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

摘要

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 microg, once daily for 2 weeks before adjusting their dose to 440 or 110 microg once daily as needed to control symptoms. Doses were standardized to 440 microg across all patients at approximately 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 microg, exhibited a good safety and tolerability profile, while providing moderate-to-complete symptom relief as rated by patients and physicians.