Latest & greatest articles for budesonide

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Top results for budesonide

1. Budesonide (Jorveza) - to treat adults with eosinophilic oesophagitis

is linear over the tested dose range from 1 mg to 4 mg in single-dose. The overall results of the study, in comparison to the used reference formulation of budesonide (Budenofalk) capsules are shown in the following table: Table 7 Budesonide plasma pharmacokinetic parameters after single dose administration as orodispersible tablets (1 mg (SD1), 2 mg (SD2), 4 mg (SD3)) or as oral capsule (3 mg (R)) in healthy subjects The main result of the study has shown that the relative bioavailability of the new (...) Budesonide (Jorveza) - to treat adults with eosinophilic oesophagitis 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 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 09 November 2017 EMA/774645/2017 Assessment report Jorveza International non-proprietary name: budesonide

2018 European Medicines Agency - EPARs

2. Budesonide

aspiration: randomized controlled trial. A total of 78 neonates were included in the study. After randomization, intervention group received nebulization with Budesonide (0.5 mg dissolved 2014 17. Pulmicort Respules( Budesonide Inhalation Suspension) vs Singulair, Children Pulmicort Respules( Budesonide Inhalation Suspension) vs Singulair, Children - Full Text View - ClinicalTrials.gov A service of the U.S. National Institutes of Health Example: "Heart attack" AND "Los Angeles" Search for studies: Study (...) Record Detail Pulmicort Respules( Budesonide Inhalation Suspension) vs Singulair, Children This study has been completed. Sponsor: AstraZeneca Information provided by: AstraZeneca (...) will receive 5mg strength SINGULAR. Asthma Drug: Budesonide inhalation suspension Drug: Montelukast Sodium Phase 4 Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Official Title: An Evaluation of the Effectiveness

2018 Trip Latest and Greatest

3. 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

2014 European Medicines Agency - EPARs

4. Can we use the combination formoterol-budesonide in teenagers with moderate or severe asthma?

Can we use the combination formoterol-budesonide in teenagers with moderate or severe asthma? Can we use the combination formoterol-budesonide in teenagers with moderate or severe asthma? - Evidencias en pediatría Searching, please wait Show menu Library Management You did not add any article to your library yet. | Search Evidence-Based decision making Evidence-Based decision making Show menu Library Management You did not add any article to your library yet. × User Password Log in × Reset (...) password If you need to reset your password please enter your email and click the Send button. You will receive an email to complete the process. Email Send × Library Management × March 2017. Volume 13. Number 1 Can we use the combination formoterol-budesonide in teenagers with moderate or severe asthma? Rating: 0 (0 Votes) Reviewers: , . | Newsletter Free Subscription Regularly recieve most recent articles by e-mail Subscribe × Newsletter subscription: Email Confirm email I accept the journal’s

2017 Evidencias en Pediatría

5. A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma

A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study (...) Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma (MANDALA) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated

2018 Clinical Trials

6. The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis

The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more (...) studies before adding more. The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01769898 Recruitment Status : Completed First Posted : January 17, 2013 Last Update Posted : March 11, 2015 Sponsor: The First

2013 Clinical Trials

7. 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

2014 European Medicines Agency - EPARs

8. Budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): a 52-week, open-label, multicentre, superiority, randomised controlled trial. (Abstract)

Budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): a 52-week, open-label, multicentre, superiority, randomised controlled trial. In adults with mild asthma, a combination of an inhaled corticosteroid with a fast-onset long-acting β-agonist (LABA) used as reliever monotherapy reduces severe exacerbations compared with short-acting β-agonist (SABA) reliever therapy. We investigated the efficacy (...) of combination budesonide-formoterol reliever therapy compared with maintenance budesonide plus as-needed terbutaline.We did a 52-week, open-label, parallel-group, multicentre, superiority, randomised controlled trial at 15 primary care or hospital-based clinical trials units and primary care practices in New Zealand. Participants were adults aged 18-75 years with a self-reported doctor's diagnosis of asthma who were using SABA for symptom relief with or without maintenance low to moderate doses of inhaled

2019 Lancet Controlled trial quality: predicted high

9. Budesonide facilitates weaning from mechanical ventilation in difficult-to-wean very severe COPD patients: Association with inflammatory mediators and cells. Full Text available with Trip Pro

Budesonide facilitates weaning from mechanical ventilation in difficult-to-wean very severe COPD patients: Association with inflammatory mediators and cells. Mechanical ventilatory support is life-saving therapy for patients with respiratory failure in intensive care units (ICU) but is linked to ventilator-associated pneumonia and other nosocomial infections. Interventions that improve the efficiency of weaning from mechanical ventilation may improve patient outcomes.To determine whether (...) inhaled budesonide decreases time-to-weaning in COPD stage 4 difficult-to-wean patients and reduces the release of pro-inflammatory cytokines in ICU patients.We recruited 55 difficult-to-wean COPD patients (Stage 4) within the ICU of the Masih Daneshvari Hospital. Subjects were randomly assigned to receive inhaled budesonide (0.5mg/day) or placebo (normal saline). Dynamic compliance and BAL cytokines were measured.Budesonide significantly reduced the number of days on MV (days-to-weaning=4.6±1.6days

2018 Journal of critical care Controlled trial quality: uncertain

10. A Randomized Controlled Trial of Budesonide Versus Acetazolamide for the Prevention of Acute Mountain Sickness (Abstract)

A Randomized Controlled Trial of Budesonide Versus Acetazolamide for the Prevention of Acute Mountain Sickness Inhaled budesonide has been suggested as a novel prevention for acute mountain sickness. However, efficacy has not been compared with the standard acute mountain sickness prevention medication acetazolamide.This double-blind, randomized, placebo-controlled trial compared inhaled budesonide versus oral acetazolamide versus placebo, starting the morning of ascent from 1240 m (4100 ft (...) ) to 3810 m (12,570 ft) over 4 hours. The primary outcome was acute mountain sickness incidence (headache and Lake Louise Questionnaire ≥3 and another symptom).A total of 103 participants were enrolled and completed the study; 33 (32%) received budesonide, 35 (34%) acetazolamide, and 35 (34%) placebo. Demographics were not different between the groups (P > .09). Acute mountain sickness prevalence was 73%, with severe acute mountain sickness of 47%. Fewer participants in the acetazolamide group (n = 15

2017 EvidenceUpdates

11. Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. (Abstract)

Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. In patients with mild asthma, as-needed use of an inhaled glucocorticoid plus a fast-acting β2-agonist may be an alternative to conventional treatment strategies.We conducted a 52-week, double-blind trial involving patients 12 years of age or older with mild asthma. Patients were randomly assigned to one of three regimens: twice-daily placebo plus terbutaline (0.5 mg) used as needed (terbutaline group), twice-daily placebo plus (...) budesonide-formoterol (200 μg of budesonide and 6 μg of formoterol) used as needed (budesonide-formoterol group), or twice-daily budesonide (200 μg) plus terbutaline used as needed (budesonide maintenance group). The primary objective was to investigate the superiority of as-needed budesonide-formoterol to as-needed terbutaline with regard to electronically recorded weeks with well-controlled asthma.A total of 3849 patients underwent randomization, and 3836 (1277 in the terbutaline group, 1277

2018 NEJM Controlled trial quality: predicted high

12. A prospective open clinical trial of a proton pump inhibitor, elimination diet and/or budesonide for eosinophilic oesophagitis. (Abstract)

A prospective open clinical trial of a proton pump inhibitor, elimination diet and/or budesonide for eosinophilic oesophagitis. Elimination diets and high-dose proton pump inhibitors (PPI) are advocated as first-line treatments in patients with eosinophilic oesophagitis (EoE).To record the treatment outcome for patients with EoE prospectively managed according to a clinical algorithm.Patients with oesophageal eosinophilia commenced esomeprazole 40 mg twice daily for 8 weeks. Those (...) in histological remission were re-classified as PPI-responsive oesophageal eosinophilia. Nonresponders were offered the 6-food elimination diet with a PPI, or topical budesonide monotherapy (1 mg orally twice daily as an aqueous gel). Once disease control was achieved remission was reassessed at 3 months (all modalities) and an additional 6 months (diet group).Of 107 patients who completed 8 weeks of PPI, 25 (23%) were PPI-responsive. 56 of 81 (69%) of patients with EoE chose the elimination diet with PPI. 29

2016 Alimentary Pharmacology & Therapeutics

13. A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD) A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (...) (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03478683 Recruitment Status : Active, not recruiting First Posted : March 27, 2018 Last Update Posted : February 22, 2019 Sponsor: GlaxoSmithKline

2018 Clinical Trials

14. The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials. Full Text available with Trip Pro

The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given 'as needed' in mild asthma: study protocols for two randomised controlled trials. In many patients with mild asthma, the low frequency of symptoms and the episodic nature of exacerbations make adherence to regular maintenance treatment difficult. This often leads to over-reliance on short-acting β2-agonist (SABA) reliever medication and under-treatment of the underlying inflammation (...) , with poor control of asthma symptoms and increased risk of exacerbations. The use of budesonide/formoterol 'as needed' in response to symptoms may represent an alternative treatment option for patients with mild asthma.The SYmbicort Given as needed in Mild Asthma (SYGMA) programme consists of two 52-week, double-blind, randomised, multicentre, parallel-group, phase 3 trials of patients aged 12 years and older with a clinical diagnosis of asthma for at least 6 months, who would qualify for treatment

2017 Trials

15. A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) - Full Text View - ClinicalTrials.gov Hide glossary (...) Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease

2015 Clinical Trials

16. Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial Full Text available with Trip Pro

Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off-label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT (...) had achieved remission. Six-week and 12-week BOT administration were safe and well tolerated; 5% of patients who received BOT developed symptomatic, mild candida, which was easily treated with an oral antifungal agent.In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. Eudra-CT number 2014-001485-99; ClinicalTrials.gov ID NCT02434029.Copyright © 2019 AGA Institute

2019 EvidenceUpdates

17. Surfactant plus budesonide decreases lung and systemic inflammation in mechanically ventilated preterm sheep. (Abstract)

Surfactant plus budesonide decreases lung and systemic inflammation in mechanically ventilated preterm sheep. Mechanical ventilation with normal tidal volumes (VT) 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: 1) surfactant (200 mg/kg) or 2) surfactant mixed with budesonide (0.25 mg/kg) before mechanical ventilation with VT of 7-8 ml/kg for 2, 6, or 24 h (n = 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

2019 American journal of physiology. Lung cellular and molecular physiology Controlled trial quality: uncertain

18. Comparison of the efficacy and mechanisms of intranasal budesonide, montelukast, and their combination in treatment of patients with seasonal allergic rhinitis. (Abstract)

Comparison of the efficacy and mechanisms of intranasal budesonide, montelukast, and their combination in treatment of patients with seasonal allergic rhinitis. Although intranasal steroids and anti-cysteinyl-leukotriene-receptor antagonists are efficacious in the treatment of seasonal allergic rhinitis (SAR), combinations of these agents have not unequivocally been demonstrated to be superior to the individual drugs. We aimed to compare the efficacy and potential mechanisms of budesonide nasal (...) spray (BD), oral montelukast (MNT), and combination therapy comprising a half-dose of budesonide plus montelukast (hBD+MNT) in SAR patients.We performed a single-center, randomized, open-label study in SAR subjects (n = 100). Participants were randomized to receive BD (256 μg), MNT (10 mg), or hBD (128 μg)+MNT for 14 days. Symptom severity scores, nasal cavity volume (NCV), fraction of exhaled nitric oxide (FeNO), eosinophil cationic protein (ECP), histamine and cysteinyl-leukotrienes (CysLTs

2018 International forum of allergy & rhinology Controlled trial quality: uncertain

19. Retrospective Comparison of Fluticasone Propionate and Oral Viscous Budesonide in Children with Eosinophilic Esophagitis. (Abstract)

Retrospective Comparison of Fluticasone Propionate and Oral Viscous Budesonide in Children with Eosinophilic Esophagitis. Eosinophilic esophagitis (EoE) is treated with dietary modification and/or pharmacologic management with swallowed topical steroids. Swallowed fluticasone propionate (FP) and oral viscous budesonide (OVB) have proven to be effective in resolving symptoms and reversing histologic changes in children and adults with EoE. There are minimal comparative studies between the 2

2017 Journal of Pediatric Gastroenterology and Nutrition

20. Adrenal suppression in children treated with swallowed fluticasone and oral viscous budesonide for eosinophilic esophagitis Full Text available with Trip Pro

Adrenal suppression in children treated with swallowed fluticasone and oral viscous budesonide for eosinophilic esophagitis Adrenal suppression (AS), a glucocorticoid (GC) side effect associated with significant morbidity, is well described related to inhaled corticosteroid therapy for asthma. Swallowed topical glucocorticoid therapy is the main pharmacotherapy treatment for eosinophilic esophagitis (EoE) and therefore children with EoE are potentially at increased risk of AS.In (...) this prospective cohort study, we included children and youth <18 years diagnosed with EoE and treated with swallowed fluticasone or oral viscous budesonide for more than 1 month. First morning cortisol and low dose adrenocorticotropic hormone stimulation test (LDST) were performed 2 weeks following GC discontinuation. AS was defined as an abnormal LDST result (cortisol peak <500 nmol/L). We determined the prevalence and duration of AS related to swallowed topical GC therapy in EoE by LDST, as well

2016 Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology