title: Safety and clinical relief over 1 year with triamcinolone acetonide hydrofluoroalkane-134a nasal aerosol in patients with perennial allergic rhinitis.
abstract: 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.
authors.affiliation: Department of Medicine, Allergy Division, National Jewish Medical and Research Center, 1400 Jackson Street, Denver, CO 80206-2762, USA. weberr@njc.org
authors.forename: Richard
authors.initials: R
authors.lastname: Weber
authors.forename: Jorge
authors.initials: J
authors.lastname: Garcia
authors.forename: Rab
authors.initials: R
authors.lastname: Faruqi
authors.forename: Donald
authors.initials: D
authors.lastname: Banerji
authors.forename: George
authors.initials: G
authors.lastname: Georges
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000335:Aerosol Propellants; D000368:Aged; D002648:Child; D004334:Drug Administration Schedule; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006845:Hydrocarbons, Fluorinated; D008297:Male; D008875:Middle Aged; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects; D005466:Fluorocarbons
chemical_list: D000335:Aerosol Propellants; D005938:Glucocorticoids; D006845:Hydrocarbons, Fluorinated; D014222:Triamcinolone Acetonide; C094049:apaflurane; D005466:Fluorocarbons