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Clinical Note |

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(4):447-452. doi:10.1001/archotol.127.4.447.
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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.

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Figure 1.

Scheme showing the disposition of the patients. All doses of budesonide were administered by an aqueous nasal spray (Rhinocort Aqua; Astra Draco AB, Lund, Sweden).

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Figure 2.

Mean nasal polyp size scores. All patients received budesonide aqueous nasal spray treatment (Rhinocort Aqua; Astra Draco AB, Lund, Sweden) or placebo. For an explanation of the nasal polyp size see the "Assessments" subsection of the "Patients and Methods" section. No polyps were sized as 0 or 1.

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Figure 3.

Mean peak nasal inspiratory flow (PNIF). All patients received budesonide aqueous nasal spray treatment (Rhinocort Aqua; Astra Draco AB, Lund, Sweden) or placebo.

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Figure 4.

Combined nasal symptoms. All patients received budesonide aqueous nasal spray treatment (Rhinocort Aqua; Astra Draco AB, Lund, Sweden) or placebo.

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Figure 5.

Mean reductions in combined symptom score compared with placebo during the first 4 days of treatment. All patients received budesonide aqueous nasal spray treatment (Rhinocort Aqua; Astra Draco AB, Lund, Sweden). Single asterisk indicates P<.05; double asterisk, P<.001.

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Figure 6.

Changes in individual nasal symptom scores and sense of smell for blocked nose (A), runny nose (B), sneezing (C), and sense of smell (D). All patients received budesonide aqueous nasal spray treatment (Rhinocort Aqua; Astra Draco AB, Lund, Sweden) or placebo.

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