Safety Of Budesonide Research Articles

An open-label study evaluating the safety and efficacy of budesonide in patients with IgA nephropathy at high risk of progression

We sought to evaluate the efficacy and safety of budesonide (Budenofalk) in the treatment of patients with IgA Nephropathy. We conducted a prospective, interventional, open-label, single-arm, non-randomized study that enrolled 32 patients with IgAN at high risk of progression (BUDIGAN study, ISRCTN47722295, date of registration 14/02/2020). Patients were treated with Budesonide at a dose of 9 mg/day for 12 months, subsequently tapered to 3 mg/day for another 12 months. The primary endpoints were change of eGFR and proteinuria at 12, 24 and 36 months. The study cohort had a mean eGFR and 24-h proteinuria of 59 ± 24 ml/min/1.73m2 and 1.89 ± 1.5 g/day, respectively. Treatment with budesonide determined a reduction in proteinuria at 12-, 24- and 36-months by -32.9% (95% CI − 53.6 to − 12.2), − 49.7% (95% CI − 70.1 to − 29.4) and − 68.1% (95% CI − 80.6 to − 55.7). Budesonide determined an eGFR preservation corresponding to a 12-, 24- and 36-months change of + 7.68% (95% CI − 4.7 to 20.1), + 7.42% (95% CI − 7.23 to 22.1) and + 4.74% (95%CI − 13.5 to 23), respectively. The overall eGFR change/year was + 0.83 ml/min/y (95% CI − 0.54 to 4.46). Budesonide was well-tolerated, and treatment emergent adverse events were mostly mild in severity and reversible. Budesonide was effective in the treatment of patients with IgAN at high-risk of progression in terms of reducing proteinuria and preserving renal function over 36 months of therapy.

Long-term Effects of Intratracheal Budesonide and Surfactant for the Prevention of Bronchopulmonary Dysplasia: A Narrative Review.

This study aimed to compare the safety and efficacy of intratracheal administration of budesonide and surfactant with surfactant alone for bronchopulmonary dysplasia (BPD) prevention in premature infants with respiratory distress syndrome. A literature search was performed in MEDLINE, Embase, Cochrane, ClinicalTrials.gov, and gray literature. Assessment of quality was conducted using CASP tool, ROBIS tool, and GRADE framework. A systematic review and meta-analysis and three observational studies were identified. Budesonide was associated with reduced incidence and severity of BPD, reduced mortality, patent ductus arteriosus, need for additional surfactant doses, hypotension, duration of invasive ventilation, hospital stays, salbutamol prescriptions, and hospitalizations in the first 2 years of life. The safety of budesonide on neurodevelopmental outcomes at 2 to 3 years of corrected age was reported. Budesonide might be associated with a reduction in BPD incidence and severity, without evidence of impaired neurodevelopment at 2 to 3 years of age. According to the GRADE framework, the level of evidence is low due to significant heterogeneity of studies and other bias. · BPD prevention is urgently needed.. · Intratracheal budesonide and surfactant for neonatal RDS could reduce BPD.. · The grade of evidence for this intervention is low due to study heterogeneity and other bias..

Budesonide/formoterol versus salmeterol/fluticasonefor asthmain children: an effectiveness and safety analysis.

Background: The efficacy of budesonide+formoterol therapy compared with high-dose salmeterol+fluticasone therapy plus short-acting β-agonist (SABA) has not beenevaluated specifically in children. Objectives: To evaluate the efficacy and safety of budesonide+formoterolcombination therapy two times a day plus as needed compared with salmeterol+fluticasone two times a dayplusSABA (as needed) in children in China. Methods: This prospective cohort study included 164 children with persistent asthma (aged 12-17years) who had experienced a minimum of one asthma exacerbation in12months prior to the study. The primary outcome was the time to the first severe exacerbation. Results: Eighty-twochildren were assigned to each of twogroups. The exacerbation rate per 100 patients per year was notfound to besignificantly different. The number of patients with hospitalization/emergency room therapy was lower inbudesonide+formoterol group, but the risk difference was not statistically significant. Asthma control measures showed comparable effects. Bothtreatments were well-tolerated. Conclusion: No significant differences were observed in the outcome measures between the groups. Budesonide+formoterol therapy is a favorable approach in terms of a low load of ICS, steroid exposure, need for multiple inhalers and cost.

Inhaled Budesonide vis-à-vis Inhaled Mometasone in Chinese Children with Mild Persistent Asthma: A Single-Center, Retrospective Study

Introduction: A very limited option of inhaled corticosteroids (ICSs) is approved for pediatric use in China because in children the use of ICSs for long periods is associated with dose-dependent growth reduction. Due to the lack of consensus on which is the best ICS-based treatment option to manage mild persistent asthma in children, the present study was performed to evaluate the efficacy and safety of budesonide (BUD)-based therapy vis-à-vis mometasone-based therapy in children with mild persistent asthma. Methods: A single-center, retrospective study was conducted in asthmatic children aged between 6 and 11 years. BUD and mometasone furoate (MF) were administered as per the approved dosing regimen using pressurized metered-dose inhalers via oral inhalation route for a period of 12 weeks. The study outcome was assessed in terms of the forced expiratory volume in 1 s (FEV₁), symptom scores, and nonoccurrence of side effects. Results: Among the 77 asthmatic children, 71 completed the study treatment and were used in carrying out the analysis. The improvement of spirometric parameters like FEV₁, Tiffeneau-Pinelli index (FEV1/forced vital capacity [FVC]), and peak expiratory flow (PEF) values observed in the MF cohort was significantly greater than those of the BUD cohort (p < 0.05 for all). An increase of approximately 12%/child was observed for FEV₁/FVC ratios for the BUD cohort and MF cohorts. After the 12-week study, the PEF_m and PEF_e values increased to about 50 L/min/child for the BUD cohort and about 98 L/min/child for the MF cohort. During the study, no asthma exacerbation event was observed in the MF cohort, whereas 1 child in the BUD cohort had asthma exacerbation in week 4. The use of rescue medication during the study was required for 16.2 and 6% of children, respectively, for BUD and MF cohorts. Owing to low dosing frequency, MF could provide a better treatment approach than BUD due to improved patient compliance. Conclusions: Although both drugs showed improvement in the quality of life of asthmatic children with manageable treatment-emergent adverse effects, the improvement was augmented in MF-treated children. Level of Evidence: The level of evidence was III. Technical Efficacy Stage: The technical efficacy stage was 4.

A randomized prospective study to compare the efficacy and safety of budesonide plus formoterol and tiotropium plus formoterol in patients having mild to moderate chronic obstructive pulmonary disease

Background: Chronic obstructive pulmonary disease (COPD) is a leading respiratory illness affecting the quality of lives around the world. The present study aims to compare the efficacy and safety of combination of inhaled corticosteroid (ICS) and long acting β2 agonist (LABA) with long acting β2 agonist and long acting muscarinic antagonist (LAMA) in treatment of mild to moderate COPD in a tertiary care hospital.Methods: Total 132 patients with COPD were recruited on the basis of inclusion and exclusion criteria for 8 weeks study from outpatient clinic. A complete pulmonary examination including spirometry examination was done to rule out severe and very severe forms of COPD. Spirometry was performed at the time of recruitment for evaluation of forced expiratory volume in one second (FEV1) and measurement of SpO2 at the time of recruitment at 2 weeks and 8 weeks. Appropriate statistical methods were used to compare the qualitative and quantitative primary and secondary efficacy end points, p value &lt;0.05 was considered significant.Results: On analysis, there was a significant difference (p&lt;0.05) was observed in FEV1 and SpO2 from baseline in ICS plus LABA group (n=66). A similarly significant difference (p&lt;0.05) was observed in LABA and LAMA group (n=66). On comparison between ICS plus LABA and LABA plus LAMA no significant difference in FEV1 and SpO2 was observed between the two groups. More adverse drug reactions were observed in ICS plus LABA group than LAMA plus LABA group.Conclusions: Combination of ICS and LABA combination is as effective as combination of LABA and LAMA in patients having mild to moderate COPD. However, LABA and LAMA combination is preferable because it is associated with fewer side effects.

465 A Pharmacokinetic Bridging Study to Compare the Bioavailability of Budesonide Between Budesonide Oral Suspension and ENTOCORT EC in Healthy Subjects

INTRODUCTION: Budesonide oral suspension (BOS; TAK-721) is a viscous formulation of budesonide that is in development for the treatment of eosinophilic esophagitis in adults and adolescents. BOS was granted Breakthrough Designation by the FDA and is currently being evaluated in phase 3 trials. Several budesonide products are approved in the US for other indications, including ENTOCORT EC for mild to moderate active Crohn's disease; thus, the safety of budesonide has been evaluated extensively. The present study compared the bioavailability of BOS with ENTOCORT EC, aiming to provide the pharmacokinetic (PK) bridge to the safety data of ENTOCORT EC. METHODS: Healthy adults (n=22) were enrolled in an open-label, single-center, crossover study. Subjects received two treatments in a randomized sequence with a 48 h washout period between treatments: a single oral dose of BOS 2 mg and a single oral dose of ENTOCORT EC 9 mg. Serial blood samples were collected in each treatment period to determine plasma budesonide concentrations. PK parameters were calculated by non-compartmental analysis and compared between treatments using a mixed effects model with sequence and treatment as fixed effects and subject within sequence as a random effect. RESULTS: Plasma budesonide concentrations showed a faster absorption from BOS compared with ENTOCORT EC. Peak plasma concentrations were achieved ∼1.5 h post-dose for BOS and ∼4 h post-dose for ENTOCORT EC. Systemic exposure to budesonide after a single dose of BOS 2 mg was lower than that observed after a single dose of ENTOCORT EC 9 mg: the geometric mean AUC0-t, AUC0-inf and Cmax of budesonide after BOS 2 mg were 33.6%, 32.9% and 71.1% of those after ENTOCORT EC 9 mg, respectively. CONCLUSION: ENTOCORT EC 9 mg once daily (qd) is approved for induction treatment of Crohn's disease. The proposed clinical dosing regimen for BOS for induction treatment of eosinophilic esophagitis is 2 mg twice daily (bid). When taking into account the different dosing frequencies, the daily AUC and the Cmax of budesonide from BOS 2 mg bid at steady state are estimated to be 67% and 71% of those from ENTOCORT EC 9 mg qd, respectively. These results provide PK bridging data to compare BOS 2 mg bid to ENTOCORT EC with respect to safety information.

Benefit:Risk Profile of Budesonide in Obstructive Airways Disease.

Airway inflammation is a major contributing factor in both asthma and chronic obstructive pulmonary disease (COPD) and represents an important target for treatment. Inhaled corticosteroids (ICS) as monotherapy or in combination therapy with long-acting β2-agonists or long-acting muscarinic antagonists are used extensively in the treatment of asthma and COPD. The development of ICS for their anti-inflammatory properties progressed through efforts to increase topical potency and minimise systemic potency and through advances in inhaled delivery technology. Budesonide is a potent, non-halogenated ICS that was developed in the early 1970s and is now one of the most widely used lung medicines worldwide. Inhaled budesonide’s physiochemical and pharmacokinetic/pharmacodynamic properties allow it to reach a rapid and high airway efficacy due to its more balanced relationship between water solubility and lipophilicity. When absorbed from the airways and lung tissue, its moderate lipophilicity shortens systemic exposure, and its unique property of intracellular esterification acts like a sustained release mechanism within airway tissues, contributing to its airway selectivity and a low risk of adverse events. There is a large volume of clinical evidence supporting the efficacy and safety of budesonide, both alone and in combination with the fast- and long-acting β2-agonist formoterol, as maintenance therapy in patients with asthma and with COPD. The combination of budesonide/formoterol can also be used as an as-needed reliever with anti-inflammatory properties, with or without regular maintenance for asthma, a novel approach that is already approved by some country-specific regulatory authorities and currently recommended in the Global Initiative for Asthma (GINA) guidelines. Budesonide remains one of the most well-established and versatile of the inhaled anti-inflammatory drugs. This narrative review provides a clinical reappraisal of the benefit:risk profile of budesonide in the management of asthma and COPD.

Budesonide treatment for microscopic colitis: systematic review and meta-analysis.

Microscopic colitis (MC), encompassing lymphocytic and collagenous colitis, is a common cause for chronic nonbloody diarrhoea, which impacts significantly on the quality of life for patients. Despite increasing awareness of the condition and its treatment, there is considerable variation in therapeutic approaches. To conduct a systematic review and meta-analysis on the efficacy and safety of budesonide in the treatment of MC. We searched Medline, Embase and Central databases using predefined search methodology for randomised trials using budesonide in the treatment of MC. We extracted data, on the efficacy and safety of budesonide, from studies identified that met the feasibility for analysis criteria. These data were pooled with a fixed effects model. Nine studies met the inclusion criteria for analysis. The pooled odds ratios (ORs) for a response to budesonide therapy at induction and maintenance were 7.34 [95% confidence interval (CI): 4.08-13.19] and 8.35 (95% CI: 4.14-16.85) respectively. Histological response rates were superior in budesonide-treated patients compared to placebo following induction (OR: 11.52; 95% CI: 5.67-23.40) and maintenance treatment (OR: 5.88; 95% CI: 1.90-18.17). There was no difference in adverse events. Significant relapse rates (>50%) were observed following treatment cessation with no difference noted between the budesonide or the placebo-treated patients. Budesonide is an effective treatment option for MC for achieving induction and maintenance of both clinical and histological response. High relapse rates on treatment cessation were observed.

Efficacy and Safety of Budesonide in the Treatment of Eosinophilic Esophagitis: Updated Systematic Review and Meta-Analysis of Randomized and Non-Randomized Studies.

Background and ObjectiveEosinophilic esophagitis (EE) is an immune/antigen-driven inflammation that causes esophageal dysfunction. Budesonide has shown promising effect in the management of EE in multiple studies, and we therefore conducted this systematic review/meta-analysis to assess budesonide efficacy and safety in order to provide more updated and robust evidence.MethodsIn April 2018, we conducted a systematic electronic search through four databases: PubMed, Scopus, Web of Science (ISI), and Cochrane Central. All original studies reporting the efficacy of budesonide in the treatment of EE were included in our meta-analysis. The Cochrane Collaboration tool was employed to assess the risk of bias among included randomized controlled trials, while the Newcastle–Ottawa Scale was used for non-randomized studies.ResultsA total of 12 studies including 555 participants were included in our review. Budesonide showed marked efficacy at the level of histological response compared to placebo [risk ratio (RR) (95% confidence interval (CI)) 11.93 (4.82–29.50); p > 0.001]. Analysis of randomized and non-randomized studies revealed considerable reduction in eosinophil count, with a mean difference (MD) (95% CI) of − 69.41 (− 105.31 to − 33.51; p < 0.001) and 46.85 (33.93–59.77; p < 0.001), respectively. Similarly, there was a marked improvement in the clinical symptoms via the analysis of randomized and non-randomized studies, with an RR (95% CI) of 1.72 (1.22–2.41; p = 0.002) and MD (95% CI) of 2.45 (0.76–4.15; p = 0.005), respectively.ConclusionBudesonide showed significant effect at all treatment endpoints. However, since budesonide carries a risk of candidiasis and our inferences are based only on a small number of included studies, more research is warranted to clarify these results.Electronic supplementary materialThe online version of this article (10.1007/s40268-018-0253-9) contains supplementary material, which is available to authorized users.

Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis

Lymphocytic colitis is a common cause of chronic, nonbloody diarrhea. However, the effects of treatment are unclear and randomized placebo-controlled trials were requested in a Cochrane review. We performed a randomized, placebo-controlled, multicenter study to evaluate budesonide and mesalazine as induction therapy for lymphocytic colitis. Patients with active lymphocytic colitis were randomly assigned to groups given budesonide 9 mg once daily (Budenofalk granules), mesalazine 3 g once daily (Salofalk granules), or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as ≤21 stools (including ≤6 watery stools), in the 7 days before week8. The final analysis included 57 patients (19 per group). Most patients were female (72%) and the mean age was 59 years. The proportion of patients in clinical remission at week 8 was significantly higher in the budesonide group than in the placebo group (intention-to-treat analysis, 79% vs 42%; P= .01). The difference in proportions of patients in clinical remission at week 8 between the mesalazine (63%) and placebo groups was not significant (P= .09). The proportion of patients with histologic remission at week 8 was significantly higher in the budesonide group (68%) vs the mesalazine (26%; P= .02) or placebo (21%; P= .008) groups. The incidence of adverse events was 47.4% in the budesonide group, 68.4% in the mesalazine group, and 42.1% in the placebo group. In a randomized multicenter study, we found oral budesonide 9 mg once daily to be effective and safe for induction of clinical and histologic remission in patients with lymphocytic colitis, compared with placebo. Oral mesalazine 3 g once daily was not significantly better than placebo. ClinicalTrials.gov no: NCT01209208.

Efficacy and Safety of Oral Budesonide in Patients with Active Crohn's Disease in Japan: A Multicenter, Double-Blind, Randomized, Parallel-Group Phase 3 Study

Background: US and European guidelines recommend budesonide for the treatment of mild-to-moderate active ileocolic Crohn's disease (CD). However, budesonide has not been approved, and mesalazine is widely used as first-line treatment in Japan. The objective of this study was to evaluate the efficacy and safety of budesonide in patients with mild-to-moderate active CD in Japan. Methods: In this phase 3 noninferiority study (NCT01514240), 112 patients with a baseline Crohn's Disease Activity Index (CDAI) score of 180-400 were randomized to budesonide or mesalazine for 8 weeks. Assessments included remission rate (CDAI score ≤150) at weeks 2, 4, and 8, change in CDAI score, health-related quality of life (measured using the Inflammatory Bowel Disease Questionnaire [IBDQ]), and tolerability. Results: The remission rate at week 8 was numerically higher in the budesonide group (30.4%) than in the mesalazine group (25.0%), and the noninferiority of budesonide to mesalazine was shown. The mean total CDAI score decreased to a greater extent with budesonide than with mesalazine. Mean IBDQ scores improved from baseline to weeks 2, 4, 8, and 10 in both groups; improvements were numerically higher with budesonide than with mesalazine. No safety concerns were found. Conclusion: Budesonide is comparably effective to mesalazine in the treatment of Japanese patients with mild-to-moderate active CD.

Budesonide for the treatment of ulcerative colitis

ABSTRACTIntroduction: Budesonide is a synthetic corticosteroid characterized by enhanced topical potency and limited systemic bioavailability. Its use in ulcerative colitis (UC) was limited to rectal preparations until recently when the new oral budesonide formulation incorporating the multi-matrix system technology was introduced. The purpose of this review is to evaluate the current role of oral and rectal budesonide in managing UC patientsAreas covered: In this paper, we described the chemical structure and pharmacologic characteristics of the different oral and rectal budesonide preparations, provided a summary of the published trials that evaluated the efficacy and safety of budesonide in UC, and discussed the current status of its use in this populationExpert opinion: Budesonide is effective in inducing remission in a subset of patients with mild-moderate UC. Nevertheless, the current evidence suggests inferiority of oral budesonide to 5-aminosalisylates (5-ASA) and systemic steroids, whereas rectal applications are comparable to other rectal steroid preparations, but still inferior to rectal 5-ASA. In clinical practice, several issues need clarification including, its exact position in the line of induction agents; the role of combining budesonide and 5-ASAs; the role of combining oral and rectal budesonide; and the role of budesonide in maintenance therapy.

Efficacy of budesonide in collagenous colitis

Introduction: Collagenous colitis (CC) is a less common colonic disease with variable prevalence and undulating course. Among the available therapies, budesonide was demonstrated to induce a rapid and sustained remission in many cases, but little is known about the comparative efficacy of other treatments, such as mesalamine.Areas covered: Evaluation of a randomized study assessing the efficacy and safety of budesonide over mesalamine in patients with CC.Expert opinion: Data from the study showed that budesonide was significantly superior to placebo and to mesalamine and further supports the recommendation of the current guidelines on the use of budesonide in CC. However, other forms of mesalamine may further be evaluated for this disease.

Improved lung delivery of budesonide from biopolymer based dry powder inhaler through natural inhalation of rat

Budesonide, an inhaled glucocorticoid, is used for the treatment of large and small calibre airway inflammation associated with asthma. Conventional dry powder inhalers (DPIs) show least deposition efficiency in the lung due to agglomeration, increased particle size and minimum fluidisation. There is a need for controlled release budesonide DPI in order to improve maximum lung deposition with least toxicity and improve patient compliance. Budesonide loaded biopolymer based microparticles were prepared by controlled gelation of sodium alginate using calcium chloride and chitosan. Microparticles were evaluated for physical characteristics, in vitro lung deposition by Andersen cascade impactor and in vivo regional lung deposition by fabricated apparatus with measured respiratory minute volume of rats from plethysmography. The effect of DPI on the histology of lung tissues was also studied. The particle size, encapsulation efficiency, ζ potential, mass median aerodynamic diameter and fine particle fraction of the DPI were 3·059±0·03 μm, 87·16±1·11%, −17·5 mV, 1·16±0·01 μm and 56·18±0·01% respectively, which revealed the potential for pulmonary delivery. Formulation demonstrated a 14-fold increased drug deposition in the lung as compared to commercial DPI indicating pulmonary targeting potential. The formulation showed the controlled drug release up to 24 h. The histopathology revealed safety of the formulation. Developed DPI markedly improved regional lung deposition and safety of budesonide. This technology would facilitate the administration of glucocorticoid in the clinical testing.

Combination formoterol and budesonide as maintenance and reliever therapy versus current best practice (including inhaled steroid maintenance), for chronic asthma in adults and children.

Combination formoterol and budesonide as maintenance and reliever therapy versus current best practice (including inhaled steroid maintenance), for chronic asthma in adults and children.

Active Eosinophilic Esophagitis Is Associated with Impaired Elimination of Budesonide by Cytochrome P450 3A Enzymes

Background/Aims: Topically administered glucocorticoids such as budesonide have the potential of being established as first-line medical treatment of eosinophilic esophagitis (EoE). Safety of budesonide is based on high elimination by cytochrome P450 3A (CYP3A) enzymes. We aimed to investigate systemic absorption and elimination of a new budesonide formulation in patients with active EoE in comparison with healthy controls. Methods: After single and multiple doses of orodispersible budesonide (4 mg/day) the parent drug, its CYP3A-dependent metabolites, and endogenous cortisol were determined in 12 adult patients with active EoE and 12 healthy controls. An approved ileal-release formulation of budesonide was taken for reference. Molar ratios of metabolite formation in plasma were used as indices of CYP3A metabolic function. Results: CYP3A-dependent metabolite formation was significantly reduced in patients with active EoE as compared to healthy controls. Impaired biotransformation was reflected by a significantly higher extent of budesonide absorption and elongated elimination half-life in EoE patients. Comparison of morning serum cortisol levels at baseline with those after 1 week of treatment with budesonide revealed a significant decrease in EoE patients but not in healthy subjects. Conclusion: Active EoE is associated with reduced elimination of budesonide via CYP3A, the major subfamily of drug-metabolizing enzymes in humans.

Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease

Objective:To evaluate the efficacy and safety of budesonide (BUD)/formoterol (FORM) compared with BUD, both administered by way of a dry powder inhaler (Turbuhaler).* Turbuhaler is a registered trade name of AstraZeneca, Södertälje, Sweden.Methods:This was a 6-month, multicenter, randomized, parallel-group, double-blind, double-dummy design study (NCT 00421122). Patients were randomized to either BUD/FORM 160/4.5 μg, two inhalations twice daily, or BUD 200 μg, two inhalations twice daily. Improvement of lung function, daily symptoms, reliever use and health-related quality-of-life (St George’s Respiratory Questionnaire [SGRQ] score) were compared between the two treatment groups.Results:A total of 308 patients with moderate to very severe COPD from 12 centers in China were randomized to BUD/FORM (n = 156) or BUD (n = 152). The primary endpoint, 1-hour post-dose forced expiratory volume in 1 second (FEV1), in the BUD/FORM group improved by 0.18 L (from 0.83 L at baseline to 1.01 L) and this was significantly better (p < 0.001) than the small increase (0.03 L) observed in the BUD group after 24 weeks’ treatment. Increases in pre-dose and 15-min post-dose FEV1 together with 1-hour post-dose forced vital capacity were also significantly larger with BUD/FORM than BUD (p < 0.001 for all). Compared with BUD alone, BUD/FORM improved COPD total symptom scores (−1.04 ± 0.16 vs. −0.55 ± 0.17; p = 0.03), reduced reliever use (−0.85 ± 0.16 puffs/day vs. −0.31 ± 0.16 puffs/day; p = 0.012) and improved health-related quality-of-life (mean change of total SGRQ score −4.5 points (p = 0.0182). Overall, both treatments were well tolerated.Conclusions:In Chinese patients with moderate to very severe COPD, fixed combination treatment with BUD/FORM resulted in clinically meaningful improvements in lung function, health-related quality-of-life, COPD symptoms and a reduction in reliever use, compared with BUD alone and both treatments were well tolerated. Treatment of BUD/FORM for milder patients with COPD and head to head comparison of Chinese and Caucasians in future studies will be helpful to expand upon the findings of the current clinical trial.

Oral budesonide for maintenance of remission of Crohn’s disease: a pooled safety analysis

Budesonide exhibits similar efficacy to systemic glucocorticosteroids (GCSs) in Crohn's disease (CD), but with fewer adverse events (AEs). Aim To evaluate budesonide's safety profile in CD patients, in particular, incidences of clinically important AEs known to be associated with systemic GCSs. Five 1-year, double-blind, placebo-controlled trials evaluating budesonide for mild-to-moderate CD were pooled for analysis. The highest incidence rates of AEs were gastrointestinal- and endocrine systems-related in both groups (budesonide 6 mg/day, n = 208; placebo, n = 209). Incidence rates were similar, except for higher incidence of endocrine disorders in budesonide versus placebo patients (P = 0.0042) caused by a higher overall occurrence of cutaneous GCS symptoms (P = 0.0036) in the budesonide group; differences in individual symptoms were nonsignificant. Percentage of patients with normal adrenal function was significantly lower at 13 weeks (three of five studies), but not at 52 weeks (two studies) in the budesonide versus placebo groups. Occurrence of clinically important or serious AEs associated with systemic GCSs, including sepsis, cataracts, adrenal insufficiency was rare and similar between groups. Budesonide treatment for up to 1 year is well-tolerated in CD patients, with an AE profile similar to placebo and only rare occurrences of clinically important AEs associated with systemic GCSs.

Efficacy and Safety of Budesonide and Formoterol in Asthma

Efficacy and Safety of Budesonide and Formoterol in Asthma

Evaluation of efficacy and safety of budesonide delivered via two dry powder inhalers

ABSTRACTBackground: The dry powder inhaler (DPI) device for budesonide inhalation powder 200 μg (DPI‑A) was redesigned to improve dosing consistency and provide new features (budesonide inhalation powder 90 μg and 180 μg; DPI‑B).Objective: Two multicenter, parallel-group, double-blind, randomized, 12-week studies compared the efficacy and safety of budesonide delivered via each DPI versus placebo, and the systemic exposure of budesonide from each device.Methods: Asthmatic adults with mild-to-moderate asthma (N = 621) and patients 6–17 years with mild asthma (N = 516) received budesonide DPI‑B 360 μg or DPI‑A 400 μg twice-daily (total daily dose 720 μg or 800 μg), budesonide DPI‑B 180 μg or DPI‑A 200 μg once daily (total daily dose 180 μg or 200 μg), or matching placebo. Change in forced expiratory volume in 1 second (FEV1) and secondary variables (asthma symptoms, β2-adrenergic agonist use, peak expiratory flow [PEF], and withdrawals due to worsening asthma) versus placebo were measured.Results: In both studies, FEV1 significantly ( p < 0.05) improved for all active treatments versus placebo except once-daily budesonide DPI‑B 180 μg in adults. In the adult study, significantly ( p < 0.05) greater improvements in all secondary variables occurred with all active treatments versus placebo. In the pediatric/adolescent study, improvements in AM/PM PEF were significantly (p ≤ 0.011) greater with twice-daily budesonide DPI‑B 360 μg versus placebo. Numerically fewer patients in all active-treatment groups withdrew due to worsening asthma versus placebo.Adverse event profiles were similar among groups. In the pediatric/adolescent study, no significant differences in mean 24-h urine cortisol or cortisol : creatinine ratio assessments were observed between the active treatment groups and the placebo group. Although pharmacokinetic variables were generally similar across subgroups in the adult (n = 77) and pediatric/adolescent (n = 32) studies, pairwise treatment comparisons of twice-daily budesonide DPI‑B 360 μg versus DPI‑A 400 μg and once-daily budesonide DPI‑B 180 μg versus DPI‑A 200 μg showed large variability for the area under the drug plasma concentration–time curve over the dosing interval and the maximum detected drug plasma concentration.Conclusions: The efficacy and safety of budesonide DPI‑A and DPI‑B versus placebo were demonstrated across the low to medium inhaled corticosteroid dose range in children ≥ 6 years with very mild asthma and adolescents and adults with mild-to-moderate asthma. The study is limited by the evaluation of only two doses for each product in both studies. Additionally, the studies were not designed to test equivalence or noninferiority between the active products. Pharmacokinetic characterization was limited because of the small sample sizes.