BACKGROUND: 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.
RCT Entities:
BACKGROUND: 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.
Authors: Victoria A Wickenheisser; Emilia Marta Zywot; Emily Mary Rabjohns; Hyun Ho Lee; David S Lawrence; Teresa Kathleen Tarrant Journal: Curr Allergy Asthma Rep Date: 2019-07-02 Impact factor: 4.806