IngentaConnect Comprehensive report of the efficacy, safety, quality of life, an...

Authors: Fairchild, Carol J.¹; Meltzer, Eli O.²; Roland, Peter S.³; Wells, David¹; Drake, Margaret¹; Wall, G. Michael¹

Source: Allergy and Asthma Proceedings, Volume 28, Number 6, November-December 2007 , pp. 716-723(8)

Publisher: OceanSide Publications, Inc

Abstract:

Seasonal allergic rhinitis (SAR) treatment should reduce symptoms and help patients resume normal function. This study was performed to determine the effect of olopatadine (Olo) nasal spray on symptoms, quality of life (QoL), work, and activities of SAR patients. A pooled analysis was conducted of two Institutional Review Board-approved, randomized, double-blind clinical trials that compared 2-week treatment with Olo 0.6% and Olo 0.4% to placebo. Symptoms were assessed with the Total Nasal Symptom Score (TNSS) from daily diaries. Health outcomes were measured by the Work Productivity and Activity Impairment Questionnaire-Allergy Specific (WPAI-AS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). The studies included 1240 SAR patients with a mean age of 37 years; 64% were women. TNSS and RQLQ improvements were significantly different from placebo: TNSS, Olo 0.6% (p < 0.0001) and Olo 0.4% (p < 0.0037); RQLQ, Olo 0.6% (p < 0.001) and Olo 0.4% (p < 0.05). WPAI-AS improvements also were significant for overall work impact and activity impairment in the Olo 0.6% (p < 0.001) and Olo 0.4% (p < 0.05). Correlations between Olo 0.6% TNSS scores and work impact were r = 0.45 (p < 0.0001); activities, r = 0.55 (p < 0.0001); and RQLQ score, r = 0.61 (p < 0.0001), indicating that symptom reduction with Olo therapy was associated with improvements in function and QoL. Adverse events were nonserious and infrequent in all treatment groups. The most frequent adverse events were unpleasant taste and headache. This analysis indicates that Olo is a safe and effective intranasal treatment and is associated with significant improvement in QoL and ability to perform work and conduct usual activities of SAR patients.

Keywords: Activity impairment; clinical trial; nasal spray; olopatadine; quality of life; RQLQ; seasonal allergic rhinitis; TNSS; work impairment; WPAI

Document Type: Research article

DOI: 10.2500/aap.2007.28.3062

Affiliations: 1: Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, Texas 2: University of California at San Diego, Allergy and Asthma Medical Group and Research Center, San Diego, California, and 3: Department of Otolaryngology Head and Neck Surgery, Neurological Surgery, Pediatric Otology, University of Texas Southwestern Medical Center, Dallas, Texas

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Comprehensive report of the efficacy, safety, quality of life, and work impact of Olopatadine 0.6% and Olopatadine 0.4% treatment in patients with seasonal allergic rhinitis