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Evaluation of olopatadine hydrochloride nasal spray, 0.6%, used in combination with an intranasal corticosteroid in seasonal allergic rhinitis.
Allergy Asthma Proc. 2010 Mar-Apr; 31(2):132-40.AA

Abstract

The combination of intranasal antihistamines and intranasal corticosteroids results in superior relief of seasonal allergic rhinitis (SAR) symptoms compared with monotherapy. This study was designed to evaluate the safety and efficacy of olopatadine hydrochloride nasal spray, 0.6% (OLO), administered in combination with fluticasone nasal spray, 50 micrograms (FNS), relative to azelastine nasal spray, 0.1% (AZE), administered in combination with FNS in the treatment of SAR. This was a multicenter, double-blind, randomized, parallel-group comparison of OLO + FNS versus AZE + FNS administered for 14 days to patients > or =12 years of age with histories of SAR. Efficacy assessments recorded by patients in a daily diary included nasal symptom scores. Safety was evaluated based on adverse events (AEs). Pretreatment values for reflective total nasal symptoms scores (rTNSS) were similar for both treatment groups. The mean (SD) 2-week average rTNSS was 4.28 (2.63) for OLO + FNS and 4.15 (2.63) for AZE + FNS; these scores were not statistically different between treatment groups. No significant differences (p > 0.05) between OLO + FNS and AZE + FNS were observed for the average 2-week percent changes from baseline in rTNSS or in the individual nasal symptoms (nasal congestion, rhinorrhea, itchy nose, and sneezing). Compared with baseline, both groups had statistically significant improvement in rTNSS (p < 0.05). No serious AEs were reported in either group during the study period. Overall, 19 AEs were reported in the OLO + FNS group and 29 AEs were reported in the AZE + FNS group. OLO, when administered adjunctively with FNS, is effective, safe, and well-tolerated in patients with SAR.

Authors+Show Affiliations

North Carolina Clinical Research, Raleigh, North Carolina 27607, USA. claforce@nccr.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

20302683

Citation

LaForce, Craig F., et al. "Evaluation of Olopatadine Hydrochloride Nasal Spray, 0.6%, Used in Combination With an Intranasal Corticosteroid in Seasonal Allergic Rhinitis." Allergy and Asthma Proceedings, vol. 31, no. 2, 2010, pp. 132-40.
LaForce CF, Carr W, Tilles SA, et al. Evaluation of olopatadine hydrochloride nasal spray, 0.6%, used in combination with an intranasal corticosteroid in seasonal allergic rhinitis. Allergy Asthma Proc. 2010;31(2):132-40.
LaForce, C. F., Carr, W., Tilles, S. A., Chipps, B. E., Storms, W., Meltzer, E. O., & Edwards, M. (2010). Evaluation of olopatadine hydrochloride nasal spray, 0.6%, used in combination with an intranasal corticosteroid in seasonal allergic rhinitis. Allergy and Asthma Proceedings, 31(2), 132-40. https://doi.org/10.2500/aap.2010.31.3326
LaForce CF, et al. Evaluation of Olopatadine Hydrochloride Nasal Spray, 0.6%, Used in Combination With an Intranasal Corticosteroid in Seasonal Allergic Rhinitis. Allergy Asthma Proc. 2010;31(2):132-40. PubMed PMID: 20302683.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of olopatadine hydrochloride nasal spray, 0.6%, used in combination with an intranasal corticosteroid in seasonal allergic rhinitis. AU - LaForce,Craig F, AU - Carr,Warner, AU - Tilles,Stephen A, AU - Chipps,Bradley E, AU - Storms,William, AU - Meltzer,Eli O, AU - Edwards,Michael, Y1 - 2010/03/18/ PY - 2010/3/23/entrez PY - 2010/3/23/pubmed PY - 2010/9/15/medline SP - 132 EP - 40 JF - Allergy and asthma proceedings JO - Allergy Asthma Proc VL - 31 IS - 2 N2 - The combination of intranasal antihistamines and intranasal corticosteroids results in superior relief of seasonal allergic rhinitis (SAR) symptoms compared with monotherapy. This study was designed to evaluate the safety and efficacy of olopatadine hydrochloride nasal spray, 0.6% (OLO), administered in combination with fluticasone nasal spray, 50 micrograms (FNS), relative to azelastine nasal spray, 0.1% (AZE), administered in combination with FNS in the treatment of SAR. This was a multicenter, double-blind, randomized, parallel-group comparison of OLO + FNS versus AZE + FNS administered for 14 days to patients > or =12 years of age with histories of SAR. Efficacy assessments recorded by patients in a daily diary included nasal symptom scores. Safety was evaluated based on adverse events (AEs). Pretreatment values for reflective total nasal symptoms scores (rTNSS) were similar for both treatment groups. The mean (SD) 2-week average rTNSS was 4.28 (2.63) for OLO + FNS and 4.15 (2.63) for AZE + FNS; these scores were not statistically different between treatment groups. No significant differences (p > 0.05) between OLO + FNS and AZE + FNS were observed for the average 2-week percent changes from baseline in rTNSS or in the individual nasal symptoms (nasal congestion, rhinorrhea, itchy nose, and sneezing). Compared with baseline, both groups had statistically significant improvement in rTNSS (p < 0.05). No serious AEs were reported in either group during the study period. Overall, 19 AEs were reported in the OLO + FNS group and 29 AEs were reported in the AZE + FNS group. OLO, when administered adjunctively with FNS, is effective, safe, and well-tolerated in patients with SAR. SN - 1539-6304 UR - https://www.unboundmedicine.com/medline/citation/20302683/Evaluation_of_olopatadine_hydrochloride_nasal_spray_0_6_used_in_combination_with_an_intranasal_corticosteroid_in_seasonal_allergic_rhinitis_ L2 - https://www.ingentaconnect.com/openurl?genre=article&amp;issn=1088-5412&amp;volume=31&amp;issue=2&amp;spage=132&amp;aulast=LaForce DB - PRIME DP - Unbound Medicine ER -