Evaluation of olopatadine hydrochloride nasal spray, 0.6%, used in combination with an intranasal corticosteroid in seasonal allergic rhinitis.

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: Craig F LaForce, Warner Carr, Stephen A Tilles, Bradley E Chipps, William Storms, Eli O Meltzer, Michael Edwards
• Journal: Allergy and asthma proceedings (Allergy Asthma Proc) 2010 Mar-Apr Vol. 31 Issue 2 Pg. 132-40 ISSN: 1539-6304 [Electronic] United States
• PMID: 20302683 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Androstadienes
• Dibenzoxepins
• Histamine Antagonists
• Phthalazines
• Olopatadine Hydrochloride
• Fluticasone
• azelastine

Topics

• Administration, Intranasal
• Adult
• Androstadienes (administration & dosage, adverse effects)
• Dibenzoxepins (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Fluticasone
• Histamine Antagonists (administration & dosage, adverse effects)
• Humans
• Middle Aged
• Olopatadine Hydrochloride
• Phthalazines (administration & dosage, adverse effects)
• Rhinitis, Allergic, Seasonal (drug therapy, physiopathology)
• Treatment Outcome
• Ulcer (etiology)
• Xerostomia (etiology)