A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CONTROLLED ANTIGEN DELIVERY STUDY OF THE ONSET OF ACTION OF AEROSOLIZED TRIAMCINOLONE ACETONIDE NASAL SPRAY IN SUBJECTS WITH RAGWEED-INDUCED ALLERGIC RHINITIS

Background: Clinically apparent relief of nasal symptoms of allergic r hinitis is generally recognized to occur. within 3 days to 1 week when intranasal corticosteroids are used. Objective: A study was designed to evaluate the onset of action of triamcinolone acetonide (TA) in pat ients with ragweed-induced allergic rhinitis with an environmental exp osure unit (EEU). Methods: Eighty-five adults with ragweed-induced all ergic rhinitis were primed with ragweed allergen in the EEU. Symptoms were recorded during a baseline exposure in the EEU, and subjects were randomized with a 5:1 ratio to receive either TA 400 mu g (n = 71) or its propellant (n = 14). Subjects received study medication for 7 day s under supervision in the morning and returned to the EEU in the even ing for ragweed allergen challenge and symptom assessment. Clinically apparent onset of action was defined as a 25% decrease in symptom scor es from baseline. Results: A mean reduction in nasal congestion from b aseline of greater than 25% (onset of action) was observed in the TA g roup, but not in the placebo group, by 10 hours. This was also observe d for itching of the nose or palate and a combined measure of symptoms . In addition, the proportion of subjects with less nasal congestion a fter 1 day of treatment was greater in the TA group (41%) than in the placebo group (7%) (p < 0.05). Conclusion: The unexpected early relief of symptoms observed in the TA group and, to a lesser extent in the p lacebo group, has important clinical implications in the treatment of allergic rhinitis.