Budesonide Inhalation Suspension Research Articles

Optimizing inhaled corticosteroid therapy in children with chronic asthma

Asthma is the most common chronic illness among children, and inhaled corticosteroids (ICS) are the most effective long-term therapy available for suppressing airway inflammation in persistent asthma. While the primary aim of ICS therapy is good efficacy with minimal side effects, early diagnosis and treatment of asthma can also improve asthma control and normalize lung function, and may prevent irreversible airway injury. Poor patient compliance is a major barrier to treatment. Simplified dosing regimens (e.g., once-daily administration), good inhaler technique, and education of the patient/caregiver should improve patient compliance. Concerns over ICS therapy are often based on the potential for systemic effects associated with oral corticosteroids (e.g., effects on bone mineral density, or growth suppression in children). Since adverse events are associated with high doses of ICS, the dose in all patients should be titrated to the minimum effective dose required to maintain control. Optimal distribution of an ICS in the lungs rather than the systemic compartment is affected by several factors, including the drug's pharmacokinetic profile, inhaler type, inhaler technique, and drug particle size. For young patients unable to use a dry-powder inhaler or pressurized metered-dose inhaler, a nebulizer facilitates drug delivery through passive inhalation; ICS therapy in the form of budesonide inhalation suspension can be given to children with persistent asthma from 12 months of age. In conclusion, selecting a drug with good efficacy and minimal side effects, such as budesonide, together with an easy-to-use delivery system and ongoing patient/caregiver education, is important in optimizing ICS therapy for children with persistent asthma.

Systemic availability and lung deposition of budesonide via three different nebulizers in adults

Budesonide is an inhaled corticosteroid widely used in the treatment of asthma. The local and systemic availability of budesonide has been determined in adults via pressurized metered-dose inhaler and dry-powder inhaler. To estimate lung deposition and systemic availability of budesonide inhalation suspension in healthy adults. Twelve adult volunteers entered an open, randomized, five-way crossover study and received the following treatments, with 1-week washout between treatments: separate 2-mg (nominal dose) budesonide doses via the Pari Inhalierboy (Inhalierboy; Pari GmbH, Starnberg, Germany), Pari LC Jet Plus (Jet Plus, Pari GmbH), and Maxin MA-2 (MA-2; Clinova Medical AB, Malmö, Sweden) jet nebulizers, 4 mg budesonide orally, and 0.5 mg budesonide intravenously. The plasma concentration of budesonide was measured up to 8 hours postadministration. Lung deposition and systemic availability of nebulized budesonide were estimated using pharmacokinetic evaluation. In this first study of the bioavailability of budesonide inhalation suspension in adults, there were no differences between nebulizers in lung deposition (14 to 16%) or systemic availability (15 to 17%) relative to the nominal budesonide dose. Relative to the actual dose inhaled (dose-to-subject), lung deposition and systemic availability were statistically significantly higher for the Jet Plus (58 and 63%, respectively) and MA-2 (59 and 64%, respectively) nebulizers than the Inhalierboy (36 and 44%, respectively). The Inhalierboy produced larger aerosol droplets than Jet Plus or MA-2 nebulizers (7-, 5-, and 3-microm mass median diameters, respectively) and delivered a higher dose-to-subject than the other two nebulizers. Relative to the nominal dose, lung deposition and systemic availability of budesonide were similar via the three nebulizers tested.

Budesonide Inhalation Suspension Reduces the Need for Emergency Intervention in Pediatric Asthma: A Named‐Patient Case Series

This report describes 15 children aged 10–35 months frequently hospitalized with uncontrolled asthma who were monitored for a mean of 26.9 months to assess the efficacy of budesonide inhalation suspension (AstraZeneca LP, Wilmington, DE) in reducing emergency interventions. Budesonide inhalation suspension was previously shown to relieve asthma symptoms, improve pulmonary function, and reduce rescue medication use in children as young as 6 months with mild to severe persistent asthma. We now show that ≥ 1 year of treatment with Budesonide inhalation suspension at doses between 0.25 and 1.5 mg/d decreased the burden of asthma. The mean number of hospitalizations caused by asthma or respiratory illness decreased from 1.8 ± 1.37 in the period before initiation of treatment with Budesonide inhalation suspension to 0.33 ± 0.62 during treatment. Likewise, the mean number of oral prednisone courses decreased from 8.1 ± 13.7 to 1.8 ± 2.1, and the mean number of acute respiratory illnesses requiring additional therapy decreased from 2.7 ± 2.3 before treatment with Budesonide inhalation suspension to 0.87 ± 0.74 during treatment. Numbers of emergency department visits decreased or remained the same after initiation of Budesonide inhalation suspension treatment in all but two children. There was no effect on growth rate in this group of children with moderate to severe asthma. In this case series, Budesonide inhalation suspension represents a safe, effective treatment option to prevent recurrent emergency intervention for patients < 3 years of age with poorly controlled asthma.

Effect of High Starting Dose of Budesonide Inhalation Suspension on Serum Cortisol Concentration in Young Children with Recurrent Wheezing Episodes

Introduction. There are no available data on the safety of recommended schedules for the initiation of treatment with budesonide inhalation suspension in children with recurrent wheezing episodes. We compared the safety of high and low starting dose of budesonide by measuring their effect on plasma cortisol concentration. Methods. A randomized double-blind, placebo-controlled design was used. Twenty-nine children ages 6 months to 3 years were divided into three groups: (1) high starting dose: 1 mg budesonide inhalation suspension twice daily followed by a stepwise decrease of 25% every second day for 8 days (n = 11); (2) low starting dose: 0.25 mg twice daily for 8 days (n = 11); (3) placebo (n = 7). The 8 AM (fasting) and 1-hour post-ACTH stimulation plasma cortisol concentrations were measured before and 10 days after initiation of budesonide treatment. Results. Before treatment and after 8–10 days of treatment, there was no significant difference in mean serum cortisol concentration in the high starting dose, low-dose and placebo groups, either at 8 AM or at 1 hour after ACTH stimulation. Conclusion. The administration of nebulized suspension of budesonide at a high starting dose (2 mg/day for 2 days) followed by a rapid stepwise decrease over 8 days was safe, causing similar changes in serum cortisol levels to low-dose budesonide suspension or placebo.

Effective Once-Daily Administration of Budesonide Inhalation Suspension by Nebulizer with Facemasks or Mouthpieces for Persistent Asthma in Infants and Young Children

Purpose of the Study. A retrospective analysis comparing the efficacy and safety of nebulized budesonide inhalation suspension (Pulmicort Respules, AstraZeneca, Lund, Sweden) administered once daily by facemask or mouthpiece for mild persistent asthma. Study Population. A total of 359 children aged 6 months to 8 years with mild, persistent asthma. Methods. Children were randomized to receive 0.25, 0.5, or 1.0 …

Budesonide inhalation suspension: A nebulized corticosteroid for persistent asthma

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. (J Allergy Clin Immunol 2002;109:730-42.)

Effects of budesonide inhalation suspension on hypothalamic-pituitary-adrenal-axis function in infants and young children with persistent asthma

The initial 12-week, double-blind phases of three studies demonstrated that budesonide inhalation suspension (BIS) is effective and well tolerated in infants and young children (6 months to 8 years of age) with persistent asthma. Open-label, 52-week extensions to these studies were conducted to evaluate long-term safety of BIS, including effects of treatment with the lowest effective dose of BIS on hypothalamic-pituitary-adrenal (HPA)-axis function, as compared with conventional asthma therapy (CAT). Complete results of the earlier phases of the studies and of long-term safety are reported elsewhere; only results pertaining to HPA-axis function are summarized here. Patients eligible for the open-label phases of the three trials were randomized to treatment with nebulized BIS (n = 447) or CAT (n = 223). CAT included short-acting oral or inhaled beta2-agonists, methylxanthines, or cromolyn sodium; in two of the studies, CAT could have included other inhaled corticosteroids. HPA-axis function, which had been evaluated during the 12-week double-blind studies, was again evaluated at the beginning and end of the 52-week study period using basal plasma cortisol concentrations and response to stimulation with a 250-microg dose of adrenocorticotropic hormone. There was no evidence of altered HPA-axis function attributable to BIS treatment. No clinically or statistically significant differences in basal or adrenocorticotropic hormone-stimulated plasma cortisol concentrations were observed between BIS and CAT in either the 12-week, double-blind or 52-week, open-label phases of the three studies. The results indicate that treatment with BIS does not result in clinically significant suppression of HPA-axis function in infants and young children.

Role of budesonide inhalation suspension in children with asthma.

To evaluate the role of budesonide inhalation suspension (BIS) in the treatment of children with asthma. Literature identified through Medline (1966-November 2000) and references obtained from selected articles. Search terms included budesonide and asthma. Asthma is a chronic inflammatory disease that affects approximately 4.8 million children in the US. By reducing inflammation, corticosteroids decrease symptoms and improve lung function. As the first nebulized corticosteroid, BIS offers an important treatment option for children with persistent asthma. BIS is effective in reducing symptoms and improving lung function in children with asthma. It should be used in children ages 1-8 years with moderate to severe persistent asthma who are unable to effectively use a metered-dose inhaler with or without a spacer or a dry-powder inhaler.

Role of Budesonide Inhalation Suspension in Children with Asthma

OBJECTIVE:To evaluate the role of budesonide inhalation suspension (BIS) in the treatment of children with asthma.DATA SOURCES:Literature identified through Medline (1966–November 2000) and references obtained from selected articles. Search terms included budesonide and asthma.DATA SYNTHESIS:Asthma is a chronic inflammatory disease that affects approximately 4.8 million children in the US. By reducing inflammation, corticosteroids decrease symptoms and improve lung function. As the first nebulized corticosteroid, BIS offers an important treatment option for children with persistent asthma.CONCLUSIONS:BIS is effective in reducing symptoms and improving lung function in children with asthma. It should be used in children ages 1–8 years with moderate to severe persistent asthma who are unable to effectively use a metered-dose inhaler with or without a spacer or a dry-powder inhaler.

Low frequency of adverse events reported through postmarketing surveillance for pulmicort respulesTM (budesonide inhalation suspension) in the US adult population

Low frequency of adverse events reported through postmarketing surveillance for pulmicort respulesTM (budesonide inhalation suspension) in the US adult population

Twice-Daily Budesonide Inhalation Suspension in Infants and Children

A retrospective analysis, based on a randomized, placebo-controlled, 12-week study in children 6 months to 8 years of age with persistent asthma, was performed to compare the efficacy and safety of budesonide inhalation suspension 0.25 mg and 0.5 mg twice daily vs. placebo in children <4 and ≥4 years of age. Both age groups demonstrated significant (p ≤ 0.050) improvement in nighttime and daytime asthma symptom scores and decreased bronchodilator use compared with placebo. In addition, the safety profile of twice-daily budesonide inhalation suspension was favorable in both age groups.

Safety of pulmicort respulesTM (budesonide inhalation suspension) in geriatric patients: Postmarketing surveillance and clinical study data

Safety of pulmicort respulesTM (budesonide inhalation suspension) in geriatric patients: Postmarketing surveillance and clinical study data

Efficacy of budesonide inhalation suspension (pulmicort respulesTM) in children with asthma previously treated with inhaled corticosteroids or other daily medications

Efficacy of budesonide inhalation suspension (pulmicort respulesTM) in children with asthma previously treated with inhaled corticosteroids or other daily medications

Once-daily budesonide inhalation suspension in infants and children

Budesonide inhalation suspension (Pulmicort Respules; AstraZeneca LP, Wilmington, DE), a nebulized corticosteroid, was developed for use in infants and young children with persistent asthma. To compare the efficacy and safety of once-daily budesonide inhalation suspension in children < 4 years of age and in those > or = 4 years of age with persistent asthma. A retrospective analysis stratified by age group was performed on data from two randomized, double-blind, placebo-controlled, parallel-group studies that evaluated the efficacy and safety of budesonide inhalation suspension 0.25 mg, 0.5 mg, or 1.0 mg once daily for 12 weeks in children 6 months to 8 years of age with persistent asthma. Clinical assessments included nighttime and daytime asthma symptoms, breakthrough medication use, adverse events, and hypothalamic-pituitary-adrenal-axis function. In both randomized studies, budesonide inhalation suspension demonstrated statistically significant improvement in nighttime and daytime asthma symptom scores compared with placebo. In the retrospective analysis of pooled data from these studies, the efficacy of budesonide was maintained when children were stratified by age group. Clinical improvements from baseline in nighttime and daytime asthma symptom scores were observed in both age groups at all budesonide inhalation suspension dose levels. No significant differences were observed between age groups in breakthrough medication use in any of the treatment groups. No differences were observed in the incidence of adverse events between the two age groups, and significant (P < 0.01) effect on hypothalamic-pituitary-adrenal-axis function was apparent only in children < 4 years of age at the 0.25-mg dose level. Once-daily budesonide inhalation suspension is effective in the treatment of persistent asthma in children aged < 4 and > or = 4 years of age.

Effective Once-Daily Administration of Budesonide Inhalation Suspension by Nebulizer with Facemasks or Mouthpieces for Persistent Asthma in Infants and Young Children

This study is a retrospective analysis comparing nebulized budesonide inhalation suspension (BIS; Pulmicort Respules™, AstraZeneca, Wilmington, DE) administered once daily by facemask or mouthpiece...

A review of budesonide inhalation suspension in the treatment of pediatric asthma.

Asthma is recognized as an inflammatory disease, and inhaled corticosteroids are the mainstay of treatment in patients with persistent disease. Until recently, no inhaled corticosteroid was approved in the United States for children aged 4 years and younger, and no practical dosage form was available for infants and young children unable to use metered-dose inhalers effectively. Budesonide inhalation suspension (BIS) is a glucocorticoid with high topical and low systemic activity. In children aged 12 months-8 years, BIS improves asthma symptoms and lung function and decreases the need for breakthrough bronchodilators. Long-term follow-up studies in children concluded that BIS is well tolerated, with little or no effect on growth and hypothalamic-pituitary-adrenal axis function. Thus it is a valuable therapeutic alternative to systemic corticosteroid therapy in infants and young children.

Methylphenidate Extended-Release Tablets

Each month, subscribers to The Formulary® Monograph Service receive five to six researched monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board called The Formulary Information Exchange (The F.I.X). All topics pertinent to clinical pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The December 2000 Formulary monographs are budesonide inhalation suspension, arsenic trioxide, sodium phosphate, ziprasidone, and unoprostone. The DUE is on budesonide inhalation suspension.

Methylphenidate Extended-Release Tablets

Each month, subscribers to The Formulary® Monograph Service receive five to six researched monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board called The Formulary Information Exchange (The F.I.X). All topics pertinent to clinical pharmacy are discussed on The F.I.X. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The December 2000 Formulary monographs are budesonide inhalation suspension, arsenic trioxide, sodium phosphate, ziprasidone, and unoprostone. The DUE is on budesonide inhalation suspension.

Budesonide inhalation suspension: a review of its use in infants, children and adults with inflammatory respiratory disorders.

Budesonide, a topically active corticosteroid, has a broad spectrum of clinically significant local anti-inflammatory effects in patients with inflammatory lung diseases including persistent asthma. In infants and young children with persistent asthma, day- and night-time symptom scores, and the number of days in which beta2-agonist bronchodilators were required, were significantly lower during randomised, double-blind treatment with budesonide inhalation suspension 0.5 to 2 mg/day than placebo in 3 multicentre trials. Significantly fewer children discontinued therapy with budesonide inhalation suspension than with placebo because of worsening asthma symptoms in a study that included children who were receiving inhaled corticosteroids at baseline. Recent evidence indicates that budesonide inhalation suspension is significantly more effective than nebulised sodium cromoglycate in improving control of asthma in young children with persistent asthma. At a dosage of 2 mg/day, budesonide inhalation suspension significantly reduced the number of asthma exacerbations and requirements for systemic corticosteroids in preschool children with severe persistent asthma. In children with acute asthma or wheezing, the preparation was as effective as, or more effective than oral prednisolone in improving symptoms. In children with croup, single 2 or 4mg dosages of budesonide inhalation suspension were significantly more effective than placebo and as effective as oral dexamethasone 0.6 mg/kg or nebulised L-epinephrine (adrenaline) 4mg in alleviating croup symptoms and preventing or reducing the duration of hospitalisation. Early initiation of therapy with budesonide inhalation suspension 1 mg/day appears to reduce the need for mechanical ventilation and decrease overall corticosteroid usage in preterm very low birthweight infants at risk for chronic lung disease. In adults with persistent asthma, budesonide inhalation suspension < or =8 mg/day has been compared with inhaled budesonide 1.6 mg/day and fluticasone propionate 2 mg/day administered by metered dose inhaler. Greater improvements in asthma control occurred in patients during treatment with budesonide inhalation suspension than with budesonide via metered dose inhaler, whereas fluticasone propionate produced greater increases in morning peak expiratory flow rates than nebulised budesonide. Several small studies suggest that the preparation has an oral corticosteroid-sparing effect in adults with persistent asthma and that it may be as effective as oral corticosteroids during acute exacerbations of asthma or chronic obstructive pulmonary disease. The frequency of adverse events was similar in children receiving budesonide inhalation suspension 0.25 to 2 mg/day or placebo in 12-week studies. During treatment with budesonide inhalation suspension 0.5 to 1 mg/day in 3 nonblind 52-week studies, growth velocity in children was generally unaffected; however, a small but statistically significant decrease in growth velocity was detected in children who were not using inhaled corticosteroids prior to the introduction of budesonide inhalation suspension. Hypothalamic-pituitary-adrenal axis function was not affected by short (12 weeks) or long (52 weeks) term treatment with nebulised budesonide. In conclusion, budesonide inhalation suspension is the most widely available nebulised corticosteroid, and in the US is the only inhaled corticosteroid indicated in children aged > or =1 year with persistent asthma. The preparation is suitable for use in infants, children and adults with persistent asthma and in infants and children with croup.

Longitudinal growth in infants and young children treated with budesonide inhalation suspension for persistent asthma

Background: Results of recent growth studies suggest that inhaled glucocorticosteroids may affect growth in children. Objective: Three 52-week, open-label extension studies (studies A, B, and C) were conducted to compare the effects of budesonide inhalation suspension (BIS) with conventional asthma therapy (CAT) on long-term safety, including intermediate-term growth, in 3 different pediatric asthma populations. Methods: Pediatric asthma patients (ages 6 months to 8 years) from 3 multicenter, randomized, 12-week, double-blind, placebo-controlled studies were eligible to enroll in the 52-week, open-label extension studies. The extension studies were multicenter, randomized, open-label, active-controlled, parallel-group studies performed at 26 centers in the United States. Subjects in each extension study were randomized in a 2:1 ratio to receive either BIS or CAT. BIS was initially administered at a dose of 0.5 mg once (studies A and C) or twice daily (study B), with attempts made at each clinical visit to gradually reduce the dose to the minimum effective dose that maintains asthma control, as judged by the investigator. CAT consisted of any available therapy for asthma, including inhaled glucocorticosteroids in studies B and C only. Height SD scores, growth velocity, and skeletal age (only in studies B and C) were examined. Results: In total, 670 subjects were randomized; 223 subjects received CAT and 447 received BIS. Mean ages at entry were 63.0 months and 60.9 months in CAT and BIS groups, respectively. Median total daily doses of BIS ranged from 0.5 to 1.0 mg and the mean duration of treatment exposure was 304 ± 119 days and 342 ± 83 days in CAT and BIS groups, respectively. Changes in height SD scores differed significantly between the BIS and CAT groups in study A (–0.19, P = .003), and there was a small, statistically significant decrease in growth velocity (–0.8 cm/y, P = .002) in the BIS-treated group compared with the CAT group. No significant differences were observed between BIS and CAT groups in the changes in height SD scores or in growth velocities in studies B (+0.10 and +0.7 cm/y, respectively) and C (+0.12 and +0.8 cm/y, respectively). No differences in skeletal age were observed between BIS and CAT groups in studies B and C. Conclusion: There was a small, statistically significant decrease in growth velocity in the BIS-treated group compared with the CAT group in the study (study A) where inhaled glucocorticosteroid use was prohibited before entry and in the CAT group during the study. In the studies (B and C) where inhaled glucocorticosteroids were allowed in the CAT group, no differences were observed in height SD scores or growth velocity. The clinical relevance of these effects, including impact on final adult height, remain to be determined in prospectively planned studies that assess growth in children. (J Allergy Clin Immunol 2000;105:259-68.)