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

doi:10.1016/S1081-1206(10)60365-1

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 journal › Article › peer-review

13 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 language	English
Pages (from-to)	436-441
Number of pages	6
Journal	Annals of Allergy, Asthma and Immunology
Volume	103
Issue number	5
DOIs	https://doi.org/10.1016/S1081-1206(10)60365-1
Publication status	Published - Nov 2009

Keywords

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

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10.1016/S1081-1206(10)60365-1

http://www.annallergy.org/article/S1081-1206%2810%2960365-1/abstract

Cite this

@article{cd9861e042b349f1bea8682b1d0a0d10,

title = "Airway and systemic effects of soluble and suspension formulations of nebulized budesonide in asthmatic children",

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.",

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

author = "K. Basu and Arun Nair and Williamson, {Peter A.} and Somnath Mukhopadhyay and Lipworth, {Brian J.}",

year = "2009",

month = nov,

doi = "10.1016/S1081-1206(10)60365-1",

language = "English",

volume = "103",

pages = "436--441",

journal = "Annals of Allergy, Asthma and Immunology",

issn = "1081-1206",

publisher = "Elsevier",

number = "5",

}

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

SN - 1081-1206

VL - 103

SP - 436

EP - 441

JO - Annals of Allergy, Asthma and Immunology

JF - Annals of Allergy, Asthma and Immunology

IS - 5

ER -

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

Abstract

Keywords

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