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Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia Bronchopulmonary dysplasia (BPD) is an important complication of mechanical ventilation in preterm infants, and no definite therapy can eliminate this complication. Pulmonary inflammation plays a crucial role in its pathogenesis, and glucocorticoid is one potential therapy to prevent BPD.To compare the effect of intratracheal administration of surfactant/budesonide with that of surfactant alone (...) on the incidence of death or BPD.A clinical trial was conducted in three tertiary neonatal centers in the United States and Taiwan, in which 265 very-low-birth-weight infants with severe respiratory distress syndrome who required mechanical ventilation and inspired oxygen (fraction of inspired oxygen, ≥50%) within 4 hours of birth were randomly assigned to one of two groups (131 intervention and 134 control). The intervention infants received surfactant (100 mg/kg) and budesonide (0.25 mg/kg), and the control
Oral budesonide for induction of remission in ulcerative colitis. Corticosteroids are first-line therapy for induction of remission in ulcerative colitis. Although corticosteroids may improve symptoms, they have significant adverse effects. Steroids which act topically, with less systemic side-effects may be more desirable. Budesonide is a topically acting corticosteroid with extensive first pass hepatic metabolism. There are currently three formulations of budesonide: two standard formulations (...) including a controlled-ileal release capsule and a pH-dependent capsule both designed to release the drug in the distal small intestine and right colon; and the newer Budesonide-MMX® capsule designed to release the drug throughout the entire colon.The primary objective was to evaluate the efficacy and safety of oral budesonide for the induction of remission in ulcerative colitis.We searched MEDLINE, EMBASE, CENTRAL, and the Cochrane IBD Group Specialised Register from inception to April 2015. We also
Early Inhaled Budesonide for the Prevention of Bronchopulmonary Dysplasia. Systemic glucocorticoids reduce the incidence of bronchopulmonary dysplasia among extremely preterm infants, but they may compromise brain development. The effects of inhaled glucocorticoids on outcomes in these infants are unclear.We randomly assigned 863 infants (gestational age, 23 weeks 0 days to 27 weeks 6 days) to early (within 24 hours after birth) inhaled budesonide or placebo until they no longer required oxygen (...) and positive-pressure support or until they reached a postmenstrual age of 32 weeks 0 days. The primary outcome was death or bronchopulmonary dysplasia, confirmed by means of standardized oxygen-saturation monitoring, at a postmenstrual age of 36 weeks.A total of 175 of 437 infants assigned to budesonide for whom adequate data were available (40.0%), as compared with 194 of 419 infants assigned to placebo for whom adequate data were available (46.3%), died or had bronchopulmonary dysplasia (relative risk
Budesonide/Formoterol for bronchiolitis obliterans after hematopoietic stem cell transplantation Systemic steroids are the standard treatment for bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic stem cell transplantation (HSCT) despite their poor efficacy and disabling side effects.To evaluate the effectiveness and tolerance of budesonide/formoterol as an alternative treatment for BOS after HSCT.In this randomized, double-blind, placebo-controlled study, we randomly (...) assigned 32 HSCT recipients with mild/severe BOS to receive budesonide/formoterol or placebo for 6 months. The primary outcome was the change in the FEV1 after 1 month of treatment (M1) compared with the baseline value. Patients were unblinded at M1 if there was no improvement in the FEV1. Those who had initially received placebo were switched to budesonide/formoterol. Intention-to-treat analysis was performed to assess the primary outcome. Additional analyses took scheduled treatment contamination
Nebulised budesonide using a novel device in patients with oral steroid-dependent asthma This phase 2/3 randomised, parallel-group, placebo-controlled trial investigated oral corticosteroid (OCS)-sparing efficacy, safety and tolerability of nebulised budesonide (Bud) administered with a novel computer-controlled, compressor-driven inhalation system (AKITA) as add-on therapy to Global Initiative for Asthma step 5. Patients (18-65 years) with OCS-dependent asthma were randomised (2:1:1:1 (...) forced expiratory volume in 1 s improved (from baseline to week 18) for AICS-Bud 1 mg (239±460 mL, p<0.001) and AICS-Bud 0.5 mg (126±345 mL, p=0.01) but not placebo (93±419 mL, p=0.36) or CN-Bud (137±459 mL, p=0.18). Fewer AICS-Bud 1 mg-treated patients experienced asthma exacerbations (7.5%) compared with placebo (17.5%) or CN-Bud (22.5%). All treatments were well tolerated. Budesonide applied with AKITA allowed significant meaningful OCS reduction in OCS-dependent asthma patients while improving
Budesonide for induction of remission in Crohn's disease. Corticosteroids are commonly used for the induction of remission in Crohn's disease. However, traditional corticosteroids can cause significant adverse events. Budesonide is an alternative glucocorticoid with limited systemic bioavailability.The primary objective was to evaluate the efficacy and safety of oral budesonide for the induction of remission in Crohn's disease.The following electronic databases were searched up to June 2014 (...) : MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane IBD/FBD Group Specialised Trial Register, and ClinicalTrials.gov. Reference lists of articles, as well as conference proceedings were manually searched.Randomised controlled trials comparing budesonide to a placebo or active comparator were considered for inclusion.Two independent investigators reviewed studies for eligibility, extracted the data and assessed study quality. Methodological quality was assessed using
Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis Budesonide is a high-potency, second-generation corticosteroid designed to minimize systemic adverse consequences of conventional corticosteroids. We performed 2 randomized, phase 3 trials to evaluate the ability of budesonide rectal foam, formulated to optimize retention and provide uniform delivery of budesonide to the rectum and distal colon, to induce remission (...) in patients with ulcerative proctitis or ulcerative proctosigmoiditis.Two identically designed, randomized, double-blind, placebo-controlled trials evaluated the efficacy of budesonide foam for induction of remission in 546 patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis who received budesonide foam 2 mg/25 mL twice daily for 2 weeks, then once daily for 4 weeks, or placebo.Remission at week 6 occurred significantly more frequently among patients receiving budesonide
Ulcerative colitis: budesonide multimatrix (Cortiment) Ulcer Ulcerativ ative colitis: budesonide multimatrix e colitis: budesonide multimatrix ( (Cortiment) Cortiment) Evidence summary Published: 16 June 2015 nice.org.uk/guidance/esnm58 pathways K Ke ey points from the e y points from the evidence vidence The content of this evidence summary was up-to-date in June 2015. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up- to-date (...) information. Summary Budesonide multimatrix (MMX, Cortiment) is a corticosteroid that is taken orally but exerts its action topically in the colon. In two 8-week studies, budesonide MMX statistically significantly increased rates of combined clinical and endoscopic remission in adults with mild to moderate ulcerative colitis compared with placebo. However the effect size was small and the clinical relevance of the improvements is unclear. There was no statistically significant difference between
Effect of budesonide transnasal nebulization in patients with eosinophilic chronic rhinosinusitis with nasal polyps There is little evidence on the efficacy of glucocorticoid transnasal nebulization therapy in patients with eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP).We sought to evaluate the immunologic and remodeling effects of budesonide transnasal nebulization in patients with eosinophilic CRSwNP.Sixty patients with eosinophilic CRSwNP were randomized to receive (...) budesonide or placebo treatment for 14 days by means of transnasal nebulization in a double-blind manner. Endoscopic polyp size scores (maximum = 6 points, Kennedy score) and visual analog scale scores for nasal symptoms were assessed before and after treatment. Similarly, polyp samples were evaluated for inflammatory cytokines, matrix metalloproteinases (MMPs), and tissue inhibitors of metalloproteinases (TIMPs) by using an immunoassay; collagen by using histochemistry; eosinophils by using hematoxylin
Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial This 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis.A prospective, randomised, placebo-controlled study beginning with an 8-week open-label induction phase in which patients with histologically confirmed active collagenous colitis received budesonide (Budenofalk, 9 mg/day initially (...) , tapered to 4.5 mg/day), after which 92 patients in clinical remission were randomised to budesonide (mean dose 4.5 mg/day; Budenofalk 3 mg capsules, two or one capsule on alternate days) or placebo in a 12-month double-blind phase with 6 months treatment-free follow-up. Primary endpoint was clinical remission throughout the double-blind phase.Clinical remission during open-label treatment was achieved by 84.5% (93/110 patients). The median time to remission was 10.5 days (95% CI (9.0 to 14.0 days
Inhaled budesonide and oral dexamethasone prevent acute mountain sickness This double-blind, randomized controlled trial aimed to investigate inhaled budesonide and oral dexamethasone compared with placebo for their prophylactic efficacy against acute mountain sickness after acute high-altitude exposure.There were 138 healthy young male lowland residents recruited and randomly assigned to receive inhaled budesonide (200 μg, twice a day [bid]), oral dexamethasone (4 mg, bid), or placebo (46 (...) in each group). They traveled to 3900 m altitude from 400 m by car. Medication started 1 day before high-altitude exposure and continued until the third day of exposure. Primary outcome measure was the incidence of acute mountain sickness after exposure.One hundred twenty-four subjects completed the study (42, 39, and 43 in the budesonide, dexamethasone, and placebo groups, respectively). Demographic characteristics were comparable among the 3 groups. After high-altitude exposure, significantly fewer
Budesonide for maintenance of remission in Crohn's disease. Corticosteroids are effective for induction, but not maintenance of remission in Crohn's disease. Significant concerns exist regarding the risk for adverse events, particularly when corticosteroids are used for long treatment courses. Budesonide is a glucocorticoid with limited systemic bioavailability due to extensive first-pass hepatic metabolism and is effective for induction of remission in Crohn's disease.To evaluate the efficacy (...) and safety of oral budesonide for maintenance of remission in Crohn's disease.The following databases were searched from inception to 12 June 2014: PubMed, MEDLINE, EMBASE, CENTRAL, the Cochrane IBD/FBD Group Specialised Trial Register, and ClinicalTrials.gov. Reference lists of articles, as well as conference proceedings were manually searched.Randomized controlled trials comparing budesonide to a control treatment, or comparing two doses of budesonide, were included. The study population included
Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis Studies reporting that budesonide is effective for the treatment of collagenous colitis have been small and differed in efficacy measures. Mesalamine has been proposed as a treatment option for collagenous colitis, although its efficacy has never been investigated in placebo-controlled trials. We performed a phase 3, placebo-controlled, multicenter study to evaluate budesonide and mesalamine (...) as short-term treatments for collagenous colitis.Patients with active collagenous colitis were randomly assigned to groups given pH-modified release oral budesonide capsules (9 mg budesonide once daily, Budenofalk, n = 30), mesalamine granules (3 g mesalamine once daily, Salofalk, n = 25), or placebo for 8 weeks (n = 37) in a double-blind, double-dummy fashion. The study was conducted in 31 centers (hospital clinics and private practices) in Germany, Denmark, Lithuania, Spain, and the United Kingdom
DuoResp Spiromax - budesonide / formoterol 20 February 2014 EMA/CHMP/175692/2014 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report DuoResp Spiromax International non-proprietary name: Budesonide / formoterol Procedure No. EMEA/H/C/002348 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 (...) 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail email@example.com Website www.ema.europa.eu Product information Name of the medicinal product: DuoResp Spiromax Applicant: Teva Pharma B.V. Computerweg 10 3542DR Utrecht NETHERLANDS Active substance: BUDESONIDE / FORMOTEROL FUMARATE DIHYDRATE International Non proprietary Name: Budesonide / formoterol Pharmaco-therapeutic group (ATC Code): Formoterol and other drugs for obstructive airway diseases (R03AK07) Therapeutic indication(s): DuoResp Spiromax
BiResp Spiromax (budesonide / formoterol fumarate dihydrate) 20 February 2014 EMA/CHMP/175684/2014 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report BiResp Spiromax International non-proprietary name: Budesonide / formoterol Procedure No. EMEA/H/C/003890 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union (...) Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail firstname.lastname@example.org Website www.ema.europa.eu Product information Name of the medicinal product: BiResp Spiromax Applicant: Teva Pharma B.V. Computerweg 10 3542DR Utrecht NETHERLANDS Active substance: BUDESONIDE / FORMOTEROL FUMARATE DIHYDRATE International Non proprietary Name/Common Name: Budesonide / formoterol Pharmaco-therapeutic group (ATC Code): Formoterol and other drugs for obstructive airway diseases (R03AK07) Therapeutic
Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children. Asthma is characterised by chronic inflammation of the airways and recurrent exacerbations with wheezing, chest tightness and cough. Treatment with inhaled steroids and bronchodilators often results in good control of symptoms, prevention of further morbidity and mortality and improved quality of life. Several steroids and beta2-agonists (...) (long- and short-acting) as well as combinations of these treatments are available in a single inhaler to be used once or twice a day, with a separate inhaler for relief of symptoms when needed (for patients in Step three or higher, according to Global Initiative for Asthma (GINA) guidelines). Budesonide/formoterol is also licenced for use as maintenance and reliever therapy from a single inhaler (SiT; sometimes referred to as SMART therapy). SiT can be prescribed at a lower dose than other
Combination formoterol and budesonide as maintenance and reliever therapy versus current best practice (including inhaled steroid maintenance), for chronic asthma in adults and children. Traditionally inhaled treatment for asthma has used separate preventer and reliever therapies. The combination of formoterol and budesonide in one inhaler has made possible a single inhaler for both prevention and relief of symptoms (single inhaler therapy or SiT).To assess the efficacy and safety of budesonide (...) and formoterol in a single inhaler for maintenance and reliever therapy in asthma compared with maintenance with inhaled corticosteroids (ICS) (alone or as part of current best practice) and any reliever therapy.We searched the Cochrane Airways Group trials register in February 2013.Parallel, randomised controlled trials of 12 weeks or longer in adults and children with chronic asthma. Studies had to assess the combination of formoterol and budesonide as SiT, against a control group that received inhaled