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Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. Concerns remain about the safety of adding long-acting β2-agonists to inhaled glucocorticoids for the treatment of asthma. In a postmarketing safety study mandated by the Food and Drug Administration, we evaluated whether the addition of formoterol to budesonide maintenance therapy increased the risk of serious asthma-related events in patients with asthma.In this multicenter, double-blind, 26-week study, we randomly (...) assigned patients, 12 years of age or older, who had persistent asthma, were receiving daily asthma medication, and had had one to four asthma exacerbations in the previous year to receive budesonide-formoterol or budesonide alone. Patients with a history of life-threatening asthma were excluded. The primary end point was the first serious asthma-related event (a composite of adjudicated death, intubation, and hospitalization), as assessed in a time-to-event analysis. The noninferiority of budesonide
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
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 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
events and glucocorticoid adverse events seen with budesonide MMX were not substantially different from placebo in the 2 RCTs. P Patient factors atient factors Alternative treatments are available for use orally and rectally, in a number of different formulations. Budesonide MMX is not licensed for maintenance of remission in ulcerative colitis. Other budesonide preparations (Entocort and Budenofalk) are not licensed for ulcerative colitis. It is not known how budesonide MMX compares with other (...) : the products included in table 2 are the most commonly prescribed individual drugs and formulations (oral and topical) based on the NHS prescription cost analysis for England 2013. Other oral budesonide preparations licensed for use in Crohn's disease (Entocort CR and Budenofalk) release the drug in the distal ileum and right colon, do not deliver budesonide to the left colon and, therefore, are not optimally designed for the treatment of patients with ulcerative colitis. Neither of these products
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
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 (...) 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
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 firstname.lastname@example.org 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 email@example.com 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
xinafoate are available as single, dry powder inhalation products, e.g. Pulmicort Turbohaler (100, 200, and 400 mcg) and Serevent powder for inhalation (50 mcg). The application is based on new clinical study results relating to this fixed combination. The maximum daily dose is 480 mcg budesonide and 40 mcg salmeterol. It should be noted that the data submitted in the application dossier referred to Labazenit 150 µg/25 µg and 300 µg/25 µg as the finished medicinal product, which corresponds (...) products available during early development of the proposed formulations were Pulmicort Turbohaler for budesonide (200 µg) and Serevent Discus (50 µg) for salmeterol. The goal was to reach similar in vitro lung deposition characteristics for labazenit as for the reference products. Due to the addition of lactose monohydrate to the excipient blend, lower capsule content of active substance is required to achieve comparable fine particle dose to the comparator products (salmeterol: 25 µg vs. 50 µg
Clinical efficacy and safety of budesonide-formoterol in non-cystic fibrosis bronchiectasis The aim of this study is to evaluate the efficacy and safety of medium-dose formoterol-budesonide combined inhaled treatment in a single inhaler compared with high-dose budesonide treatment in patients with non-cystic fibrosis (non-CF) bronchiectasis.This is a 12-month randomized, double-blind, parallel-groups clinical trial, to run in 40 patients with non-CF bronchiectasis diagnosed by high-resolution (...) CT scan of the chest, receiving formoterol-budesonide combined treatment (18/640 μg daily) or budesonide treatment (1,600 μg daily). Variables concerning clinical condition, health-related quality of life (HRQL), lung function, β(2)-adrenergic agonist use, potentially pathogenic microorganism (PPM) isolates, and medication side effects were analyzed by intention-to-treat analysis.The study group receiving a formoterol-budesonide combined treatment showed a significant improvement, both clinically
Once-daily budesonide MMX(R) extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study Budesonide is a corticosteroid with minimal systemic corticosteroid activity due to first-pass hepatic metabolism. Budesonide MMX® is a once-daily oral formulation of budesonide that extends budesonide release throughout the colon using multi-matrix system (MMX) technology.We performed a randomized, double-blind, double-dummy, placebo (...) -controlled trial to evaluate the efficacy of budesonide MMX for induction of remission in 509 patients with active, mild to moderate ulcerative colitis (UC). Patients were randomly assigned to groups that were given budesonide MMX (9 mg or 6 mg), mesalamine (2.4 g, as reference), or placebo for 8 weeks. The primary end point was remission at week 8.The rates of remission at week 8 among subjects given 9 mg or 6 mg budesonide MMX or mesalamine were 17.9%, 13.2%, and 12.1%, respectively, compared with 7.4