title: New formulation of aqueous flunisolide nasal spray in the treatment of allergic rhinitis: comparative assessment of safety, tolerability, and efficacy.
abstract: This 6-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial compared the safety, efficacy, and tolerability of a new formulation of flunisolide nasal spray with the original formulation in the treatment of allergic rhinitis due to mountain cedar pollenosis. It was conducted at three clinical centers in close geographic proximity. A total of 216 patients, ranging in age from 14 to 77 years (mean, 44 years), took at least one dose of study drug and therefore were evaluable for the safety analysis. A total of 185 patients (85%) completed the study, and 136 patients were evaluable for the efficacy analysis. Both formulations of flunisolide were comparable in terms of relief of rhinitis symptoms, and the new flunisolide formulation was better tolerated than the original formulation. Both active formulations were superior to their respective vehicles (P < 0.001) using multiple measures of allergic rhinitis symptoms relief. Use of escape medication (chlorpheniramine maleate) was significantly (P < or = 0.034) greater in the placebo group when compared with their respective active treatment groups. No therapeutic effect was observed with symptoms of allergic conjunctivitis. Significantly fewer patients who were treated with the new formulation flunisolide reported nasal burning and stinging when compared with the original formulation (P = 0.006). In conclusion, the new formulation showed similar efficacy and improved tolerability in the treatment of allergic rhinitis compared with the original formulation. This new formulation not only offers clinicians a useful therapeutic addition for the treatment of allergic rhinitis, but may also improve patient compliance.
authors.affiliation: Sylvana Research, San Antonio, Texas, USA.
authors.forename: P
authors.initials: P
authors.lastname: Ratner
authors.forename: J
authors.initials: J
authors.lastname: van Bavel
authors.forename: G
authors.initials: G
authors.lastname: Gross
authors.forename: L
authors.initials: L
authors.lastname: Bynum
authors.forename: A
authors.initials: A
authors.lastname: Munshi
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004339:Drug Compounding; D005446:Fluocinolone Acetonide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008875:Middle Aged; D009297:Nasal Mucosa / Q000187:drug effects / Q000503:physiopathology; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D000893:Anti-Inflammatory Agents; D005446:Fluocinolone Acetonide; C007734:flunisolide