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Airway and systemic effects of soluble and suspension formulations of nebulized budesonide in asthmatic children
journal contribution
posted on 2023-06-08, 14:03 authored by Kaninika Basu, Arun Nair, Peter A Williamson, Somnath MukhopadhyaySomnath Mukhopadhyay, Brian J LipworthBACKGROUND Using cyclodextrin with budesonide enables it to be formulated in a solution for nebulization. OBJECTIVE To observe the effects of a Captisol-enabled budesonide solution (CBIS), 60 microg twice daily, delivered via a nebulizer (eFlow), compared with a conventional budesonide suspension (Pulmicort Respules), 250 microg twice daily, delivered via another nebulizer (LC Plus), using fraction of exhaled nitric oxide (FE(NO)) and overnight urinary cortisol to creatinine ratio as the primary outcomes for efficacy and systemic bioactivity. METHODS A randomized, open-label, crossover study was conducted in 12 children with mild-to-moderate persistent asthma (aged 5-12 years). Measurements were performed after a 2-week steroid washout at baseline and at the end of each 2-week randomized treatment. RESULTS The nebulization time was shorter (95% confidence interval [CI], 0.83-5.63 minutes; P = .03) with CBIS (mean, 1.77 minutes) than with Pulmicort Respules (mean, 5.01 minutes). The reduction in FE(NO) with CBIS from pooled baseline was 2.45-fold (95% CI, 1.87-3.21; P < .001); and with Pulmicort Respules, 3.18-fold (95% CI, 2.26-4.47; P < .001). No statistically significant changes from pooled baseline in lung function and overnight urinary cortisol to creatinine ratio were observed with either treatment. CONCLUSIONS The nebulization time was shorter with CBIS compared with Pulmicort Respules. Both formulations exhibited similar anti-inflammatory activity in terms of reducing FE(NO), with no detectable difference between them when used in a putative microgram nominal dose ratio of 1:4. Neither formulation produced significant adrenal suppression
History
Publication status
- Published
Journal
Annals of Allergy, Asthma and ImmunologyISSN
1081-1206Publisher
ElsevierExternal DOI
Issue
5Volume
103Page range
436-441Department affiliated with
- Clinical and Experimental Medicine Publications
Full text available
- No
Peer reviewed?
- Yes
Legacy Posted Date
2012-12-03Usage metrics
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