Latest & greatest articles for fluticasone

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Top results for fluticasone

21. Aerivio Spiromax (salmeterol xinafoate / fluticasone propionate) - Asthma or Pulmonary Disease, Chronic Obstructive

Aerivio Spiromax (salmeterol xinafoate / fluticasone propionate) - Asthma or Pulmonary Disease, Chronic Obstructive 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, 2016. Reproduction is authorised provided the source is acknowledged. 23 June 2016 EMA/486136/2016 Committee for Medicinal Products (...) for Human Use (CHMP) Assessment report Aerivio Spiromax International non-proprietary name: salmeterol / fluticasone propionate Procedure No. EMEA/H/C/002752/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/486136/2016 Page 2/50 Table of contents 1. Background information on the procedure 5 1.1. Submission of the dossier 5 1.2. Steps taken for the assessment of the product 7 2. Scientific discussion 8 2.1

2016 European Medicines Agency - EPARs

22. Airexar Spiromax (salmeterol / fluticasone propionate) - Asthma or Pulmonary Disease, Chronic Obstructive

Airexar Spiromax (salmeterol / fluticasone propionate) - Asthma or Pulmonary Disease, Chronic Obstructive 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 23 June 2016 EMA/486131/2016 Committee for Medicinal Products for Human Use (CHMP) Assessment report Airexar Spiromax International non-proprietary name: salmeterol (...) / fluticasone propionate Procedure No. EMEA/H/C/004267/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/486131/2016 Page 2/53 Table of contents 1. Background information on the procedure 6 1.1. Submission of the dossier 6 1.2. Steps taken for the assessment of the product 8 2. Scientific discussion 9 2.1. Introduction 9 2.2. Quality aspects 11 2.2.1. Introduction 11 2.2.2. Active substance 12 Fluticasone propionate

2016 European Medicines Agency - EPARs

23. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. (Full text)

Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. Most guidelines recommend either a long-acting beta-agonist (LABA) plus an inhaled glucocorticoid or a long-acting muscarinic antagonist (LAMA) as the first-choice treatment for patients with chronic obstructive pulmonary disease (COPD) who have a high risk of exacerbations. The role of treatment with a LABA-LAMA regimen in these patients is unclear.We conducted a 52-week, randomized, double-blind, double-dummy, noninferiority (...) trial. Patients who had COPD with a history of at least one exacerbation during the previous year were randomly assigned to receive, by inhalation, either the LABA indacaterol (110 μg) plus the LAMA glycopyrronium (50 μg) once daily or the LABA salmeterol (50 μg) plus the inhaled glucocorticoid fluticasone (500 μg) twice daily. The primary outcome was the annual rate of all COPD exacerbations.A total of 1680 patients were assigned to the indacaterol-glycopyrronium group, and 1682 to the salmeterol

2016 NEJM PubMed

24. Safety of Fluticasone plus Salmeterol in Asthma - Reassuring Data, but No Final Answer. (PubMed)

Safety of Fluticasone plus Salmeterol in Asthma - Reassuring Data, but No Final Answer. 26946980 2016 05 25 2018 12 02 1533-4406 374 19 2016 May 12 The New England journal of medicine N. Engl. J. Med. Safety of Fluticasone plus Salmeterol in Asthma--Reassuring Data, but No Final Answer. 1887-8 10.1056/NEJMe1601040 Martinez Fernando D FD From the Arizona Respiratory Center, University of Arizona, Tucson. eng Editorial Comment 2016 03 06 United States N Engl J Med 0255562 0028-4793 0 (...) Bronchodilator Agents 0 Fluticasone-Salmeterol Drug Combination CUT2W21N7U Fluticasone AIM IM N Engl J Med. 2016 May 12;374(19):1822-30 26949137 Asthma drug therapy Bronchodilator Agents therapeutic use Female Fluticasone therapeutic use Fluticasone-Salmeterol Drug Combination therapeutic use Humans Male 2016 3 8 6 0 2016 3 8 6 0 2016 5 26 6 0 ppublish 26946980 10.1056/NEJMe1601040

2016 NEJM

25. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. (Full text)

Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. The safe and appropriate use of long-acting beta-agonists (LABAs) for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate.In this multicenter (...) , randomized, double-blind trial, adolescent and adult patients (age, ≥12 years) with persistent asthma were assigned to receive either fluticasone with salmeterol or fluticasone alone for 26 weeks. All the patients had a history of a severe asthma exacerbation in the year before randomization but not during the previous month. Patients were excluded from the trial if they had a history of life-threatening or unstable asthma. The primary safety end point was the first serious asthma-related event (death

2016 NEJM PubMed

26. Intranasal Fluticasone Propionate Observational Cohort Safety Studies: Reviewing Evidence from Databases on Two Continents (Full text)

Intranasal Fluticasone Propionate Observational Cohort Safety Studies: Reviewing Evidence from Databases on Two Continents Our objective was to highlight the importance of database selection in observational research and to determine the incidence of corticosteroid-related events in patients exposed to fluticasone propionate intranasal spray (FPNS) compared with other intranasal steroids (INS).After a feasibility study using an electronic medical record database in the UK (1990-2002

2016 Drugs - real world outcomes PubMed

27. Fluticasone Furoate and Vilanterol (as trifenatate) (Breo Ellipta)

Fluticasone Furoate and Vilanterol (as trifenatate) (Breo Ellipta) Fluticasone Furoate and Vilanterol (as trifenatate) | CADTH.ca Find the information you need Fluticasone Furoate and Vilanterol (as trifenatate) Fluticasone Furoate and Vilanterol (as trifenatate) Last Updated: January 15, 2018 Result type: Reports Project Number: SR0442-000 Product Line: Generic Name: Fluticasone Furoate and Vilanterol (as trifenatate) Brand Name: Breo Ellipta Manufacturer: GlaxoSmithKline Inc. Indications

2015 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

28. Fluticasone Furoate and Vilanterol (as trifenatate) (Breo Ellipta)

Fluticasone Furoate and Vilanterol (as trifenatate) (Breo Ellipta) Fluticasone Furoate and Vilanterol (as trifenatate) | CADTH.ca Find the information you need Fluticasone Furoate and Vilanterol (as trifenatate) Fluticasone Furoate and Vilanterol (as trifenatate) Last Updated: January 15, 2018 Result type: Reports Project Number: SR0442-000 Product Line: Generic Name: Fluticasone Furoate and Vilanterol (as trifenatate) Brand Name: Breo Ellipta Manufacturer: GlaxoSmithKline Inc. Indications

2015 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

29. Fluticasone furoate (TBC)

Fluticasone furoate (TBC) Fluticasone furoate | CADTH.ca Find the information you need Fluticasone furoate Fluticasone furoate Last Updated: May 4, 2015 Result type: Reports Project Number: SR0439-000 Product Line: Generic Name: Fluticasone furoate Brand Name: Arnuity Ellipta Manufacturer: GlaxoSmithKline Inc. Indications: Asthma Submission Type: New Project Status: Complete Date Recommendation Issued: December 17, 2015 Recommendation Type: List with criteria/condition Tags asthma Files Follow

2015 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

30. Effect of fluticasone propionate on virus-induced airways inflammation and anti-viral immune responses in mice. (PubMed)

Effect of fluticasone propionate on virus-induced airways inflammation and anti-viral immune responses in mice. Inhaled corticosteroids are commonly used in the treatment of asthma and chronic obstructive pulmonary disease, but their effects on viral loads and anti-viral responses are poorly characterised. The aim of this study was to assess effects of inhaled fluticasone propionate on rhinovirus infection in vivo, in a mouse model. We tested the hypothesis that this treatment would reduce (...) virus-induced airways inflammation but that the effect would be confounded by interference with anti-viral immune responses, leading to delayed viral clearance.C57BL/6 mice were intranasally dosed with fluticasone propionate (1 mg/kg) or vehicle (dimethyl sulfoxide, control), 1 h before infection with rhinovirus 1B. We assessed bronchoalveolar lavage (BAL) inflammatory cell numbers, and measured gene expression, protein production of innate mediators, or both by quantitative RT-PCR or ELISA. We

2015 Lancet

31. Fluticasone furoate/vilanterol (as trifenatate) (Relvar® Ellipta®)

Fluticasone furoate/vilanterol (as trifenatate) (Relvar® Ellipta®) Fluticasone furoate/vilanterol (as trifenatate) (Relvar® Ellipta®) Fluticasone furoate/vilanterol (as trifenatate) (Relvar® Ellipta®) All Wales Medicines Strategy Group (AWMSG) Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation All Wales Medicines Strategy Group (AWMSG). Fluticasone furoate (...) /vilanterol (as trifenatate) (Relvar® Ellipta®) Penarth: All Wales Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No. 2014. 2014 Authors' conclusions Fluticasone furoate/vilanterol (Relvar® Ellipta®) is recommended as an option for use within NHS Wales for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2

2015 Health Technology Assessment (HTA) Database.

32. Fluticasone furoate/vilanterol (as trifenatate) (Relvar® Ellipta®)

Fluticasone furoate/vilanterol (as trifenatate) (Relvar® Ellipta®) Fluticasone furoate/vilanterol (as trifenatate) (Relvar® Ellipta®) Fluticasone furoate/vilanterol (as trifenatate) (Relvar® Ellipta®) All Wales Medicines Strategy Group (AWMSG) Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation All Wales Medicines Strategy Group (AWMSG). Fluticasone furoate (...) /vilanterol (as trifenatate) (Relvar® Ellipta®) Penarth: All Wales Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat Assessment Report Advice No. 1014. 2014 Authors' conclusions Fluticasone furoate/vilanterol (as trifenatate) (Relvar® Ellipta®) is recommended as an option for use within NHS Wales for the symptomatic treatment of adults with chronic obstructive pulmonary disease with a FEV1< 70% predicted normal (post-bronchodilator

2015 Health Technology Assessment (HTA) Database.

33. Azelastine hydrochloride and fluticasone propionate (Dymista nasal spray suspension) - moderate to severe seasonal and perennial allergic rhinitis

Azelastine hydrochloride and fluticasone propionate (Dymista nasal spray suspension) - moderate to severe seasonal and perennial allergic rhinitis HAS - Medical, Economic and Public Health Assessment Division 1/17 Opinion 2 The legally binding text is the original French version T TR RA AN NS SP PA AR RE EN NC CY Y C CO OM MM MI IT TT TE EE E Opinion 5 February 2014 DYMISTA 137 µg/50 µg, nasal spray suspension Bottle with 23 g suspension of 25 ml or around 120 doses (CIP: 34009 275 631 1 9 (...) ) Applicant: MEDA PHARMA INN Azelastine hydrochloride, fluticasone propionate. ATC Code (2013): R01AD58 (nasal corticosteroid, combinations) Reason for the request Inclusion Lists concerned National Health Insurance (French Social Security Code L.162-17) Hospital use (French Public Health Code L.5123-2) Indications concerned "Relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient

2014 Haute Autorite de sante

34. Fluticasone furoate/vilanterol (as trifenatate) (Relvar Ellipta) - for the regular treatment of asthma

Fluticasone furoate/vilanterol (as trifenatate) (Relvar Ellipta) - for the regular treatment of asthma Final Appraisal Recommendation Advice No: 2014 – July 2014 Fluticasone furoate/vilanterol (as trifenatate) (Relvar ® Ellipta ® ? ) 92/22 micrograms and 184/22 micrograms inhalation powder Submission by GlaxoSmithKline In reaching the above recommendation AWMSG has taken account of the appraisal documentation prepared by the AWMSG Secretariat (reference number 1216), which includes the AWMSG (...) of AWMSG Fluticasone furoate/vilanterol (Relvar ® Ellipta ® ? ) is recommended as an option for use within NHS Wales for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: ? patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists. Statement of use: No part of this recommendation may be reproduced

2014 All Wales Medicines Strategy Group

35. Fluticasone furoate/vilanterol (as trifenatate) (Relvar Ellipta) for chronic obstructive pulmonary disease

Fluticasone furoate/vilanterol (as trifenatate) (Relvar Ellipta) for chronic obstructive pulmonary disease Final Appraisal Recommendation Advice No: 1014 – May 2014 Fluticasone furoate/vilanterol (as trifenatate) (Relvar ® Ellipta ® ? ) 92 micrograms/22 micrograms inhalation powder Submission by GlaxoSmithKline Additional note: ? Fluticasone furoate/vilanterol (as trifenatate) (Relvar ® Ellipta ® ? ) should be used in line with NICE Clinical Guideline on chronic obstructive pulmonary disease (...) by Welsh Government and will be considered for review every three years. Marketing authorisation holder on first issue: GlaxoSmithKline Date of first issue May 2014 Last reviewed May 2017 Statement of use: No part of this recommendation may be reproduced without the whole recommendation being quoted in full and cited as: All Wales Medicines Strategy Group. Final Appraisal Recommendation – 1534: fluticasone furoate/vilanterol (as trifenatate) 92 micrograms/22 micrograms inhalation powder May 2014

2014 All Wales Medicines Strategy Group

36. Asthma: fluticasone furoate/vilanterol (Relvar Ellipta) combination inhaler

Asthma: fluticasone furoate/vilanterol (Relvar Ellipta) combination inhaler Asthma: fluticasone furoate/vilanterol (Relvar Asthma: fluticasone furoate/vilanterol (Relvar Ellipta) combination inhaler Ellipta) combination inhaler Evidence summary Published: 3 March 2014 nice.org.uk/guidance/esnm34 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 March 2014. See summaries of product characteristics (SPCs), British national (...) formulary (BNF), BNF for children (BNFc) or the MHRA or NICE websites for up-to-date information. Summary Relvar Ellipta is a combination inhaler containing 2 active ingredients not previously available for the treatment of asthma: fluticasone furoate (an inhaled corticosteroid [ICS]) and vilanterol (a long- acting beta-2 agonist [LABA]). There are no published studies that compare fluticasone furoate/ vilanterol with a currently available ICS/LABA combination inhaler or currently available ICS

2014 National Institute for Health and Clinical Excellence - Advice

37. Azelastine - HCl and fluticasone propionate

Azelastine - HCl and fluticasone propionate Azelastine - HCl and fluticasone propionate Azelastine - HCl and fluticasone propionate CADTH Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH. Azelastine - HCl and fluticasone propionate. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). Common Drug Review. 2014 Authors (...) ' conclusions The Canadian Drug Expert Committee (CDEC) recommends that azelastine hydrochloride/ fluticasone propionate (AZE/FP) not be listed for the symptomatic treatment of moderate-to-severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults and adolescents aged 12 years and older for whom monotherapy with either antihistamines or intranasal corticosteroids is not considered sufficient. Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Humans; Rhinitis

2014 Health Technology Assessment (HTA) Database.

38. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone (Full text)

Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone Combination therapy with an inhaled corticosteroid (ICS) and long-acting β2 agonist (LABA) is recommended for patients with asthma symptomatic on ICS alone. However, there is ongoing debate regarding the risk-benefit ratio of using LABA in asthma.To evaluate the effect of the addition of a novel LABA, vilanterol (VI), to a once-daily ICS, fluticasone furoate (FF), on the risk of severe

2014 EvidenceUpdates PubMed

39. Clinical and cost effectiveness of switching asthma patients from fluticasone-salmeterol to extra-fine particle beclometasone-formoterol: a retrospective matched observational study of real-world patients (Full text)

Clinical and cost effectiveness of switching asthma patients from fluticasone-salmeterol to extra-fine particle beclometasone-formoterol: a retrospective matched observational study of real-world patients Clinical and cost effectiveness of switching asthma patients from fluticasone-salmeterol to extra-fine particle beclometasone-formoterol: a retrospective matched observational study of real-world patients Clinical and cost effectiveness of switching asthma patients from fluticasone-salmeterol (...) and the conclusions drawn. CRD summary The study evaluated the cost-effectiveness of switching typical asthma patients to extra-fine particle beclometasone-formoterol (efBDP-FOR) treatment. The authors concluded that switching asthma patients from fluticasone propionate and salmeterol (FP-SAL) to efBDP-FOR at an equivalent or lower dose was both less costly and more effective. The analysis and results appear to support the authors' conclusions but some uncertainty remains due to the study design and cost

2014 NHS Economic Evaluation Database. PubMed

40. Fluticasone furoate vilanterol (Breo Ellipta ? GlaxoSmithKline) indication: chronic obstructive pulmonary disease

Fluticasone furoate vilanterol (Breo Ellipta ? GlaxoSmithKline) indication: chronic obstructive pulmonary disease Fluticasone furoate /vilanterol (Breo Ellipta — GlaxoSmithKline) indication: chronic obstructive pulmonary disease Fluticasone furoate /vilanterol (Breo Ellipta — GlaxoSmithKline) indication: chronic obstructive pulmonary disease CADTH Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality (...) of this assessment has been made for the HTA database. Citation CADTH. Fluticasone furoate /vilanterol (Breo Ellipta — GlaxoSmithKline) indication: chronic obstructive pulmonary disease. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDEC Final Recommendation; SR0358. 2014 Authors' conclusions The Canadian Drug Expert Committee (CDEC) recommends that fluticasone furoate/vilanterol (FF/V) be listed for the long-term, once-daily maintenance treatment of airflow obstruction in patients

2014 Health Technology Assessment (HTA) Database.