Latest & greatest articles for budesonide

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Top results for budesonide

21. Budesonide (Cortiment) - mild to moderate active ulcerative colitis

Budesonide (Cortiment) - mild to moderate active ulcerative colitis Published 12 October 2015 Product Update: budesonide 9mg prolonged release tablets (Cortiment ® ) SMC No. (1093/15) Ferring Pharmaceuticals 4 September 2015 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in Scotland. The advice is summarised as follows: ADVICE: following an abbreviated submission (...) budesonide (Cortiment ® ) is not recommended for use within NHS Scotland. Indication under review: in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient. In two, phase III, placebo-controlled studies, significantly higher proportions of patients achieved clinical and colonoscopic remission at week 8 with budesonide (Cortiment ® ) 9mg once daily compared to placebo. However, similar clinical effectiveness

Scottish Medicines Consortium2015

22. Budesonide/Formoterol for bronchiolitis obliterans after hematopoietic stem cell transplantation

Budesonide/Formoterol for bronchiolitis obliterans after hematopoietic stem cell transplantation 25835160 2015 06 02 2015 08 17 2015 11 19 1535-4970 191 11 2015 Jun 01 American journal of respiratory and critical care medicine Am. J. Respir. Crit. Care Med. Budesonide/Formoterol for bronchiolitis obliterans after hematopoietic stem cell transplantation. 1242-9 10.1164/rccm.201410-1818OC 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

EvidenceUpdates2015

23. Nebulised budesonide using a novel device in patients with oral steroid-dependent asthma

Nebulised budesonide using a novel device in patients with oral steroid-dependent asthma 25504995 2015 05 01 2016 04 06 2015 05 01 1399-3003 45 5 2015 May The European respiratory journal Eur. Respir. J. Nebulised budesonide using a novel device in patients with oral steroid-dependent asthma. 1273-82 10.1183/09031936.00152014 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) to receive 18-week, twice-daily, double-blind treatment with AKITA inhaled corticosteroid (AICS)-Bud 1 mg, AICS-Bud 0.5 mg, AICS-placebo or open-label Bud 1 mg administered by conventional nebuliser (CN-Bud). OCS doses were tapered until week 14. 199 patients started

EvidenceUpdates2015 Full Text: Link to full Text with Trip Pro

24. Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis

Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis 25644096 2015 03 25 2015 05 28 2015 08 07 1528-0012 148 4 2015 Apr Gastroenterology Gastroenterology Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. 740-750.e2 10.1053/j.gastro.2015.01.037 S0016-5085(15)00154-7 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

EvidenceUpdates2015 Full Text: Link to full Text with Trip Pro

26. Effect of budesonide transnasal nebulization in patients with eosinophilic chronic rhinosinusitis with nasal polyps

Effect of budesonide transnasal nebulization in patients with eosinophilic chronic rhinosinusitis with nasal polyps 25483598 2015 04 06 2015 06 10 2015 04 06 1097-6825 135 4 2015 Apr The Journal of allergy and clinical immunology J. Allergy Clin. Immunol. Effect of budesonide transnasal nebulization in patients with eosinophilic chronic rhinosinusitis with nasal polyps. 922-29.e6 10.1016/j.jaci.2014.10.018 S0091-6749(14)01513-9 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

EvidenceUpdates2015 Full Text: Link to full Text with Trip Pro

27. Ulcerative colitis: budesonide multimatrix (Cortiment)

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

National Institute for Health and Clinical Excellence - Advice2015

28. Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial

Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial 25425655 2015 12 15 2016 04 04 2016 12 15 1468-3288 65 1 2016 Jan Gut Gut Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial. 47-56 10.1136/gutjnl-2014-308363 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

EvidenceUpdates2014 Full Text: Link to full Text with Trip Pro

29. Inhaled budesonide and oral dexamethasone prevent acute mountain sickness

Inhaled budesonide and oral dexamethasone prevent acute mountain sickness 24784698 2014 10 14 2014 12 15 2016 07 14 1555-7162 127 10 2014 Oct The American journal of medicine Am. J. Med. Inhaled budesonide and oral dexamethasone prevent acute mountain sickness. 1001-1009.e2 10.1016/j.amjmed.2014.04.012 S0002-9343(14)00351-9 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

EvidenceUpdates2014 Full Text: Link to full Text with Trip Pro

30. Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis

Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis 24440672 2014 04 18 2014 06 05 2014 10 30 1528-0012 146 5 2014 May Gastroenterology Gastroenterology Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis. 1222-30.e1-2 10.1053/j.gastro.2014.01.019 S0016-5085(14)00076-6 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

EvidenceUpdates2014 Full Text: Link to full Text with Trip Pro

31. Budesonide gastro-resistant granules (Budenofalk) - Crohn?s disease

Budesonide gastro-resistant granules (Budenofalk) - Crohn?s disease Published 09 June 2014 Product Update budesonide 9mg gastro-resistant granules (Budenofalk ® ) (No: 970/14) Dr Falk Pharma UK Limited 09 May 2014 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following an abbreviated submission budesonide (...) gastro-resistant granules (Budenofalk ® ) is accepted for use within NHS Scotland. Indication under review: induction of remission in patients with mild to moderate active Crohn’s disease affecting the ileum and/or ascending colon. Budesonide gastro-resistant granules provide a once daily alternative to budesonide gastro-resistant 3mg capsules three times daily at no additional cost. The granules may have advantages for patients who have difficulty swallowing. Advice context: No part of this advice

Scottish Medicines Consortium2014

32. DuoResp Spiromax - budesonide / formoterol

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 info@ema.europa.eu 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

European Medicines Agency - EPARs2014

33. Budesonide/Formoterol Teva Pharma B.V. (budesonide / formoterol)

Budesonide/Formoterol Teva Pharma B.V. (budesonide / formoterol) 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. 25 September 2014 EMA/CHMP/707217/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report (...) Budesonide/Formoterol Teva Pharma B.V. International non-proprietary name: budesonide / formoterol Procedure No. EMEA/H/C/003953 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Medicinal product no longer authorised Assessment report EMA/CHMP/707217/2014 Page 2/65 Administrative information Name of the medicinal product: Budesonide/Formoterol Teva Pharma B.V. Applicant: Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands Active

European Medicines Agency - EPARs2014

34. BiResp Spiromax (budesonide / formoterol fumarate dihydrate)

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 info@ema.europa.eu 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

European Medicines Agency - EPARs2014

35. Vylaer Spiromax - budesonide / formoterol

Vylaer Spiromax - budesonide / formoterol 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. 25 September 2014 EMA/CHMP/706811/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Vylaer Spiromax International (...) non-proprietary name: budesonide / formoterol Procedure No. EMEA/H/C/003952 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Medicinal product no longer authorised Assessment report EMA/CHMP/706811/2014 Page 2/65 Administrative information Name of the medicinal product: Vylaer Spiromax Applicant: Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands Active substance: budesonide / formoterol fumarate dihydrate International

European Medicines Agency - EPARs2014

36. Cohort study: Inhaled fluticasone and budesonide increased the risk of serious pneumonia in COPD

Cohort study: Inhaled fluticasone and budesonide increased the risk of serious pneumonia in COPD Inhaled fluticasone and budesonide increased the risk of serious pneumonia in COPD | Evidence-Based Medicine This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? Search for this keyword Search (...) for this keyword Main menu Log in using your username and password For personal accounts OR managers of institutional accounts Username * Password * your user name or password? You are here Inhaled fluticasone and budesonide increased the risk of serious pneumonia in COPD Article Text Harm Cohort study Inhaled fluticasone and budesonide increased the risk of serious pneumonia in COPD Patrick White Statistics from Altmetric.com No Altmetric data available for this article. Commentary on: Suissa S , Patenaude V

Evidence-Based Medicine (Requires free registration)2014

37. Budesonide (Budenofalk) Abbreviated - induction of remission in patients with active collagenous colitis

Budesonide (Budenofalk) Abbreviated - induction of remission in patients with active collagenous colitis Published 14 January 2013 Product Update: Budesonide 9mg gastro-resistant granules (Budenofalk®) (No 831/12) Dr Falk Pharma UK Ltd 07 December 2012 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following (...) an abbreviated submission Budesonide 9mg gastro-resistant granules (Budenofalk®) is accepted for use within NHS Scotland. Indication under review: induction of remission in patients with active collagenous colitis. Budesonide gastro-resistant granules provides a once daily alternative to budesonide gastro-resistant 3mg capsules (which are given three times daily) at no additional cost. The granules may have advantages for patients who have difficulty swallowing. Advice context: No part of this advice may

Scottish Medicines Consortium2013

39. Labazenit - budesonide / salmeterol

Labazenit - budesonide / salmeterol 27 June 2013 EMA/465765/2013 Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report Labazenit International non-proprietary names: budesonide/salmeterol Procedure No. EMEA/H/C/002201/0000 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 (...) needed. In patients with a history of multiple exacerbations there is a risk of long-term progressive decline in lung function. For all these reasons, additional treatment options are desirable. CHMP assessment report EMA/465765/2013 Page 7/181 Labazenit is a new fixed combination medicinal product containing two known components, salmeterol xinafoate and budesonide. Salmeterol and budesonide have different modes of action. Corticosteroid therapy, principally inhaled glucocorticosteroid (ICS

European Medicines Agency - EPARs2013

40. The Use of Budesonide MMX to Induce Remission in Active, Moderate to Mild Ulcerative Colitis: A Systematic Review

The Use of Budesonide MMX to Induce Remission in Active, Moderate to Mild Ulcerative Colitis: A Systematic Review "The Use of Budesonide MMX to Induce Remission in Active, Moderate to M" by Terence Potter < > > > > > Title Author Date of Award Fall 8-10-2013 Degree Type Capstone Project Degree Name Master of Science in Physician Assistant Studies First Advisor Robert Rosenow, Pharm.D., OD Second Advisor Annjanette Sommers, PA-C, MS Rights . Abstract Background: Ulcerative colitis (UC), a type (...) of inflammatory bowel disease characterized by diffuse colonic mucosal inflammation, accounts for over 250k physician visits annually with direct medical costs alone exceeding 4 billion dollars annually. The disease, whose etiology is not well understood, can have severe consequences such as colorectal cancer. First-line treatment for mild to moderate disease is topical 5-ASA agents such as mesalamine. Patients refractory to this treatment are candidates for oral steroids, but these can have severe side effects. Budesonide

Pacific University EBM Capstone Project2013