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Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the beta2 agonist vilanterol administered once daily for 52 weeks in patients >=12 years old with asthma: a randomised trial The inhaled corticosteroid fluticasone furoate (FF) in combination with the long-acting β2 agonist vilanterol (VI) is in development for asthma and chronic obstructive pulmonary disease.To assess the safety and tolerability of FF/VI over 52 weeks in patients (...) with asthma.Patients (aged ≥12 years; on inhaled corticosteroid) were randomised (2:2:1) to FF/VI 100/25 µg or FF/VI 200/25 µg once daily in the evening, or fluticasone propionate (FP) 500 µg twice daily. Safety evaluations included adverse events (AEs), non-fasting glucose, potassium, 24-h urinary cortisol excretion, ophthalmic assessments, heart rate and pulse rate.On-treatment AEs were similar across groups (FF/VI 66-69%; 73% FP). Oral candidiasis/oropharyngeal candidiasis was more common with FF/VI (6-7%) than
Randomized Controlled Trial Comparing Aerosolized Swallowed Fluticasone to Esomeprazole for Esophageal Eosinophilia Patients with clinical symptoms of esophageal dysfunction and dense eosinophilic infiltration of the esophageal mucosa are suspected to have eosinophilic esophagitis (EoE). Topical steroids are often used as first-line therapy for EoE, although some patients respond clinically to proton pump inhibitors (PPIs). The purpose of this study was to compare the histological and clinical (...) response of patients with esophageal eosinophilia treated with aerosolized swallowed fluticasone propionate vs. esomeprazole.This prospective single-blinded randomized controlled trial enrolled newly diagnosed patients with suspected EoE, defined as having clinical symptoms related to esophageal dysfunction with at least 15 eosinophils/high power field (hpf). Patients underwent 24-h pH/impedance monitoring to establish gastroesophageal reflux disease (GERD). Patients were stratified by the presence
Chronic obstructive pulmonary disease: fluticasone furoate plus vilanterol Chronic obstructiv Chronic obstructive pulmonary disease: e pulmonary disease: fluticasone furoate plus vilanterol fluticasone furoate plus vilanterol Evidence summary Published: 18 June 2013 nice.org.uk/guidance/esnm21 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 2013. See summaries of product characteristics (SPCs), British national (...) formulary (BNF) or the MHRA or NICE websites for up- to-date information. Summary Fluticasone furoate/vilanterol (Relvar Ellipta) is a once-daily corticosteroid and long-acting beta 2 agonist combination inhaler, which has been submitted for a marketing authorisation for the symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) and an exacerbation history despite regular bronchodilator therapy. There are currently no published studies comparing fluticasone furoate/vilanterol
Cost-effectiveness and cost-utility of beclomethasone/formoterol versus fluticasone propionate/salmeterol in patients with moderate to severe asthma Cost-effectiveness and cost-utility of beclomethasone/formoterol versus fluticasone propionate/salmeterol in patients with moderate to severe asthma Cost-effectiveness and cost-utility of beclomethasone/formoterol versus fluticasone propionate/salmeterol in patients with moderate to severe asthma Gerzeli S, Rognoni C, Quaglini S, Cavallo MC (...) , Cremonesi G, Papi A Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary The objective was to assess the cost-effectiveness of beclomethasone with formoterol versus fluticasone propionate with salmeterol, for patients with moderate-to-severe
Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) - For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema Drug Approval Package: Brand Name (Generic Name) NDA # Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Ellipta (fluticasone furoate and vilanterol trifenatate) Inhalation Powder Company: GlaxoSmithKline
Asthma: fluticasone/formoterol (Flutiform) combination inhaler Asthma: fluticasone/formoterol (Flutiform) Asthma: fluticasone/formoterol (Flutiform) combination inhaler combination inhaler Evidence summary Published: 12 October 2012 nice.org.uk/guidance/esnm3 pathways Ov Overview erview Key points from the evidence The content of this evidence summary was up-to-date in October 2012. 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. Fluticasone/formoterol (Flutiform) is a combination inhaler containing an inhaled corticosteroid (ICS) and a long-acting beta-2 agonist (LABA). It was launched in the UK in September 2012 and is indicated for regular treatment of asthma when a combination inhaler is appropriate: for people whose asthma is not adequately controlled on an ICS and an 'as required' inhaled short-acting beta-2 agonist, or for people whose asthma is adequately controlled
Dymista (azelastine hydrochloride and fluticasone proprionate) Nasal Spray Drug Approval Package: Dymista (azelastine hydrochloride and fluticasone proprionate) NDA #202236 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Dymista (azelastine hydrochloride and fluticasone proprionate) Nasal Spray, 137 mcg/50mcg Company: Meda Pharmaceuticals, Inc. Application No.: 202236 Approval Date: 05/01/2012 Persons with disabilities having problems accessing the PDF
Fluticasone furoate and Vilanterol (Breo Ellipta) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204275Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 204275 Priority or Standard Standard Submit Date(s) July 11, 2012 Received Date(s) July 12, 2012 PDUFA Goal Date May 12, 2012 Division / Office ODEII/DPARP Reviewer Name(s) Sofia Chaudhry, MD Review Completion Date March 18, 2013 Established Name Fluticasone furoate and Vilanterol (Proposed (...) ) Trade Name Breo Ellipta Therapeutic Class ICS/LABA Applicant GlaxoSmithKline Formulation(s) Orally inhaled Dosing Regimen Once daily Indication(s) 1) Maintenance treatment of airflow obstruction 2) Reduction in exacerbation Intended Population(s) COPD Template Version: March 6, 2009 Reference ID: 3277679Clinical Review Sofia Chaudhry, MD NDA 204275 Breo Ellipta (fluticasone furoate and vilanterol) 2 Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT 9 1.1 Recommendation on Regulatory Action
Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials This analysis was designed to provide a comparison between budesonide/formoterol and salmeterol/fluticasone for the relative incidence of pneumonia adverse events, pneumonia serious adverse events and pneumonia-related mortality in patients being treated for chronic obstructive pulmonary disease.An initial literature search revealed (...) no suitable head-to-head trials between budesonide/formoterol and salmeterol/fluticasone and therefore a systematic review was conducted to find randomised controlled trials providing data for input into an adjusted indirect comparison of the two combination treatments using placebo as a common comparator. The Bucher adjusted indirect comparison method was used to calculate odds ratios and 95% confidence intervals.Eight salmeterol/fluticasone trials and four budesonide/formoterol trials were identified
Fluticasone furoate versus fluticasone propionate for seasonal allergic rhinitis: a review of the clinical and cost-effectiveness Fluticasone furoate versus fluticasone propionate for seasonal allergic rhinitis: a review of the clinical and cost-effectiveness Fluticasone furoate versus fluticasone propionate for seasonal allergic rhinitis: a review of the clinical and cost-effectiveness Canadian Agency for Drugs and Technologies in Health 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 Canadian Agency for Drugs and Technologies in Health. Fluticasone furoate versus fluticasone propionate for seasonal allergic rhinitis: a review of the clinical and cost-effectiveness. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). 2011 Authors' conclusions Two randomized controlled studies showed similar efficacy between
Oxymetazoline adds to the effectiveness of fluticasone furoate in the treatment of perennial allergic rhinitis In clinical trials, only about 60% of subjects report an excellent response to intranasal steroids, suggesting a need to add therapies to intranasal steroids to provide additional efficacy.To determine whether the combination of fluticasone furoate and oxymetazoline is more efficacious than either agent alone, and to determine whether rhinitis medicamentosa develops after treatment.We (...) performed a double-blind, double-dummy, randomized, placebo-controlled parallel study. Sixty patients with perennial allergy were randomized to 4 weeks of once-a-night treatment with fluticasone furoate, oxymetazoline hydrochloride, the combination, or placebo. They were monitored during treatment and for 2 weeks posttreatment.The total nasal symptom score over the 4 weeks of treatment was lower with the combination (median, 143; range, 30-316) compared with treatment with placebo (262; 116-358
Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control Patients with mild persistent asthma constitute about 70% of the asthma population; thus, it is important to know which first-line treatment is best for the management of mild asthma. We compared benefits of first-line treatment with ciclesonide and a combination of fluticasone and salmeterol in patients with mild asthma.Patients aged 12 to 75 years (...) with mild persistent asthma were enrolled in a randomized, double-blind, placebo-controlled study. After run-in, patients were randomized to ciclesonide 160 μg once daily (CIC160), fluticasone propionate/salmeterol 100/50 μg bid (FP200/S100), or placebo for 52 weeks. The primary variable was time to first severe asthma exacerbation; the coprimary variable was the percentage of poorly controlled asthma days. Patients recorded asthma symptoms and salbutamol use in electronic diaries and completed
Comparative efficacy of indacaterol 150mug and 300mug versus fixed-dose combinations of formoterol + budesonide or salmeterol + fluticasone for the treatment of chronic obstructive pulmonary disease: a network meta-analysis Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.
Comparative cost-effectiveness of a fluticasone-propionate/salmeterol combination versus anticholinergics as initial maintenance therapy for chronic obstructive pulmonary disease Comparative cost-effectiveness of a fluticasone-propionate/salmeterol combination versus anticholinergics as initial maintenance therapy for chronic obstructive pulmonary disease Comparative cost-effectiveness of a fluticasone-propionate/salmeterol combination versus anticholinergics as initial maintenance therapy (...) for chronic obstructive pulmonary disease Dalal AA, Roberts MH, Petersen HV, Blanchette CM, Mapel DW Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study assessed the cost-effectiveness of initial maintenance therapy with fluticasone
Combination therapy salmeterol/fluticasone versus doubling dose of fluticasone in children with asthma For children with symptomatic asthma despite low to moderate doses of inhaled corticosteroids, evidence is still lacking whether to add a long-acting bronchodilator or to increase the dose of inhaled corticosteroids.To evaluate whether salmeterol/fluticasone propionate (SFP), 50/100 μg twice a day, is noninferior regarding symptom control compared with fluticasone propionate (FP), 200 μg twice
Inhaled fluticasone propionate reduces postoperative sore throat, cough, and hoarseness Sore throat is a common complication after surgery. Postoperative cough and hoarseness can also be distressing to patients. We sought to determine the effect of an inhaler steroid on sore throat, cough, and hoarseness during the first 24 hours of the postoperative period.We enrolled 120 women with ASA physical status I or II and term singleton pregnancy who were scheduled for elective cesarean delivery under (...) general anesthesia. Patients were randomized into 2 groups: in the sitting position, group F patients received 500 μg inhaled fluticasone propionate via a spacer device during 2 deep inspirations, after arrival in the operating room, and group C had no treatment. The patients were interviewed by a blinded investigator for postoperative sore throat, cough, and hoarseness at 1 and 24 hours after surgery.There were no significant differences in age, height, weight, body mass index, duration of surgery
Fluticasone furoate nasal spray reduces the nasal-ocular reflex: a mechanism for the efficacy of topical steroids in controlling allergic eye symptoms Eye symptoms frequently occur in patients with allergic rhinitis and are among the most bothersome symptoms. Intranasal steroids have been shown to reduce ocular symptoms associated with allergic nasal symptoms, even though they do not reach the eye.To elucidate a mechanism to explain these observations.We performed a double-blind, placebo (...) -controlled, crossover experiment in 20 subjects with seasonal allergic rhinitis. Nasal antigen challenge was performed consecutively for 3 days after 1 week of treatment with either placebo or fluticasone furoate nasal spray (FFNS). Subjects recorded their nasal and ocular symptoms, and nasal secretions were quantified. Nasal scrapings to quantify eosinophils were obtained before each antigen challenge.Nasal challenge with antigen led to sneezing, a nasonasal, and a nasal-ocular reflex. Priming
Cost-effectiveness of salmeterol, fluticasone, and combination therapy for COPD Cost-effectiveness of salmeterol, fluticasone, and combination therapy for COPD Cost-effectiveness of salmeterol, fluticasone, and combination therapy for COPD Oba Y Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment (...) on the reliability of the study and the conclusions drawn. CRD summary The aim was to assess whether maintenance inhaled medication was cost-effective for patients with moderate-to-severe chronic obstructive pulmonary disease. The author concluded that, at willingness-to-pay thresholds over 52,800 US dollars per quality-adjusted life-year, combined fluticasone and salmeterol propionate therapy was most cost-effective, below this threshold no maintenance therapy, with bronchodilator use as needed, was most cost