TRIAMCINOLONE ACETONIDE AQUEOUS NASAL SPRAY FOR THE TREATMENT OF PATIENTS WITH PERENNIAL ALLERGIC RHINITIS - A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

In this multicenter, randomized, double-blind, placebo-controlled study, 178 patients with symptoms of perennial allergic rhinitis (PAR) were treated with either triamcinolone acetonide (TAA) Aqueous nasal spray (220 mu g once daily) or placebo for 4 weeks. Symptoms of PAR (nasal stuffiness, nasal discharge, sneezing, nasal index, and nasal itching) were evaluated throughout the treatment period through the use of patient diaries. In addition, both patients and physicians completed independent global evaluations of treatment efficacy at the conclusion of the study. TAA Aqueous provided clinically and statistically (P less than or equal to 0.05) greater improvements in nasal stuffiness, sneezing, nasal index, and nasal itching over the 4-week study period than did placebo. Significant improvements in sneezing (P = 0.022) were observed as early as the first day (within 12 to 16 hours based on treatment in the morning and assessment of symptoms at bedtime), and in the nasal index (P = 0.009) by the third day after treatment with TAA Aqueous. Patients' and physicians' global evaluations of overall efficacy were concordant: 65% of patients rated their nasal symptoms greatly or somewhat improved with TAA Aqueous compared with 48% in the placebo group; physicians rated 66% of patients as having greatly or somewhat improved symptoms with the study drug compared with 48% of patients who received placebo. Adverse events were mild and the incidences were comparable for both groups; no significant changes in vital signs or clinical laboratory parameters were observed. This study demonstrated that TAA Aqueous administered once daily was well tolerated and provided relief of PAR symptoms in adults and adolescents.