Once-daily budesonide aqueous nasal spray for allergic rhinitis: a review.
BACKGROUND
Allergic rhinitis (AR) is a highly prevalent inflammatory condition with substantial direct and indirect costs. Intranasal corticosteroids are recommended as first-line therapy for moderate to severe persistent AR. Intranasal budesonide is effective and well tolerated; budesonide aqueous nasal spray (BANS) offers several advantages of potential importance to patients, including once-daily dosing at a low volume of spray in a formulation that is free of chlorofluorocarbon propellants, alcohol, benzalkonium chloride, and scents.


OBJECTIVE
This article reviews the findings of randomized, blinded studies assessing the efficacy, safety profile, quality-of-life effects, patient preference, and cost-effectiveness of once-daily BANS in the treatment of AR.


METHODS
A MEDLINE search (1966-April 2003) was conducted to identify potentially relevant English-language articles. Pertinent abstracts from recent allergy society meetings were also identified. The search strategy employed the medical subject heading terms budesonide, intranasal corticosteroid, or nasal steroid and allergic rhinitis. Selected studies were randomized, controlled clinical trials of once-daily BANS in patients with AR.


RESULTS
Based on the results of randomized, double-blind, controlled trials, once-daily BANS is an effective treatment for both seasonal and perennial AR at doses as low as 64 microg (one 32-microg spray per nostril). BANS was well tolerated in these studies, with an adverse-event profile similar to that of placebo, and caused no clinically meaningful suppression of hypothalamic-pituitary-adrenal axis function at doses 4-fold higher than the recommended starting dose. Once-daily administration of BANS 64 microg was similar in efficacy to mometasone furoate nasal spray 200 microg once daily; comparable doses of BANS and fluticasone propionate nasal spray (FPNS) were similar in efficacy as well. Based on specific sensory attributes, patients preferred BANS to FPNS at the recommended once-daily starting doses. BANS was associated with more days of treatment per prescription at a lower cost per day compared with other intranasal corticosteroids.


CONCLUSIONS
Based on the studies reviewed, BANS administered once daily is an effective and well-tolerated treatment for seasonal and perennial AR in both children and adults. Due to its sensory attributes, efficacy, safety profile, and relatively low cost, BANS may help improve patient adherence.
Stanaland
Brett E
BE
Division of Allergy and Immunology, University of South Florida Health Sciences Center, Tampa, Florida, USA. allerguy@aol.com
D000281:Administration, Intranasal; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*
D000893:Anti-Inflammatory Agents; D019819:Budesonide