Efficacy Of Budesonide Inhalation Suspension Research Articles

Budesonide inhalation suspension versus methylprednisolone for treatment of moderate bronchial asthma attacks

Background Owing to their side effects, administration of steroids for bronchial asthma attacks should be minimized. We investigated whether budesonide inhalation suspension (BIS) could replace intravenous steroid administration for the treatment of moderate bronchial asthma attacks.Subjects and Methods The subjects were children aged 5 years and younger hospitalized for moderate bronchial asthma attacks. Patients were randomly assigned to one of two groups: 20 patients received methylprednisolone (mPSL) and 20 were treated with BIS. The mPSL group began treatment with inhalation of procaterol hydrochloride (0.3 mL) and disodium cromoglycate (2 mL) three times a day and systemic administration of mPSL (1 mg/kg) three times a day. The BIS group began treatment with inhalation of procaterol hydrochloride (0.3 mL) and BIS (0.5 mg) three times a day. The frequency of inhalations and steroid administration was adjusted according to the severity of symptoms. The cortisol level at discharge was measured.Results There were no significant differences between the two groups in terms of the severity of attacks and duration of management, or in terms of therapeutic efficacy, duration of wheezing, or period of hospitalization. The frequency of inhalations on days 3 to 6 of hospitalization was lower in the BIS group than in the mPSL group, and the cortisol level at discharge was significantly higher in the BIS group (13.9 ± 6.1 μg/dL) than in the mPSL group (8.0 ± 2.1 μg/dL) (p = 0.008).Conclusion In patients with recurrent wheezing or bronchial asthma of <5 years, the efficacy of BIS is equivalent or better than mPSL for moderate bronchial asthma attacks, and in contrast to steroid treatment, BIS treatment do not suppress adrenocortical function.

Prophylactic effectiveness of budesonide inhalation in reducing postoperative throat complaints

Postoperative sore throat (POST) is one of the main postoperative complaints. This study was to evaluate the efficacy of budesonide inhalation suspension (BIS) in reducing the incidence and severity of POST. One hundred and twenty patients scheduled for thyroid surgery with general anesthesia were enrolled and randomized into three groups. Group A received 200mcg BIS 10min prior to the tracheal intubation and received the same treatment 6 and 24h after extubation. Group B received 200mcg BIS 6 and 24h after extubation. Control group received the same scheduled treatment as Group A, but the BIS was replaced with 2ml normal saline. The patients were evaluated for sore throat and hoarseness 1, 24 and 48h after extubation. The status of laryngopharynx was also recorded. There was no statistically significant difference in the incidence of sore throat among three groups. However, hoarseness occurred significantly less frequently in Group A (P<0.05). Onehour after extubation, Group A exhibited significantly less severe sore throat and hoarseness compared to the other two groups (P<0.05), which disappeared 24h later. The mucositis scores of laryngopharynx at 1, 24 and 48h post-extubation were significantly lower in Group A (P<0.05). BIS can reduce the incidence and severity of the POST prophylactically.

Comparative Study of Budesonide Inhalation Suspension and Montelukast in Young Children With Mild Persistent Asthma

Szefler SJ, Baker JW, Uryniak T, Goldman M, Silkoff PE. J Allergy Clin Immunol. 2007;120(5):1043–1050 PURPOSE OF THE STUDY. To evaluate the efficacy of budesonide inhalation suspension (Pulmicort respules) compared with montelukast (Singulair) for controlling asthma symptoms in young children with mild persistent asthma. STUDY POPULATION. This was a prospective study of 395 children, aged 2 to 8 years, diagnosed with mild persistent asthma recruited from 55 US centers. Approximately 12% of the subjects had previous histories of inhaled corticosteroid (ICS) use. METHODS. Subjects were randomly assigned to receive either budesonide 0.5 mg or montelukast 4 to 5 mg daily and were followed for 52 weeks. Compliance was assessed by daily electronic diary review. For mild asthma exacerbations, step-up therapy consisted of the addition of a morning dose of budesonide 0.5 mg in both arms. For severe asthma exacerbations, subjects received a 3- to 10-day standardized course of oral steroids. The primary end point was evaluated by using the intention-to-treat population and was defined as time to first additional medication for asthma worsening at 52 weeks. Secondary end points included the time to additional asthma medication and rates of occurrence of mild and severe asthma exacerbations. Changes in symptom scores, peak flows, rescue-medication use, and pulmonary-function test results were also evaluated. RESULTS. Kaplan-Meier probability curves showed that the primary outcome measurement, time to the first additional asthma medication, was not significantly different between the 2 groups at 52 weeks (P = .3). There was a significant increase in the time to first additional asthma medication in the budesonide group compared with the montelukast group at 12 weeks (P = .05). The percentage of subjects requiring step-up therapy in the budesonide group versus the montelukast group at 12 weeks was 29.1% versus 38.6% (not significant [NS]), at 26 weeks was 41.3% versus 48.2% (NS), and at 52 weeks was 52% versus 56.9% (NS), respectively. The budesonide group achieved significantly improved morning and evening peak flow values compared with the montelukast group at 12 weeks (P = .005–.007). The rate of mild and severe asthma exacerbations per subject per year in the budesonide and montelukast groups was 1.23 and 1.63, respectively (P = .034). There was no significant difference in the number of severe asthma exacerbations between the 2 groups. Both treatment groups showed nonsignificant improvements in changes from baseline asthma scores, 24-hour rescue-medication use, and medication- and asthma-free days. CONCLUSIONS. Both budesonide and montelukast are effective and well-tolerated as controller medications in children aged 2 to 8 years with mild persistent asthma. Results favored budesonide for several secondary outcome measures. REVIEWER COMMENTS. Previous studies have shown that ICSs are more effective asthma-controller medications compared with montelukast in children older than 6 years. Although this study failed to show statistical significance in the primary outcome, it provides data supporting certain treatment benefits of ICSs in children younger than 6 years (257 of 395 children were &amp;lt;5 years old). Compared with previous studies, these children had milder asthma, with only 12% having taken ICSs before enrollment.

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.

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.)

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

Efficacy of budesonide inhalation suspension in infants and young children with persistent asthma

This paper reviews the results from 3 randomized, double-blind, placebo-controlled, multicenter studies that assessed the efficacy and safety of once- and twice-daily dosing of budesonide inhalation suspension (BIS) in infants and young children with persistent asthma. In children with mild persistent asthma that was previously treated with bronchodilators or noncorticosteroid anti-inflammatory agents (study A), nighttime and daytime asthma symptoms were significantly improved in 0.25-mg once daily, 0.5-mg once daily, and 1.0-mg once daily BIS treatment groups compared with placebo ( P ≤ .05). Rescue medications were used significantly less in all BIS groups (approximately 2 days of every 14 days) compared with placebo ( P < .05). The proportion of patients who discontinued this therapy because of worsening asthma was greater in the placebo group than in the BIS groups, with the difference between placebo (23%) and the 1.0-mg BIS group (13%) being statistically significant ( P = .020). All BIS doses except 0.5 mg once daily showed nonsignificant numeric improvement in morning and evening peak expiratory flow (PEF) compared with placebo. In children with asthma that was previously treated with inhaled corticosteroids (study B), BIS doses of 0.25 mg, 0.5 mg, and 1.0 mg twice daily resulted in significant improvements in nighttime symptoms scores versus placebo ( P ≤ .026). Rescue medications were used significantly less in all BIS groups (approximately 2.5 to 3.5 days of every 14 days) compared with placebo ( P ≤ .032). The proportion of patients receiving placebo who discontinued therapy because of worsening asthma symptoms (36%) was significantly greater compared with the BIS groups (9%; P ≤ .015). Morning PEF levels were significantly greater in each BIS group compared with placebo ( P ≤ .03). For evening PEF levels, all BIS treatment groups showed numeric improvements compared with placebo; the 0.25-mg twice daily budesonide group showed statistically significant improvement ( P < .05). In children with moderate persistent asthma that was previously maintained either on bronchodilators or inhaled corticosteroids (study C), nighttime asthma symptoms significantly improved in the 0.25-mg twice daily, 0.5-mg twice daily, and 1.0-mg once daily BIS groups compared with placebo ( P < .01); there was a numeric improvement for the 0.25-mg once daily treatment group. Rescue medications were used significantly less in all BIS groups (approximately 2 to 3 days of every 14 days) compared with placebo ( P ≤ .014). The proportion of patients who discontinued treatment because of worsening of asthma symptoms was greater in the placebo group than in the BIS groups; the difference between 0.25-mg twice daily group (13%) and the placebo group (26%) was statistically significant ( P = .029). All BIS doses showed numeric improvement in morning PEF levels, and statistically significant improvements were observed in the 0.25-mg twice daily, 0.5-mg twice daily, and 1.0-mg once daily groups compared with placebo ( P < .03). Significant improvements in evening PEF levels were observed for each BIS treatment group ( P ≤ .034), except for the 1.0-mg once daily group. Overall, the 3 studies show that once- and twice-daily dosing of BIS effectively relieves asthma symptoms and improves pulmonary function in infants and young children with mild-to-severe persistent asthma. (J Allergy Clin Immunol 1999;104:S191-9)

Study designs and challenges in clinical studies conducted in infants and children with asthma

Because of the challenges associated with conducting clinical trials in pediatric patients, most drugs have not been adequately tested in this patient population. Insufficient testing frequently results in product labeling that fails to provide instructions for safe and effective use in pediatric patients. The most prevalent chronic disease in children is asthma; however, very few asthma medications have been evaluated in infants and young children. Budesonide inhalation suspension is an anti-inflammatory corticosteroid administered by nebulization that requires only passive inhalation and is therefore suitable for infants and young children who are unable to use currently available inhalation devices for the administration of asthma medications. The efficacy of budesonide inhalation suspension was evaluated in 3 US clinical trials. All 3 trials were randomized, controlled, double-blind, 12-week studies in children (6 months–8 years of age) with a primary diagnosis of chronic persistent asthma. Symptom assessments conducted in both the morning and evening were the primary efficacy variables. Although the children were young, secondary efficacy evaluations included spirometry and peak expiratory flow collected in both the morning and evening (in a subset of patients capable of performing these maneuvers). Patients who completed or were discontinued from the 12-week double-blind treatment phase were eligible to enter 52-week, open-label extension studies. The design of these 3 studies confirms the feasibility of the performance of placebo-controlled clinical trials of asthma medications in pediatric patients and allows for efficacy evaluations based on symptom assessments together with pulmonary function testing. (J Allergy Clin Immunol 1999;104:S184-90)