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Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients

Volume: 42 - Issue: 2

Firstpage: 57 - Lastpage: 62

V.J. Lund - J.H. Black - L.Z. Szabø - C. Schrewelius - A. ?ɂĶkerlund

This study evaluated the efficacy and tolerability of budesonide in an aqueous nasal spray
(BANS) in patients with chronic rhinosinusitis. In this double-blind, placebo-controlled, multicentre,
parallel-group study, patients (n=167) with persistent rhinosinusitis symptoms
despite 2-weeks’ antibiotic treatment were randomised to receive BANS 128 µg b.i.d. or placebo
for 20 weeks. Morning combined symptom scores (CSS) in patients receiving BANS
decreased by a mean of –1.85 (95% CI –2.27, –1.43), versus –1.02 (–1.43, –0.61) in the placebo
group (p=0.005); corresponding values for evening CSS were –1.78 (–2.22, –1.35) and
–1.02 (–1.45, –0.60), respectively (p=0.012). BANS produced significant reductions in nasal
congestion and discharge scores, and improved patients’ sense of smell (morning only), versus
placebo. Peak nasal inspiratory flow (PNIF) increased significantly during BANS treatment.
In allergic patients, BANS significantly (p<0.001) reduced both morning –1.40 (–2.18, –0.62)
and evening –1.37 (–2.15, –0.58) CSS from baseline versus placebo, but changes in non-allergic
patients (morning: –0.04 [–0.95, 0.87]; evening: 0.14 [–0.81, 1.09]) were not significant.
PNIF was significantly (p<0.01) increased in both allergic and non-allergic patients from
baseline versus placebo. BANS is an effective and well-tolerated treatment for chronic rhinosinusitis.

V.J. Lund - J.H. Black - L.Z. Szabø - C. Schrewelius - A. ?ɂĶkerlund - Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients
Rhinology 42-2: 57-62, 2004