasal spray is commercially available as a 0.1% w/v solution and is recommended for twice-daily dosing. Increasing the azelastine concentration to 0.15% may be effective with once-daily dosing without increasing the incidence of adverse events. This study evaluated the efficacy and safety of azelastine 0.15% nasal spray at a dosage of 2 sprays/nostril once daily. This randomized, double-blind, placebo-controlled study was conducted in subjects with moderate-to-severe seasonal allergic rhinitis (SAR) during the 2007/2008 Texas Mountain Cedar season. In total, 536 subjects were randomized to 2 sprays/nostril once daily (A.M.) of azelastine 0.15% or placebo. The primary efficacy variable was change from baseline in a 12-hour reflective Total Nasal Symptom Score (TNSS), consisting of nasal congestion, runny nose, itchy nose, and sneezing. The key secondary variable was change from baseline in 24-hour instantaneous TNSS, which determines the duration of action and effective dosing interval. After 2 weeks, the mean improvement in 12-hour reflective TNSS and percentage improvement in 12-hour reflective TNSS were significant (p < 0.001) with azelastine 0.15% (19%) compared with placebo (10%). The improvement in 24-hour instantaneous TNSS also was significant (p < 0.001) for azelastine 0.15% compared with placebo, supporting efficacy with once-daily dosing. All individual TNSS symptoms were significantly (p < 0.01) improved with azelastine 0.15% compared with placebo. With the exception of bitter taste (4.5%) and nasal discomfort (4.5%), adverse events with azelastine 0.15% were reported with an incidence similar to placebo. Azelastine 0.15% nasal spray was effective and well tolerated in subjects with SAR with once-daily dosing.

Authors+Show Affiliations

Allergy and Asthma Associates, Austin, Texas, USA.No affiliation info availableNo 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

19747429

Citation

van Bavel, Julius, et al. "Efficacy and Safety of Azelastine 0.15% Nasal Spray Administered once Daily in Subjects With Seasonal Allergic Rhinitis." Allergy and Asthma Proceedings, vol. 30, no. 5, 2009, pp. 512-8.
van Bavel J, Howland WC, Amar NJ, et al. Efficacy and safety of azelastine 0.15% nasal spray administered once daily in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2009;30(5):512-8.
van Bavel, J., Howland, W. C., Amar, N. J., Wheeler, W., & Sacks, H. (2009). Efficacy and safety of azelastine 0.15% nasal spray administered once daily in subjects with seasonal allergic rhinitis. Allergy and Asthma Proceedings, 30(5), pp. 512-8. doi:10.2500/aap.2009.30.3284.
van Bavel J, et al. Efficacy and Safety of Azelastine 0.15% Nasal Spray Administered once Daily in Subjects With Seasonal Allergic Rhinitis. Allergy Asthma Proc. 2009;30(5):512-8. PubMed PMID: 19747429.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of azelastine 0.15% nasal spray administered once daily in subjects with seasonal allergic rhinitis. AU - van Bavel,Julius, AU - Howland,William C, AU - Amar,N J, AU - Wheeler,William, AU - Sacks,Harry, Y1 - 2009/09/10/ PY - 2009/9/15/entrez PY - 2009/9/15/pubmed PY - 2009/12/29/medline SP - 512 EP - 8 JF - Allergy and asthma proceedings JO - Allergy Asthma Proc VL - 30 IS - 5 N2 - Azelastine nasal spray is commercially available as a 0.1% w/v solution and is recommended for twice-daily dosing. Increasing the azelastine concentration to 0.15% may be effective with once-daily dosing without increasing the incidence of adverse events. This study evaluated the efficacy and safety of azelastine 0.15% nasal spray at a dosage of 2 sprays/nostril once daily. This randomized, double-blind, placebo-controlled study was conducted in subjects with moderate-to-severe seasonal allergic rhinitis (SAR) during the 2007/2008 Texas Mountain Cedar season. In total, 536 subjects were randomized to 2 sprays/nostril once daily (A.M.) of azelastine 0.15% or placebo. The primary efficacy variable was change from baseline in a 12-hour reflective Total Nasal Symptom Score (TNSS), consisting of nasal congestion, runny nose, itchy nose, and sneezing. The key secondary variable was change from baseline in 24-hour instantaneous TNSS, which determines the duration of action and effective dosing interval. After 2 weeks, the mean improvement in 12-hour reflective TNSS and percentage improvement in 12-hour reflective TNSS were significant (p < 0.001) with azelastine 0.15% (19%) compared with placebo (10%). The improvement in 24-hour instantaneous TNSS also was significant (p < 0.001) for azelastine 0.15% compared with placebo, supporting efficacy with once-daily dosing. All individual TNSS symptoms were significantly (p < 0.01) improved with azelastine 0.15% compared with placebo. With the exception of bitter taste (4.5%) and nasal discomfort (4.5%), adverse events with azelastine 0.15% were reported with an incidence similar to placebo. Azelastine 0.15% nasal spray was effective and well tolerated in subjects with SAR with once-daily dosing. SN - 1539-6304 UR - https://www.unboundmedicine.com/medline/citation/19747429/Efficacy_and_safety_of_azelastine_0_15_nasal_spray_administered_once_daily_in_subjects_with_seasonal_allergic_rhinitis_ L2 - https://www.ingentaconnect.com/openurl?genre=article&amp;issn=1088-5412&amp;volume=30&amp;issue=5&amp;spage=512&amp;aulast=van Bavel DB - PRIME DP - Unbound Medicine ER -