PMID- 20302683 OWN - NLM STAT- MEDLINE DCOM- 20100914 LR - 20161020 IS - 1539-6304 (Electronic) IS - 1088-5412 (Linking) VI - 31 IP - 2 DP - 2010 Mar-Apr TI - Evaluation of olopatadine hydrochloride nasal spray, 0.6%, used in combination with an intranasal corticosteroid in seasonal allergic rhinitis. PG - 132-40 LID - 10.2500/aap.2010.31.3326 [doi] AB - 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. FAU - LaForce, Craig F AU - LaForce CF AD - North Carolina Clinical Research, Raleigh, North Carolina 27607, USA. claforce@nccr.com FAU - Carr, Warner AU - Carr W FAU - Tilles, Stephen A AU - Tilles SA FAU - Chipps, Bradley E AU - Chipps BE FAU - Storms, William AU - Storms W FAU - Meltzer, Eli O AU - Meltzer EO FAU - Edwards, Michael AU - Edwards M LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20100318 PL - United States TA - Allergy Asthma Proc JT - Allergy and asthma proceedings JID - 9603640 RN - 0 (Androstadienes) RN - 0 (Dibenzoxepins) RN - 0 (Histamine Antagonists) RN - 0 (Phthalazines) RN - 2XG66W44KF (Olopatadine Hydrochloride) RN - CUT2W21N7U (Fluticasone) RN - ZQI909440X (azelastine) SB - IM MH - Administration, Intranasal MH - Adult MH - Androstadienes/*administration & dosage/adverse effects MH - Dibenzoxepins/*administration & dosage/adverse effects MH - Double-Blind Method MH - Drug Therapy, Combination MH - Female MH - Fluticasone MH - Histamine Antagonists/*administration & dosage/adverse effects MH - Humans MH - Middle Aged MH - Olopatadine Hydrochloride MH - Phthalazines/*administration & dosage/adverse effects MH - Rhinitis, Allergic, Seasonal/*drug therapy/physiopathology MH - Treatment Outcome MH - Ulcer/etiology MH - Xerostomia/etiology EDAT- 2010/03/23 06:00 MHDA- 2010/09/15 06:00 CRDT- 2010/03/23 06:00 PHST- 2010/03/23 06:00 [entrez] PHST- 2010/03/23 06:00 [pubmed] PHST- 2010/09/15 06:00 [medline] AID - 3326 [pii] AID - 10.2500/aap.2010.31.3326 [doi] PST - ppublish SO - Allergy Asthma Proc. 2010 Mar-Apr;31(2):132-40. doi: 10.2500/aap.2010.31.3326. Epub 2010 Mar 18.