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Journal of Pediatric Gastroenterology... Aug 2022The pharmacokinetic (PK) profile of budesonide oral suspension (BOS) was evaluated during a phase 2, randomized, double-blind, placebo-controlled, dose-ranging study in... (Randomized Controlled Trial)
Randomized Controlled Trial
The pharmacokinetic (PK) profile of budesonide oral suspension (BOS) was evaluated during a phase 2, randomized, double-blind, placebo-controlled, dose-ranging study in pediatric patients with eosinophilic esophagitis (EoE) (MPI 101-01/NCT00762073). Non-compartmental methods were used to calculate PK parameters in 37 patients after receiving morning doses of BOS, with volume and dose adjusted for age (low dose: 0.35 or 0.5 mg; high dose: 1.4 or 2.0 mg [2-9 or 10-18 years old, respectively]). Relationships between apparent oral clearance and volume of distribution, and bodyweight and body mass index were also evaluated. Budesonide systemic exposure increased with BOS dose. After oral administration, time to maximum plasma budesonide concentration occurred ~1 hour post dose and the half-life of budesonide was 3.3-3.5 hours. PK parameters were similar between age groups for low- and high-dose BOS, indicating that volume and dose adjustments for age were appropriate for pediatric patients with EoE. BOS was well tolerated.
Topics: Administration, Oral; Adolescent; Budesonide; Child; Double-Blind Method; Eosinophilic Esophagitis; Glucocorticoids; Humans; Suspensions; Treatment Outcome
PubMed: 35666852
DOI: 10.1097/MPG.0000000000003482 -
World Journal of Gastroenterology Jun 2013The treatment of microscopic colitis is mainly based on the use of budesonide, the only drug found effective in controlled clinical trials. After an initial course at a...
The treatment of microscopic colitis is mainly based on the use of budesonide, the only drug found effective in controlled clinical trials. After an initial course at a dose of 9 mg daily, however, most patients relapse when the drug is discontinued, hence a maintenance therapy at doses of 6 mg daily or lower is necessary. In order to avoid steroid dependence and drug toxicity different pharmacological agents should be considered as an alternative to indefinite long-term budesonide treatment. Evidence-based guidelines are currently lacking due to the lack of conclusive data concerning the use of either immunosuppressive or anti-tumor necrosis factor agents. For the time being in clinical practice the skilled physician should therefore tailor long term management of microscopic colitis on the single patient.
Topics: Anti-Inflammatory Agents; Budesonide; Colitis, Microscopic; Drug Administration Schedule; Glucocorticoids; Humans; Immunosuppressive Agents; Recurrence; Remission Induction; Risk Factors; Time Factors; Treatment Outcome
PubMed: 23801853
DOI: 10.3748/wjg.v19.i23.3531 -
Liver Transplantation : Official... Nov 2020Despite adverse effects like hyperglycemia, new-onset diabetes after transplant (NODAT), and infectious complications, corticosteroid use remains an important part of...
Despite adverse effects like hyperglycemia, new-onset diabetes after transplant (NODAT), and infectious complications, corticosteroid use remains an important part of liver transplantation (LT) immune suppression. Budesonide, a synthetic corticosteroid, undergoes extensive first-pass hepatic metabolism with only 10% systemic bioavailability, providing an opportunity for an improved toxicity-therapeutic ratio. Although effective in the treatment of autoimmune hepatitis, the effects of budesonide for LT immune suppression are unknown. We conducted a single-center phase 2a trial to study the safety and efficacy of budesonide immunosuppressive therapy. From July 2017 to November 2018, 20 patients undergoing a first LT received budesonide tapering doses (from 9 to 3 mg) for 12 weeks. Patients were compared with matched control patients who received prednisone from the same time period. Additionally, both groups received calcineurin inhibitors and mycophenolate mofetil. Outcome measures at week 24 included rates of biopsy-proven acute cellular rejection (ACR), NODAT (hemoglobin A1c >6.4%), and infectious complications. In the budesonide arm, 1 patient developed ACR at week 5 and was removed from the study. Another patient stopped the study drug at week 8 due to persistent nausea. Rates of ACR were similar between the budesonide and control groups (5% versus 5%, P = 1.00). Three patients in the control group developed NODAT versus none in the budesonide group (15% versus 0%; P = 0.23). There were 6 infections in the control group compared with none in the budesonide group (30% versus 0; P = 0.02). These pilot data suggest that budesonide has the potential to be a safe and effective alternative to prednisone for LT immune suppression while reducing steroid-induced infections and NODAT. Randomized controlled trials are required to validate these findings.
Topics: Budesonide; Calcineurin Inhibitors; Graft Rejection; Humans; Immunosuppression Therapy; Liver Transplantation
PubMed: 32602616
DOI: 10.1002/lt.25837 -
International Journal of Chronic... 2006The budesonide-formoterol dry powder inhaler (Symbicort Turbuhaler 160/ 4.5-640/18 microg/day) contains the long-acting beta2-adrenoreceptor agonist formoterol and the... (Review)
Review
The budesonide-formoterol dry powder inhaler (Symbicort Turbuhaler 160/ 4.5-640/18 microg/day) contains the long-acting beta2-adrenoreceptor agonist formoterol and the inhaled corticosteroid budesonide. Two large, 12-month trials examined the effect of budesonide-formoterol 160/4.5 microg twice daily in COPD patients who met these criteria. The studies were identical, except one in which the patients had received oral prednisolone 30 mg/ day and had inhaled formoterol 4.5 microg twice daily for 2 weeks before randomization. In terms of the FEV1, budesonide-formoterol produced an effect greater than that of both budesonide alone and formoterol alone reported in previous studies. The combination was generally more effective than either of the components in terms of peak expiratory flow, symptoms, and exacerbations. These advantages of the combination over those of either budesonide alone or formoterol alone were quite consistent. Improving lung function and decreasing symptoms significantly, budesonide-formoterol combination therapy provides significant clinical improvements in COPD, despite the limited reversibility of impaired lung function in the disease.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Anti-Asthmatic Agents; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Drug Combinations; Ethanolamines; Humans; Powders; Pulmonary Disease, Chronic Obstructive; Quality of Life; Treatment Outcome
PubMed: 18046888
DOI: 10.2147/copd.2006.1.2.115 -
American Journal of Physiology. Lung... May 2019Mechanical ventilation with normal tidal volumes (V) causes lung and systemic inflammation in preterm sheep. Mechanical ventilation is associated with bronchopulmonary...
Mechanical ventilation with normal tidal volumes (V) causes lung and systemic inflammation in preterm sheep. Mechanical ventilation is associated with bronchopulmonary dysplasia (BPD) in preterm infants, and the addition of budesonide to surfactant decreases BPD in clinical trials. Budesonide with surfactant will decrease the lung injury from mechanical ventilation for 24 h in preterm sheep. Lambs at 126 ± 1 day gestational age were delivered and randomized to either: ) surfactant (200 mg/kg) or ) surfactant mixed with budesonide (0.25 mg/kg) before mechanical ventilation with V of 7-8 ml/kg for 2, 6, or 24 h ( = 6 or 7/group). Lung physiology and budesonide levels in the plasma and the lung were measured. Lung tissue, bronchoalveolar lavage fluid (BALF), liver, and brain tissues were evaluated for indicators of injury. High initial budesonide plasma levels of 170 ng/ml decreased to 3 ng/ml at 24 h. Lung tissue budesonide levels were less than 1% of initial dose by 24 h. Although physiological variables were generally similar, budesonide-exposed lambs required lower mean airway pressures, had higher hyperoxia responses, and had more stable blood pressures. Budesonide decreased proinflammatory mRNA in the lung, liver, and brain. Budesonide also decreased total protein and proinflammatory cytokines in BALF, and decreased inducible nitric oxide synthase activation at 24 h. In ventilated preterm lambs, most of the budesonide left the lung within 24 h. The addition of budesonide to surfactant improved physiology, decreased markers of lung injury, and decreased systemic responses in liver and brain.
Topics: Animals; Animals, Newborn; Brain; Budesonide; Inflammation; Liver; Lung; Pneumonia; Pulmonary Surfactants; Respiration, Artificial; Sheep
PubMed: 30838863
DOI: 10.1152/ajplung.00477.2018 -
Digestive Diseases and Sciences Jun 2021Non-responsive celiac disease (NRCD) has many aetiologies, including gluten exposure. Budesonide may be used for refractory celiac disease (RCD) and celiac crisis. (Observational Study)
Observational Study
BACKGROUND
Non-responsive celiac disease (NRCD) has many aetiologies, including gluten exposure. Budesonide may be used for refractory celiac disease (RCD) and celiac crisis.
AIMS
We reviewed the effectiveness of budesonide to induce clinical and histologic response in NRCD with villous atrophy (VA).
METHODS
Case series of adult cases with NRCD and VA prescribed budesonide at two celiac centers. Clinical variables and mucosal recovery (i.e., normal villous architecture within 1 year of treatment) were evaluated.
RESULTS
Forty-two cases [77% female, median age 45.0 (IQR 28.3-60.0) years] were included. Most common symptoms were diarrhea (64%) and abdominal pain (62%). Budesonide was initiated at 9 mg (83%) for a median duration of 16.0 weeks (IQR 6.8-25.0 weeks). In total, 57% exhibited a clinical response, positively associated with diarrhea (adjusted OR 6.08 95% CI 1.04-35.47) and negatively with fatigue (adjusted OR 0.18 95% CI 0.03-0.98). Clinical response was higher among those with dietitian counseling prior to budesonide (n = 29, 70 vs. 23%, p < 0.01). Mucosal recovery was observed in 11/24 with follow-up duodenal biopsies. There was no association between clinical response and mucosal recovery, and 79% of clinical responders had a symptomatic relapse. RCD (48%) and chronic gluten exposure (24%) were the main suspected aetiologies of NRCD. Most individuals without a clinical response subsequently received an IBS-related diagnosis.
CONCLUSIONS
Budesonide may be effective to induce clinical response in NRCD presenting with diarrhea and VA, but clinical recurrence and lack of mucosal recovery are frequent after tapering. Other diagnoses, including coexisting IBS, may be considered in non-responders to budesonide therapy.
Topics: Adult; Anti-Inflammatory Agents; Budesonide; Celiac Disease; Cohort Studies; Diet, Gluten-Free; Disease Management; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Intestinal Mucosa; Male; Middle Aged; Retrospective Studies
PubMed: 32654085
DOI: 10.1007/s10620-020-06454-5 -
BMC Pediatrics Apr 2024Respiratory distress syndrome (RDS) is one of the most important and common disorders among premature infants. (Randomized Controlled Trial)
Randomized Controlled Trial
The impact of combined administration of surfactant and intratracheal budesonide compared to surfactant alone on bronchopulmonary dysplasia (BPD) and mortality rate in preterm infants with respiratory distress syndrome: a single-blind randomized clinical trial.
BACKGROUND
Respiratory distress syndrome (RDS) is one of the most important and common disorders among premature infants.
OBJECTIVE
This study aimed to compare the effect of the combination of surfactant and budesonide with surfactant alone on Bronchopulmonary dysplasia (BPD) and mortality rate among premature infants with RDS.
METHOD
An outcome assessor-blind randomized clinical trial was conducted on 134 premature infants with RDS who were born in Ayatollah Mousavi Hospital, Zanjan, Iran in 2021. The covariate adaptive randomization method was utilized to allocate participants into two groups (surfactant alone and a combination of surfactant and budesonide). The primary outcomes were BPD and Mortality rate from admission to hospital discharge. The data in this study were analyzed using SPSS software version 18.
RESULTS
Overall the comparison of mortality rate and BPD between the two groups did not show a significant difference(p > 0.05). The subgroup results showed that administering surfactant with budesonide to infants under 30 weeks of age significantly reduced the number of deaths compared to using surfactant alone (5 vs. 17). Similar positive effects were observed for the occurrence of Pulmonary Hemorrhage, the need for a second dose of surfactant, oxygen index, mean blood pressure and mean arterial pressure (MAP) in infants under 34 weeks of age compared to more than 34 weeks (p < 0.05).
CONCLUSION
These findings suggest that the combination therapy of surfactant and budesonide may be beneficial, particularly in preterm infants with less than 34 weeks gestational age and 1500 birth weight. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and assess long-term outcomes.
TRIAL REGISTRATION
The study was registered at the Iranian Registry of Clinical Trials website under the code IRCT20201222049802N1. https://en.irct.ir/user/trial/48117/view .
REGISTRATION DATE
28/02/2021.
PUBLIC REPOSITORY
DATA SET: This research data set link is displayed on the Zanjan-Iran Medical Sciences website: https://repository.zums.ac.ir/cgi/users/login? target=https%3 A%2 F/repository.zums.ac.ir/id/eprint .
Topics: Infant; Infant, Newborn; Humans; Infant, Premature; Budesonide; Surface-Active Agents; Bronchopulmonary Dysplasia; Iran; Single-Blind Method; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Pulmonary Surfactants; Lipoproteins
PubMed: 38643076
DOI: 10.1186/s12887-024-04736-9 -
United European Gastroenterology Journal Sep 2021Incomplete microscopic colitis (MCi) is a subtype of microscopic colitis (MC). Budesonide is recommended as a first-line treatment for MC. However, randomised trials on... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND AND AIMS
Incomplete microscopic colitis (MCi) is a subtype of microscopic colitis (MC). Budesonide is recommended as a first-line treatment for MC. However, randomised trials on efficacy of treatment in MCi are missing. We therefore performed a randomised, placebo-controlled trial to evaluate budesonide as induction therapy for MCi.
METHODS
Patients with active MCi were randomly assigned to either budesonide 9 mg once daily or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as a mean of <3 stools/day and a mean of <1 watery stool/day in the 7 days before week 8.
RESULTS
Due to insufficient patient recruitment, the trial was discontinued prematurely. The intention-to-treat analysis included 44 patients (21 budesonide and 23 placebo). The primary endpoint of clinical remission at week 8 was obtained by 71.4% on budesonide and 43.5% on placebo (p = 0.0582). All clinical secondary endpoints were in favour of budesonide. Budesonide decreased the number of soft or watery stools (16.3 vs. 7.7, p = 0.0186) and improved health-related quality of life for all four dimensions of the short health scale. Adverse events with a suspected relation to study drug were reported in one patient in the budesonide group and two patients in the placebo group. Neither serious nor severe adverse events occurred during the double-blind phase.
CONCLUSIONS
Budesonide decreased the frequency of soft or watery stools and improved the patients' quality of life significantly in MCi, but the primary endpoint was not met due to the low sample size (type 2 error). Budesonide was safe and well tolerated during the 8-weeks treatment course.
Topics: Anti-Inflammatory Agents; Budesonide; Colitis, Microscopic; Double-Blind Method; Drug Administration Schedule; Female; Humans; Induction Chemotherapy; Kaplan-Meier Estimate; Male; Middle Aged; Placebos; Quality of Life
PubMed: 34414678
DOI: 10.1002/ueg2.12131 -
Journal of Infection and Public Health Jan 2022
Topics: Budesonide; COVID-19; Glucocorticoids; Humans; SARS-CoV-2
PubMed: 34802976
DOI: 10.1016/j.jiph.2021.11.003 -
Viruses Jul 2021Treatment options for COVID-19, a disease caused by Coronavirus 2 (SARS-CoV-2) infection, are currently severely limited. Therefore, antiviral drugs...
Treatment options for COVID-19, a disease caused by Coronavirus 2 (SARS-CoV-2) infection, are currently severely limited. Therefore, antiviral drugs that efficiently reduce SARS-CoV-2 replication or alleviate COVID-19 symptoms are urgently needed. Inhaled glucocorticoids are currently being discussed in the context of treatment for COVID-19, partly based on a previous study that reported reduced recovery times in cases of mild COVID-19 after inhalative administration of the glucocorticoid budesonide. Given various reports that describe the potential antiviral activity of glucocorticoids against respiratory viruses, we aimed to analyze a potential antiviral activity of budesonide against SARS-CoV-2 and circulating variants of concern (VOC) B.1.1.7 (alpha) and B.1.351 (beta). We demonstrate a dose-dependent inhibition of SARS-CoV-2 that was comparable between all viral variants tested while cell viability remains unaffected. Our results are encouraging as they could indicate a multimodal mode of action of budesonide against SARS-CoV-2 and COVID-19, which could contribute to an improved clinical performance.
Topics: Adrenal Cortex Hormones; Animals; Antiviral Agents; Budesonide; COVID-19; Chlorocebus aethiops; Glucocorticoids; Humans; SARS-CoV-2; Vero Cells; Virus Replication; COVID-19 Drug Treatment
PubMed: 34372616
DOI: 10.3390/v13071411