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Published on: November 5, 2010
Budesonide inhalation suspension: a nebulized corticosteroid for persistent asthma
Stanley J Szefler1, Howard Eigen
1National Jewish Medical and Research Center, Denver, USA.
Insights
Budesonide inhalation suspension offers an effective and well-tolerated treatment for persistent asthma in young children. This nebulizer-delivered inhaled corticosteroid is approved for infants and improves lung function and symptoms.
Area of Science:
- Pediatric Pulmonology
- Allergy and Immunology
- Pharmacology
Background:
- Current guidelines recommend inhaled corticosteroids for persistent pediatric asthma.
- Traditional inhaler devices pose challenges for young children's correct usage.
- Limited inhaled corticosteroid options were approved for children under 4 years.
Purpose of the Study:
- To introduce budesonide inhalation suspension as a novel treatment for infants and young children with persistent asthma.
- To highlight its suitability for nebulizer administration, addressing previous device limitations.
- To present US-based clinical trial data on its efficacy and tolerability.
Main Methods:
- Three placebo-controlled, multicenter trials were conducted in the United States.
- Budesonide inhalation suspension was administered via nebulizer.
- Dosing regimens included once- and twice-daily administration of 0.25-1 mg.
Main Results:
- Budesonide inhalation suspension demonstrated significant improvements in pulmonary function.
- Asthma symptoms were ameliorated in infants and young children with persistent asthma.
- The suspension was well-tolerated, with adverse event rates comparable to placebo and conventional therapies.
Conclusions:
- Budesonide inhalation suspension is an effective and safe inhaled corticosteroid for managing persistent asthma in young children.
- Its approval for infants as young as 12 months and nebulizer delivery addresses critical unmet needs.
- Clinical trials confirm its tolerability and efficacy, supporting its use in this population.
Abstract:
Guidelines for managing asthma in pediatric patients published by the American Academy of Allergy, Asthma, and Immunology and the American Academy of Pediatrics recommend the use of inhaled corticosteroids for the management of persistent asthma in infants and young children. When these guidelines were published, pressurized metered-dose inhalers and dry-powder inhalers were the only delivery devices available for inhaled corticosteroids in the United States. These devices can be difficult for young children to use correctly. Furthermore, no inhaled corticosteroid was approved in the United States for the treatment of children younger than 4 years. Budesonide inhalation suspension (Pulmicort Respules; AstraZeneca LP, Wilmington, Del) was developed to meet the medication delivery needs of infants and young children with persistent asthma. Pulmicort Respules is the first inhaled corticosteroid approved for administration by means of a nebulizer and the only inhaled corticosteroid approved in the United States for infants as young as 12 months. Budesonide has been studied extensively worldwide. In the United States the tolerability and efficacy of budesonide inhalation suspension were confirmed in 3 placebo-controlled multicenter trials. These studies demonstrated that both once- and twice-daily dosing of budesonide inhalation suspension (0.25-1 mg) improved pulmonary function and ameliorated asthma symptoms in infants and young children with persistent asthma. Budesonide inhalation suspension was well tolerated, and the incidences of reported adverse events were similar among patients in the budesonide, placebo, and conventional asthma therapy groups. This article reviews the results of these studies, as well as the pharmacokinetics, pharmacodynamics, and clinical use of budesonide inhalation suspension.
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