Efficacy of an Aqueous and a Powder Formulation of Nasal Budesonide Compared in Patients with Nasal Polyps

Abstract

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.

Sinus Surgery and Delivery Method Influence the Effectiveness of Topical Corticosteroids for Chronic Rhinosinusitis: Systematic Review and Meta-Analysis

“…For 27 trials (56.3%), 17,19,20,26,30,33,34,[37][38][39]43,[46][47][48]50,[52][53][54][55][56][57][58][59][60][61][62]64 patients (all or the majority) had sinus surgery before administering steroid either as a cointervention or they had previous surgery documented. In 15 (31.3%) studies, 18 …”

Allergic rhinitis-induced nasal congestion: its impact on sleep quality

“…93 To date, however, there have been only a few published studies focusing on INS treatment outcomes in nasal polyposis. Small short-term studies from the 1990s examined the use of aqueous and powder forms of budesonide [97][98][99] and found it to be efficacious in the treatment of small-to largesized polyps. Other studies in patients with severe or bilateral polyposis found evidence of similar efficacy and tolerability of fluticasone propionate or beclomethasone dipropionate, with some evidence that fluticasone had a more rapid onset of action.…”

Evidence-Based Management of Nasal Polyposis by Intranasal Corticosteroids: From the Cause to the Clinic

“…Several randomized clinical trials have shown these medications to be effective treatments for NP (table 1) [8,13,64,65,66,67,68,69,70,71,72,73,74,75,76]. There are few or no randomized, controlled published trials that evaluate the effectiveness of the INSs flunisolide, triamcinolone, or beclomethasone in polyposis [77].…”

“…Similarly, budesonide aqueous suspension spray and/or topical powder has been associated with significant improvement in symptoms of congestion/obstruction at 4 weeks [68], 6 weeks [70], and 12 weeks [66,67], with dosages of 200/400 µg twice daily, 128 µg twice daily, and 200 µg twice daily, respectively. Study design and results for polyp size and/or number varied among studies.…”

“…These were shown to be effective in reducing nasal symptoms (nasal blockage, secretion, sneezing, and rhinitis) and improving peak nasal inspiratory flow (PNIF) over study periods ranging from 3 to 16 weeks [13,14,68,69,70,71,72,73,75,76,78]. …”