Airway and systemic effects of soluble and suspension formulations of nebulized budesonide in asthmatic children

K. Basu, Arun Nair, Peter A. Williamson, Somnath Mukhopadhyay, Brian J. Lipworth

    Research output: Contribution to journalArticle

    11 Citations (Scopus)

    Abstract

    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 mu g twice daily, delivered via a nebulizer (eFlow), compared with a conventional budesonide suspension (Pulmicort Respules), 250 mu g twice daily, delivered via another nebulizer (LC Plus), using fraction of exhaled nitric oxide (FENO) 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 FENO 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 FENO, with no detectable difference between them when used in a putative microgram nominal dose ratio of 1:4. Neither formulation produced significant adrenal suppression. Ann Allergy Asthma Immunol. 2009; 103:436-441.

    Original languageEnglish
    Pages (from-to)436-441
    Number of pages6
    JournalAnnals of Allergy, Asthma & Immunology
    Volume103
    Issue number5
    DOIs
    Publication statusPublished - Nov 2009

    Keywords

    • Ether beta-cyclodextrin
    • Exhaled nitric oxide
    • Inhaled corticosteroids
    • Drug-delivery
    • Persistent asthma
    • Dry powder
    • In-vitro
    • Pharmacokinetics
    • Captisol(R)
    • Efficacy

    Cite this

    Basu, K. ; Nair, Arun ; Williamson, Peter A. ; Mukhopadhyay, Somnath ; Lipworth, Brian J. / Airway and systemic effects of soluble and suspension formulations of nebulized budesonide in asthmatic children. In: Annals of Allergy, Asthma & Immunology. 2009 ; Vol. 103, No. 5. pp. 436-441.
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    abstract = "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 mu g twice daily, delivered via a nebulizer (eFlow), compared with a conventional budesonide suspension (Pulmicort Respules), 250 mu g twice daily, delivered via another nebulizer (LC Plus), using fraction of exhaled nitric oxide (FENO) 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 FENO 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 FENO, with no detectable difference between them when used in a putative microgram nominal dose ratio of 1:4. Neither formulation produced significant adrenal suppression. Ann Allergy Asthma Immunol. 2009; 103:436-441.",
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    Airway and systemic effects of soluble and suspension formulations of nebulized budesonide in asthmatic children. / Basu, K.; Nair, Arun; Williamson, Peter A.; Mukhopadhyay, Somnath; Lipworth, Brian J.

    In: Annals of Allergy, Asthma & Immunology, Vol. 103, No. 5, 11.2009, p. 436-441.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - Airway and systemic effects of soluble and suspension formulations of nebulized budesonide in asthmatic children

    AU - Basu, K.

    AU - Nair, Arun

    AU - Williamson, Peter A.

    AU - Mukhopadhyay, Somnath

    AU - Lipworth, Brian J.

    PY - 2009/11

    Y1 - 2009/11

    N2 - 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 mu g twice daily, delivered via a nebulizer (eFlow), compared with a conventional budesonide suspension (Pulmicort Respules), 250 mu g twice daily, delivered via another nebulizer (LC Plus), using fraction of exhaled nitric oxide (FENO) 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 FENO 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 FENO, with no detectable difference between them when used in a putative microgram nominal dose ratio of 1:4. Neither formulation produced significant adrenal suppression. Ann Allergy Asthma Immunol. 2009; 103:436-441.

    AB - 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 mu g twice daily, delivered via a nebulizer (eFlow), compared with a conventional budesonide suspension (Pulmicort Respules), 250 mu g twice daily, delivered via another nebulizer (LC Plus), using fraction of exhaled nitric oxide (FENO) 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 FENO 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 FENO, with no detectable difference between them when used in a putative microgram nominal dose ratio of 1:4. Neither formulation produced significant adrenal suppression. Ann Allergy Asthma Immunol. 2009; 103:436-441.

    KW - Ether beta-cyclodextrin

    KW - Exhaled nitric oxide

    KW - Inhaled corticosteroids

    KW - Drug-delivery

    KW - Persistent asthma

    KW - Dry powder

    KW - In-vitro

    KW - Pharmacokinetics

    KW - Captisol(R)

    KW - Efficacy

    U2 - 10.1016/S1081-1206(10)60365-1

    DO - 10.1016/S1081-1206(10)60365-1

    M3 - Article

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    EP - 441

    JO - Annals of Allergy, Asthma & Immunology

    JF - Annals of Allergy, Asthma & Immunology

    SN - 1081-1206

    IS - 5

    ER -