Nebulized Budesonide Research Articles

Budesonide nebulization added to systemic prednisolone in the treatment of acute asthma in children: a double-blind, randomized, controlled trial.

AA Alangari, N Malhis, M Mubasher. Chest. 2014;145(4):772–778 The goal of the study was to test the hypothesis that adding high-dose nebulized budesonide to standard asthma treatment in children in the emergency department (ED) during the first hour would decrease their hospital admission rate. The study population included children aged 2 to 12 years with physician-diagnosed asthma (or previous episodes of shortness of breath responsive to a β-agonist) who presented to the ED with a moderate or severe acute asthma exacerbation. Children were randomized within …

Budesonide Nebulization Added to Systemic Prednisolone in the Treatment of Acute Asthma in Children: A Double-Blind, Randomized, Controlled Trial

Inhaled corticosteroids, known to be effective as a maintenance medication in chronic asthma, have also been suggested as a therapy for acute asthma when given at high doses. A double-blind, randomized, placebo-controlled trial was conducted in children aged 2 to 12 years with moderate or severe acute asthma, as determined based on a clinical score of 5 to 15 points, where 15 is the most severe. We compared the addition of budesonide 1,500 μg vs placebo to standard acute asthma treatment, which included salbutamol, ipratropium bromide, and a single dose of prednisolone 2 mg/kg given at the beginning of therapy. The primary outcome was hospital admission rate within 4 h. A total of 906 ED visits by children with moderate or severe acute asthma were evaluated. Seventy-five cases out of 458 (16.4%) in the budesonide group vs 82 of 448 (18.3%) in the placebo group were admitted (OR, 0.84; 95% CI, 0.58-1.23; P=.38). However, among cases with high baseline clinical score (≥13), significantly fewer children were admitted in the budesonide group (27 of 76 [35.5%]) than in the placebo group (39 of 73 [53.4%]; OR, 0.42; 95% CI, 0.19-0.94; P=.03). The addition of budesonide nebulization did not decrease the admission rate of children with acute asthma overall. However, it may decrease the admission rate of children with severe acute asthma. ClinicalTrials.gov; No.: NCT01524198; URL: www.clinicaltrials.gov

DI-097 Budesonide suspension for Eosinophilic Esophagitis

BackgroundEosinophilic esophagitis (EoE) is a clinicopathological disease characterised by oesophageal eosinophilia and gastrointestinal symptoms. It is caused by immunologic reactions to ingested and inhaled allergens. The diagnosis is considered if...

DI-038 Efficay and safety evaluation of Anakinra off-label use for Schintzler syndrome. A case report

BackgroundEosinophilic esophagitis (EoE) is a clinicopathological disease characterised by oesophageal eosinophilia and gastrointestinal symptoms. It is caused by immunologic reactions to ingested and inhaled allergens. The diagnosis is considered if...

Effect of nebulized budesonide in preventing postextubation complications in critically patients: A prospective, randomized, double-blind, placebo-controlled study

Background:The efficacy of steroid administration in the prevention of postextubation complications in critical care remains controversial. The purpose of this study was to determine whether administration of nebulized budesonide in critically ill patients reduces the occurrence of postextubation airway complications.Materials and Methods:This was a prospective, randomized, double-blind, placebo-controlled study. We prospectively followed up 70 adult patients in the intensive care unit who were intubated for more than 48 h. Patients received either nebulized budesonide (1 mg every 12 h; n = 35) or placebo (normal saline; n = 35) until 48 h after extubation. Then, the postextubation complications were assessed and recorded within 48 h of extubation.Results:The incidence of respiratory distress was lower in budesonide group (8.6% vs. 31.4%, P = 0.017). Reintubation with mechanical support was necessary in 8.6% (3.35) of patients in the budesonide group and 31.4% (11.35) of patients in the placebo group (P = 0.017).Conclusion:Nebulized budesonide after extubation is effective in reducing the incidence of reintubation and respiratory distress in adult patients.

Case 1: A premature infant with apneic spells

A female infant was born at 25 weeks, three days’ gestational age with a birth weight of 820 g. The issues encountered during her stay at a tertiary-level neonatal intensive care unit (NICU) included prematurity, respiratory distress syndrome, chronic lung disease (CLD), patent ductus arteriosis, a single course of treatment with indomethacin, hypoglycemia, two red blood cell infusions, grade 1 intraventricular hemorrhage, mild periventricular leukomalacia and retinopathy of prematurity. Her respiratory history included three doses of surfactant, high-frequency oscillation and eventual extubation on day 7 of life to nasal prong continuous positive airway pressure. No systemic steroids were administered for extubation. On day 9 of life, the patient was started on inhaled nebulized budesonide 500 μg twice daily. She was initially on high-flow oxygen, and was then maintained on low-flow oxygen and, eventually, room air. On day 59 of life, the patient was transferred from the tertiary-level NICU to a secondary-level NICU (level 2C). Budesonide was weaned over a seven-day period. During this period, she became unwell, with increasing signs of respiratory distress, apneic spells and a urine sample obtained by catheterization positive for Enterococcus species and Escherichia coli. Urosepsis was suspected and treatment with intravenous fluids and intravenous antibiotics was commenced. The infant received 25 mL/min supplementary oxygen for 48 h and was then transitioned to room air. Fluid boluses for hypotension were not required, and the infant eventually recovered from the acute episode. Blood and cerebrospinal fluid cultures were negative for bacterial growth. A laboratory test was conducted due to clinical suspicion and revealed the underlying diagnosis.

Therapeutic effect of inhaled budesonide (Pulmicort® Turbuhaler) on the inflammatory response to one‐lung ventilation

This prospective, double-blind trial was designed to evaluate the effect of inhaled budesonide on lung function and the inflammatory response to one-lung ventilation. One hundred patients scheduled for lobectomy were allocated randomly to pre-operative nebulised budesonide or saline. Bronchoalveolar lavage fluid samples were collected from either the collapsed or the ventilated lung both before one-lung ventilation and 30 min after re-expansion of the lung. The concentrations of serum and bronchoalveolar lavage fluid cytokines were determined. Budesonide treatment, compared with saline, reduced both peak (mean (SD) 3.7 (0.4) vs 2.5 (0.2) kPa) and plateau (mean (SD) 3.1 (0.2) vs 2.2 (0.1) kPa, respectively, p < 0.001 for both) ventilatory pressures. Thirty minutes after re-expansion, lung compliance increased in the budesonide group compared with saline (57.5 (4.1) vs 40.1 (3.5) ml.cmH(2) O(-1), respectively p < 0.001). Budesonide also reduced the concentrations of tumour necrosis factor-α, interleukin-1β, interleukin-6 and interleukin-8 in bronchoalveolar lavage fluid, but increased interleukin-10 30 min after re-expansion (p < 0.05 for all measures). Pre-operative nebulisation of budesonide may be effective in improving ventilatory mechanics and reducing the inflammatory response to one-lung ventilation during thoracic surgery.

A Case of Esophageal Candidiasis in an Adolescent Who Had Frequently Received Budesonide Nebulizing Therapy

Corticosteroid (budesonide) nebulizer therapy is commonly performed. Its side effects have been considered as being safe or ignorable. The authors present a case of esophageal candidiasis in a healthy female adolescent who was treated with budesonide nebulizer therapy a few times for a cough during the previous winter season. This child presented with dysphagia and epigastric pain for 1 month. Esophageal endoscopy showed a whitish creamy pseudomembrane and erosions on the esophageal mucosa. Pathologic findings showed numerous candidal hyphae. She did not show any evidence of immunodeficiency, clinically and historically. The esophageal lesion did not resolve naturally. The esophageal lesion completely improved with the antifungal therapy for 2 weeks; the symptoms disappeared, and the patient returned to normal health. It is important that frequent esophageal exposure to topical corticosteroids application can cause unexpected side effects.

Acute Upper Airway Obstruction

Upper airway obstruction is defined as blockage of any portion of the airway above the thoracic inlet. Stridor, suprasternal retractions, and change of voice are the sentinel signs of upper airway obstruction. Most of the common causes among children presenting to emergency department are of acute infectious etiology. Among these, croup is the commonest while diphteria remains the most serious life-threatening cause. Recent reports indicate that bacterial tracheitis has become increasingly common. In ER evaluation the key clinical data in determining the cause and the site of obstruction are the onset, presence of fever, character of the stridor, retractions, the voice and the ability to handle secretions. After assessment of the severity of respiratory distress and resuscitative or supportive therapy including oxygen and emergent airway, specific treatment is directed at underlying etiology. All patients with audible stridor require early endotracheal intubation/tracheostomy. In croup the mainstay of treatment are cold humidified oxygen, budesonide nebulization ( in mild cases), Dexamethasone 0.6 mg/kg iv or im (in moderate and severe cases), and Adrenaline 5 ml 1:1000 (5 mg) solution as nebulization ( in severe cases). In diphtheria, early tracheostomy, anti-diphtheric serum and injectable penicillin are critical. Bacterial Tracheitis and Retropharyngeal abscess need early administration of injectable Cloxacillin, Amikacin and Clindamycin. ENT consultation should be obtained for early surgical drainage of retropharyngeal abscess. Angioneurotic edema is treated with subcutaneous adrenaline (1:1000, 0.01 ml/kg); hydrocortisone 10 mg/kg IV and antihistamines. Patients with severe obstruction and those with endotracheal tube/ trachesotomy should be transferred to PICU.

Effect of budesonide nebulization in treatment of patients with chronic obstructive pulmonary disease and ventilator-associated pneumonia

Objective To explore the effect of budesonide nebulization in treatment of patients with chronic obstructive pulmonary disease and ventilator-associated pneumonia. Methods A total of 49 cases with COPD and VAP was randomly divided into two groups:the control group consisted of 24 patients received salbutamol nebulization on the routine treatment.The observe group consisted of 25 patients received budesonide plus salbutamol bulization on the routine treatment.Variables such as TNF-αt and IL-8 in the bronchial alveolar lavage fluid(BALF),and efficacy of pneumonia and clinical healing rate were observed. Results The levels of TNF-α and IL-8 in BALF of the observe group were significantly lower than those in the control group after 72h(all P＜0.05).The days of symptoms,signs and bedside chest X-ray improved,off-machine time,extubation time and the days of inpatient were statistically shorter in observe group compared with the control group(all P＜0.05).But the clinical cure rate of the observe group was no significant improvement. Conclusion The nebulization of budesonide could suppress the local pulmonary inflammation and reduce the time of machine ventilation and improve prognosis in COPD patients with VAP. Key words: Budesonide; Chronic obstructive pulmonary disease; Ventilator-associated pneumonia; Mechanical ventilation

Development and Validation of a Stability-Indicating High-Performance Liquid Chromatography Method for the Simultaneous Determination of Albuterol, Budesonide, and Ipratropium Bromide in Compounded Nebulizer Solutions

In recent years, there has been a large increase in the use of pharmaceutical compounding to prepare medications that are not commercially available. The treatment of asthma typically includes the use of albuterol (ALB), ipratropium bromide (IPB), and/or budesonide (BUD) nebulizer solutions. There is currently no commercially available nebulizer solution containing all three of these compounds, and patients must rely on often-unregulated compounding. There is a distinct need for methodologies that can be used to analyze compounded formulations to ensure patient safety. We report an HPLC-UV method to separate and quantitate ALB, IPB, and BUD in nebulizer solutions. The method used a gradient elution to achieve separation via an RP C18 column. The method was validated, showed good selectivity, and was linear over several orders of magnitude. The method was applied to the analysis of nebulizer solutions and determination of their storage stability. Significant ALB-dependent degradation occurred within 5 h in solutions formulated with the free base of ALB, while those containing the sulfate salt of ALB produced no degradation. Alkali solutions can cause base-catalyzed hydrolysis of IPB and degradation of BUD. Compounded formulations containing ALB need to include an acid to control pH and prevent degradation.

A Novel Submicron Formulation of Nebulized Budesonide Delivered by a Vibrating Mesh Nebulizer Significantly Improves Delivery Efficiency at One-Fifth of the Nominal Dose of both Pulmicort Respules® and a Generic Budesonide Suspensions Delivered via a Jet Nebulizer - A Potentially Important Advancement in Pediatric Asthma

RATIONALE: Innovative aerosol generators can improve nebulization efficiency of aqueous suspensions by eliminating large residual volumes and concentrating effects associated with jet nebulizers. A novel submicron budesonide dispersion (sBUD) has been developed for use with these innovative aerosol generators, which are not approved for use with marketed aqueous suspensions used to treat of pediatric asthma.

A Novel Submicron Formulation of Nebulized Budesonide Significantly Decreases the Nebulization Time from a Variety of Commercially Available Jet Nebulizers

A Novel Submicron Formulation of Nebulized Budesonide Significantly Decreases the Nebulization Time from a Variety of Commercially Available Jet Nebulizers

A Novel Submicron Formulation of Nebulized Budesonide Significantly Improves the Fine Particle Fraction of Drug Available for Inhalation From Various Jet Nebulizers Compared to a Marketed Budesonide Suspension

A Novel Submicron Formulation of Nebulized Budesonide Significantly Improves the Fine Particle Fraction of Drug Available for Inhalation From Various Jet Nebulizers Compared to a Marketed Budesonide Suspension

Croup Management in Australia and New Zealand

Comparison of clinical practice guideline (CPG) recommendations and reported physician management of croup at PREDICT (Paediatric Research in Emergency Departments International Collaborative) sites as baseline for planned randomized controlled trials. Review of CPGs for croup from PREDICT sites and survey of specialist pediatric emergency physicians regarding croup management. PREDICT sites included 8 tertiary pediatric hospitals and 3 large mixed emergency departments in Australia and New Zealand. Nine of the 11 sites had a CPG for croup. Response rate was 94% (78/83). Adrenaline was recommended for moderate croup (3%), severe croup (52%), and life-threatening croup by (100%). Steroid therapy was recommended for mild croup (45%), for moderate croup (97%), for severe croup (97%), and for life-threatening croup (96%). Steroid choice was oral dexamethasone (60%) and oral prednisolone (38%). In severe croup, 77% used intravenous/intramuscular dexamethasone, 10% used intravenous/intramuscular methylprednisolone, and 8% used nebulized budesonide. Commonest dosage regimens were 0.15 mg/kg dexamethasone or 1 mg/kg prednisolone. A standard volume dosage regimen for nebulized adrenaline was used by 54%, whereas 39% used a weight-based formula. Clinical practice guidelines recommended 5 mg (11%) or 10 mg (33%) for standard volume dosing, and all CPGs using weight-based dosing recommend 0.5 mg/kg with maximum doses ranging from 5 to 15 mg. Croup management at PREDICT emergency departments is similar, based on oral steroids and nebulized adrenaline. The steroid and adrenaline regimens used by respondents and their CPGs were not consistent. This reflects limitations of available evidence for management of this common disease, highlighting the need for definitive trials, particularly in the management of mild croup.

Risk of recurrent emergency department visits or hospitalizations in children with asthma receiving nebulized budesonide inhalation suspension compared with other asthma medications

ABSTRACTObjective: To examine whether nebulized budesonide inhalation suspension treatment reduces asthma-related emergency department visit/hospitalization recurrence risk in children compared with other asthma medications, particularly non-nebulized inhaled corticosteroids.Research design and methods: Longitudinal, retro­spective claims analysis of data from a managed care organization database in the United States (July 1, 2000–June 30, 2002). Participants were children aged ≤ 8 years with an asthma diagnosis and asthma-related emergency department visit or hospitalization (index event). Asthma medication use, evaluated by asthma-related prescriptions ≤ 30 days after the index event, determined treatment groups.Main outcome measure: Emergency department visit/hospitalization recurrence risk from post-index day 31–180 across treatment groups.Results: Of 10 176 patients with an index event, 13% experienced a post-index recurrence. For patients receiving asthma prescriptions ≤ 30 days after the index event, those receiving budesonide inhalation suspension showed a significant reduction in emergency department visit/hospitalization recurrence risk compared with those not prescribed this treatment (adjusted hazard ratio, 0.71; 95% confidence interval, 0.57–0.89). For patients receiving asthma controller medication in the post-index period, those receiving budesonide inhalation suspension had a significantly lower recurrence risk than patients receiving prescriptions for other controller medications (hazard ratio, 0.71; 95% confidence interval, 0.52–0.97). Recurrence risk was significantly reduced (53%) in patients receiving budesonide inhalation suspension prescriptions compared with non-nebulized inhaled corticosteroid prescriptions (hazard ratio, 0.47; 95% confidence interval, 0.28–0.78).Conclusion: For children aged ≤ 8 years, budesonide inhalation suspension treatment after an asthma-related emergency department visit/hospitalization was associated with a significantly reduced risk of recurrence compared with other asthma medications and with non-nebulized inhaled corticosteroids. Because this was an observational study, results should be interpreted cautiously. However, this study allowed evaluation of treatment in real-world practice settings not often included in clinical trials.

The role of nebulised budesonide in the treatment of exacerbations of COPD

The present study was designed to evaluate the hypothesis that nebulised budesonide (NB) might be an alternative to systemic corticosteroids (SC) in the treatment of patients with exacerbations of chronic obstructive pulmonary disease (ECOPD). Patients hospitalised with ECOPD (n = 159) were randomised into three groups. Group 1 received only standard bronchodilator treatment (SBDT), group 2 received SC (40 mg prednisolone) plus SBDT, and group 3 received NB (1,500 microg q.i.d.) plus SBDT. Improvement during 10-day hospitalisation was compared with exacerbation and rehospitalisation rates after discharge. While mean+/-sd age was 64.1+/-8.9 yrs (female/male = 0.1), mean forced expiratory volume in one second (FEV(1)) at admission was found to be 37.2+/-12.2% predicted. Arterial blood gases and spirograms recovered faster in groups 2 and 3. While improvements in arterial oxygen tension (P(a,O(2))) and forced vital capacity (FVC) in group 2, and improvements in P(a,O(2)), FVC and FEV(1) in group 3, became significant at 24-h control, the first significant improvement in group 1 appeared in arterial oxygen saturation at 72-h control. The mean improvement of P(a,O(2)) after 10 days was 1.20 and 1.06 kPa (9 and 8 mmHg) higher in group 2 and 3, respectively, than in group 1. Blood glucose exhibited an upward trend only in group 2. The study demonstrates that nebulised budesonide may be an effective and safe alternative to systemic corticosteroids in the treatment of exacerbations of chronic obstructive pulmonary disease.

Effectiveness of budesonide nebulising suspension compared to disodium cromoglycate in early childhood asthma

ABSTRACTObjective: The optimal treatment for early childhood asthma remains controversial. Budesonide (BUD) has shown superiority over placebo in infants, and over disodium cromoglycate (DSCG) in children aged > 2 years. The aim of this double-blind, randomised, parallel-group study was to compare the effectiveness of nebulised BUD and DSCG in asthmatic children aged < 36 months.Research design and methods: 82 infants (mean age 18.0 months [range, 11.6–31.2 months]) with suspected asthma (three exacerbations of dyspnoea and wheezing during the past 12 months, with one or more exacerbations in the past 3 months) were treated for 3 months with nebulised BUD (Pulmicort Respules) 0.5 mg/2 mL bid or DSCG 20 mg/2 mL tid. Follow-up was at 6 months.* Pulmicort and Respules are registered trade names of the AstraZeneca group of companiesMain outcome measures and results: Patients treated with BUD had a lower exacerbation rate than DSCG-treated patients after 3 months of treatment (5.4% vs. 31.7%; p = 0.003) and towards the end of follow-up (30% vs. 49%; p = 0.062). During treatment, days without cough were 80% and 65% for BUD and DSCG, respectively ( p = 0.014), and nights without cough were 89% and 78%, respectively ( p = 0.016). Side-effects were mild and of similar frequency in both groups.Conclusions: Inhaled nebulised BUD was well tolerated and more effective than nebulised DSCG in reducing the incidence of asthma exacerbations and days with symptoms. These beneficial effects of BUD were maintained throughout the 6‐month follow-up.

Hypoglycemia due to adrenal suppression secondary to high-dose nebulized corticosteroid.

High-dose inhaled corticosteroids, greater than 400 mcg per day of beclomethasone dipropionate or equivalent, can cause adrenal insufficiency, but a hypoglycemic crisis has not been reported with the use of nebulized corticosteroids. We describe a 21-month-old asthmatic boy who had a hypoglycemic seizure during a proven acute adrenal crisis secondary to high-dose nebulized budesonide treatment.

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...