PMID- 16913268 OWN - NLM STAT- MEDLINE DCOM- 20061020 LR - 20190608 IS - 1088-5412 (Print) IS - 1088-5412 (Linking) VI - 27 IP - 3 DP - 2006 May-Jun TI - Safety and clinical relief over 1 year with triamcinolone acetonide hydrofluoroalkane-134a nasal aerosol in patients with perennial allergic rhinitis. PG - 243-7 AB - 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. FAU - Weber, Richard AU - Weber R AD - Department of Medicine, Allergy Division, National Jewish Medical and Research Center, 1400 Jackson Street, Denver, CO 80206-2762, USA. weberr@njc.org FAU - Garcia, Jorge AU - Garcia J FAU - Faruqi, Rab AU - Faruqi R FAU - Banerji, Donald AU - Banerji D FAU - Georges, George AU - Georges G CN - 405 Investigator Group LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - United States TA - Allergy Asthma Proc JT - Allergy and asthma proceedings JID - 9603640 RN - 0 (Aerosol Propellants) RN - 0 (Glucocorticoids) RN - 0 (Hydrocarbons, Fluorinated) RN - F446C597KA (Triamcinolone Acetonide) RN - R40P36GDK6 (apaflurane) SB - IM MH - Administration, Intranasal MH - Adolescent MH - Adult MH - *Aerosol Propellants MH - Aged MH - Child MH - Drug Administration Schedule MH - Female MH - Glucocorticoids/*administration & dosage/adverse effects MH - Humans MH - *Hydrocarbons, Fluorinated MH - Male MH - Middle Aged MH - Rhinitis, Allergic, Perennial/*drug therapy MH - Treatment Outcome MH - Triamcinolone Acetonide/*administration & dosage/adverse effects EDAT- 2006/08/18 09:00 MHDA- 2006/10/21 09:00 CRDT- 2006/08/18 09:00 PHST- 2006/08/18 09:00 [pubmed] PHST- 2006/10/21 09:00 [medline] PHST- 2006/08/18 09:00 [entrez] AID - 10.2500/aap.2006.27.2848 [doi] PST - ppublish SO - Allergy Asthma Proc. 2006 May-Jun;27(3):243-7. doi: 10.2500/aap.2006.27.2848.