The efficacy of fluticasone propionate aqueous nasal spray for allergic rhinitis and its relationship to topical effects

• Published in: Clinical therapeutics 1996-11, Vol.18 (6), p.1106-1117
• Main Authors: Howland, William C., Hampel, Frank C., Martin, Bruce G., Ratner, Paul H., van Bavel, Julius H., Field, Elizabeth A.
• Format: Article
• Language: English
• Subjects: Absorption; Administration, Intranasal; Administration, Oral; Adolescent; Adult; Androstadienes - administration & dosage; Androstadienes - adverse effects; Androstadienes - pharmacokinetics; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - adverse effects; Anti-Inflammatory Agents - pharmacokinetics; Biological and medical sciences; Bones, joints and connective tissue. Antiinflammatory agents; Child; Chlorpheniramine - administration & dosage; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Fluticasone; Follow-Up Studies; Histamine H1 Antagonists - administration & dosage; Humans; Hydrocortisone - blood; Male; Medical sciences; Nebulizers and Vaporizers; Pharmacology. Drug treatments; Radioimmunoassay; Rhinitis, Allergic, Seasonal - blood; Rhinitis, Allergic, Seasonal - diagnosis; Rhinitis, Allergic, Seasonal - drug therapy; Safety; Treatment Outcome
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/S0149-2918(96)80065-8

Fluticasone propionate aqueous nasal spray is an intranasal corticosteroid for the treatment of patients with allergic rhinitis. This double-masked, double-dummy, parallel-group study was conducted to confirm that the efficacy of fluticasone propionate nasal spray is attributable to topical rather than systemic effects. A total of 304 patients with documented seasonal allergic rhinitis were randomly assigned to receive fluticasone propionate nasal spray 200 μg once daily (n = 77), oral fluticasone propionate 5 mg once daily (n = 73), oral fluticasone propionate 10 mg once daily (n = 77), or placebo (n = 77) for 14 days. Plasma fluticasone propionate concentrations were determined at baseline and after 14 days of treatment (day 15). Nasal symptoms were recorded daily by patients and assessed weekly by clinicians. On day 15, more patients in the oral fluticasone propionate 5-mg or 10-mg groups, compared with patients in the fluticasone propionate nasal spray group or the placebo group, had detectable plasma fluticasone propionate concentrations, and mean concentrations were higher in the oral fluticasone propionate groups. Both clinician- and patient-rated total and individual nasal symptom scores for obstruction, rhinorrhea, sneezing, and itching were significantly lower in the fluticasone propionate nasal spray group compared with either of the oral fluticasone propionate groups or the placebo group. With few exceptions, oral fluticasone propionate (5 mg or 10 mg) was not significantly different from placebo on any measures of efficacy. These findings indicate that the efficacy of fluticasone propionate nasal spray (200 μg once daily) in the treatment of allergic rhinitis results from direct topical effects rather than from indirect effects after systemic absorption.