Efficacy and tolerability of budesonide aqueous nasal spray treatment in patients with nasal polyps.

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 microg once daily in the morning and placebo in the evening, 128 microg twice daily, 256 microg 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 microg twice daily; 71.6 L/min with budesonide aqueous nasal spray, 256 microg once daily; and 54.6 L/min with budesonide aqueous nasal spray, 128 microg 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 microg once daily, were found to be effective in the treatment of nasal polyps, and doses of budesonide aqueous nasal spray, 256 microg once daily, did not show any significant additional efficacy.

A randomized controlled trial showing efficacy of once daily intranasal budesonide in nasal polyposis.

A randomized, double-blind, placebo-controlled trial was performed to assess the efficacy of once daily budesonide in patients with nasal polyps. After a 2-week run-in period, 157 patients with symptomatic bilateral nasal polyposis were randomized to receive budesonide, 140 micrograms once or twice daily or 280 micrograms once daily (delivered doses) via Turbuhaler, or placebo for 8 weeks. Polyp size was assessed endoscopically and, in two centres, by magnetic resonance imaging (MRI). Nasal symptoms (blocked nose, runny nose, sneezing) were recorded daily, and patients provided an overall assessment of efficacy at the end of the study. Budesonide, 280 micrograms/day (280 micrograms o.d. and 140 micrograms twice daily), significantly reduced polyp size, compared with placebo, whereas budesonide, 140 micrograms once daily, had no significant effect. Nasal polyp mass score, measured by MRI, was also significantly reduced in patients receiving 280 micrograms/day. All three doses of budesonide significantly reduced symptom scores, and there were no significant differences between the groups. Overall, approximately 70% of patients receiving budesonide, 280 micrograms/day, reported substantial or total control of symptoms, compared with 45% of placebo-treated patients. It is concluded that budesonide, 280 micrograms once daily, reduces polyp size and relieves symptoms in patients with nasal polyposis.

N-acetylcysteine added to saliva does not affect IgA concentration or the agglutination of Streptococcus mutans in vitro.

N-acetylcysteine (NAC) or placebo were mixed with parotid or whole saliva to a final concentration of 0.004-10 mg/ml saliva. Placebo and NAC-containing parotid saliva had the same bacterial agglutinating capacity for 4 strains of Streptococcus mutans. Immunoglobulin A (IgA) concentration in whole saliva, using ELISA and single radial immunodiffusion assays, did not reveal any differences between NAC and placebo-treated samples. NAC did not affect the immunoelectrophoretic pattern of IgA.

Ostial function in allergic rhinitis.

In order to evaluate the maxillary ostial function a double-blind, group comparative study with intranasal budesonide and placebo was carried out in 20 adult patients suffering from seasonal rhinitis. The trial started with an entry visit 3 weeks before pollen peak with clinical assessments (physical examination and ostial diameter measurements) followed by a 3-week treatment period. Treatment was either intranasal budesonide 200 micrograms b.i.d. or matching placebo b.i.d. The trail ended at pollen peak with clinical assessment. The results showed normal ostial diameters in the patients suffering from seasonal rhinitis. There were no statistical significant differences in ostial diameter change between the treatment groups except between budesonide and placebo in sitting position at measurement time 0 min. It seems that pollen does not reach the ostial region.

Topical treatment with aqueous solutions of rofleponide palmitate and budesonide in a pollen-season model of allergic rhinitis.

BACKGROUND: Rofleponide palmitate is an esterified glucocorticosteroid pro-drug with a promising pre-clinical profile designed to deliver topical airway treatment for allergic rhinitis and asthma in a novel manner. Thus, the rofleponide palmitate pro-drug is designed to provide topical exposure of the mucosa to the inactive lipophilic drug, which would be locally metabolized to the more hydrophilic and readily cleared drug rofleponide. OBJECTIVE: To examine whether rofleponide palmitate affects nasal symptoms and peak inspiratory flow (PIF) in a pollen-season model of allergic rhinitis and to compare any such effects with those of another glucocorticosteroid (i.e., budesonide). METHODS: During the pollen-free season, 40 patients with strictly seasonal allergic rhinitis received topical nasal spray treatment with an aqueous solution of rofleponide palmitate 400 microg and an aqueous solution of budesonide 128 microg once daily for 10 days in a double-blind, placebo-controlled, and crossover study. After 3 days of drug treatment, individualized allergen challenges were given once daily for 7 days while the treatment continued. The washout periods between each of the challenge series were 2 weeks. Nasal symptoms and PIF were recorded in the morning and evening, as well as 10 and 20 min after each allergen challenge. The mean recordings obtained during the last 3 days of the allergen-challenge series, when symptoms were established and when the treatment had lasted for 8-10 days, were used in the analysis. RESULTS: Both active treatments reduced nasal symptoms and improved nasal PIF compared with placebo (P<0.01-0.001). There was no overall difference in efficacy between rofleponide palmitate 400 microg and budesonide 128 microg. CONCLUSIONS: Topical treatment with aqueous solutions of rofleponide palmitate attenuates nasal symptoms and improves nasal PIF in allergic rhinitis. The overall efficacy of 400 microg of rofleponide palmitate is similar to that of 128 microg of budesonide in the pollen-season model used in this study.

Clinical efficacy of budesonide in the treatment of eczematous external otitis.

Sixty patients with mild to moderate forms of eczematous otitis externa were treated with budesonide and placebo in a double-blind controlled study using parallel groups. Each treatment period was preceded by otomicroscopic examination and thorough cleaning of the ear canal. The symptoms and signs were assessed with a score system ranging from 0 (no symptoms/signs) to 3 (severe symptoms/signs). Budesonide treatment was associated with a reduction in severity of all symptoms recorded and a marked improvement in erythema, swelling and discharge. Mechanical cleaning of the ear canal and placebo was not a sufficient treatment for this group of patients.

A comparison of aqueous suspensions of budesonide nasal spray (128 micrograms and 256 micrograms once daily) and fluticasone propionate nasal spray (200 micrograms once daily) in the treatment of adult patients with seasonal allergic rhinitis.

The efficacy of aqueous suspensions of budesonide nasal spray and fluticasone propionate nasal spray, in the treatment of seasonal allergic rhinitis, was compared in a large, placebo-controlled, two-center study. A 1-week baseline period was followed by a 4- to 6-week treatment period during which 635 adult patients, aged 18-72 years, were randomized to receive either placebo, budesonide 128 micrograms, or 256 micrograms once daily, or fluticasone propionate, 200 micrograms once daily. Nasal and eye symptoms, overall treatment efficacy and safety assessments were made during the study period. Combined, as well as individual, nasal symptoms were significantly improved in all three active treatment groups compared with placebo therapy. Treatment with 256 micrograms/day of budesonide was found to be significantly more effective in reducing the sneezing score compared with 200 micrograms/day of fluticasone propionate. Analysis of symptom scores on days when the pollen count was greater than 10 grains/m3 revealed 256 micrograms/day of budesonide therapy to be significantly more effective in reducing combined symptom scores as well as the individual scores for sneezing and runny nose, compared with 200 micrograms/day fluticasone propionate. The higher dose of budesonide (256 micrograms/day) was also more effective than the lower dose (128 micrograms/day) in reducing sneezing scores and statistical significance was almost reached for the reduction in combined symptom and runny nose scores. Substantial or total control of symptoms was achieved by 31.4%, 85.3%, 88.4%, and 81.9% of patients receiving placebo, 128 micrograms/day of budesonide, 256 micrograms/day of budesonide, and 200 micrograms/day of fluticasone propionate, respectively. The incidence of adverse events was low in all treatment groups. In conclusion, both budesonide and fluticasone propionate treatments were effective and well-tolerated in the treatment of seasonal allergic rhinitis. However, 256 micrograms/day of budesonide tended to be more effective than 200 micrograms/day of fluticasone propionate and 128 micrograms/day of budesonide, especially when patients were exposed to a higher pollen load.

Efficacy of an aqueous and a powder formulation of nasal budesonide compared in patients with nasal polyps.

Nasal polyps are commonly treated surgically. Intranasal administration of topical corticosteroids has gained increased acceptance as a treatment alternative. The aim of our study was to compare the efficacy of treatment of two formulations of budesonide with placebo on nasal polyps. At four Danish clinics 138 patients suffering from moderate or severe nasal polyps were randomized to a twice daily treatment with Rhinocort Aqua 128 micrograms, Rhinocort Turbuhaler 140 micrograms or placebo (Astra Draco, Sweden) for 6 weeks. Polyp size (primary efficacy variable), nasal symptoms, sense of smell, and patients' overall evaluation of treatment of efficacy were assessed by scores. Polyp size was reduced significantly in both budesonide treated groups compared with placebo, but there was no statistical difference between the two actively treated groups. Patients' nasal symptom scores was significantly more reduced in the Aqua compared to the Turbuhaler treated group, and both reduced symptom scores were significantly better compared to placebo. Sense of smell was significantly improved in the actively treated groups compared to placebo. The proportion of patients rating substantial or total control over symptoms after 6 weeks treatment was 60.9% and 48.2% in the Aqua and Turbuhaler-treated groups, respectively, which was significantly better compared with 29.8% in the placebo-treated group. Rhinocort Aqua and Rhinocort Turbuhaler were equally well tolerated.