Safety and clinical relief over 1 year with triamcinolone acetonide hydrofluoroalkane-134a nasal aerosol in patients with perennial allergic rhinitis

The intranasal corticosteroid triamcinolone acetonide (TAA) is an effective treatment for allergic rhinitis (AR). A new hydrofluoroalkane-134a (HFA)–propelled formulation (TAA-HFA) has been approved recently. This study assessed the safety and efficacy of TAA-HFA in patients with perennial AR over 1 year. A total of 396 patients aged 12–69 years with perennial AR (PAR) enrolled in this 1-year, open-label study. Patients received TAA-HFA, 220 g, once daily for 2 weeks before adjusting their dose to 440 or 110 g once daily as needed to control symptoms. Doses were standardized to 440 g across all patients at ∼4 months. Physical examinations, vital signs, and laboratory measurements were conducted at baseline, 6 months, and study end. Patient and physician global symptom evaluations were performed at visits 3–10. Patients recorded any adverse events (AEs) on daily diary cards. Of the 396 patients enrolled, 349 (88.1%) reported AEs. The most frequently reported AEs were pharyngitis, rhinitis, local reactions, headache, epistaxis, and sinusitis. Most AEs were mild to moderate in intensity; 34 patients discontinued because of AEs. There were no clinically relevant changes in physical examinations, vital signs, or laboratory measurements. A total of four serious AEs were reported; all were recorded as not related to study drug. Mean patient and physician scores of symptom relief showed significant relief from week 2 (visit 3) through the final visit. Long-term administration of TAA-HFA, 440 g, exhibited a good safety and tolerability profile, while providing moderate-to-complete symptom relief as rated by patients and physicians.