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Efficacy and Tolerability of Budesonide Aqueous Nasal Spray Treatment in Patients With Nasal Polyps
Roger Jankowski, MD;
Camilla Schrewelius, DDS;
Pierre Bonfils, MD;
Yves Saban, MD;
Laurent Gilain, MD;
Jean-Michel Prades, MD;
Vladimir Strunski, MD
Arch Otolaryngol Head Neck Surg. 2001;127:447-452.
Objective To assess the efficacy and tolerability of once-daily treatment with
budesonide aqueous nasal spray in patients with nasal polyps.
Design Randomized, double-blind, placebo-controlled, parallel-group study.
Setting Sixteen hospital clinics.
Patients One hundred eighty-three patients with moderate-sized nasal polyps causing
clinically significant symptoms during a 1-week run-in period.
Interventions Patients were randomized to receive 1 of the following 4 budesonide
aqueous nasal spray treatments: 128 µg once daily in the morning and
placebo in the evening, 128 µg twice daily, 256 µg once daily
in the morning and placebo in the evening, or placebo for 8 weeks. Nasal polyp
size was scored and peak nasal inspiratory flow was measured at clinic visits
at the beginning and end of the run-in period and after 4 and 8 weeks' treatment.
Patients recorded daily peak nasal inspiratory flow, symptom scores (ie, blocked
nose, runny nose, and sneezing) and sense of smell on diary cards.
Main Outcome Measures Mean change in nasal polyp size at the end of treatment; mean changes
in combined and individual symptom scores.
Results All doses of budesonide aqueous nasal spray significantly (P<.01)
reduced polyp size; no significant differences were noted between the 4 treatment
groups. The mean improvement in clinic peak nasal inspiratory flow at 8 weeks
was 65.9 L/min with budesonide aqueous nasal spray, 128 µg twice daily;
71.6 L/min with budesonide aqueous nasal spray, 256 µg once daily; and
54.6 L/min with budesonide aqueous nasal spray, 128 µg once daily (all P<.001 vs placebo). Combined and individual symptom scores and sense
of smell improved significantly in all budesonide-treated groups; the effect
on symptoms became apparent within 1 to 2 days of the first dose. Budesonide
aqueous nasal spray was well tolerated.
Conclusions Doses of budesonide aqueous nasal spray, 128 µg once daily, were
found to be effective in the treatment of nasal polyps, and doses of budesonide
aqueous nasal spray, 256 µg once daily, did not show any significant
additional efficacy.
From the Department of Otorhinolaryngology, Hôpital Central,
Nancy (Dr Jankowski); Department of Otorhinolaryngology, Hôpital Boucicaut,
Paris (Dr Bonfils); Centre Hospitalier Universitaire, Clermont-Ferrand (Dr
Gilain); Department of Otorhinolaryngology, Hôpital de Bellevue, St-Etienne
(Dr Parades); Department of Otolaryngology, Centre Hospitalier du Nord Amiens,
Amiens (Dr Strunski), France; and Clinical Operations, AstraZeneca Research
and Development, Lund, Sweden (Dr Schrewelius). Dr Saban is in private practice
in Nice, France.
Corresponding author: Roger Jankowski, MD, Department of Otorhinolaryngology,
Head and Neck Surgery, Central Hospital, H. Poincaré University, F-54000
Nancy, France.
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ABSTRACT
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