The Experts below are selected from a list of 1557 Experts worldwide ranked by ideXlab platform
Loretta Jacques - One of the best experts on this subject based on the ideXlab platform.
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Effectiveness of Fluticasone Furoate/vilanterol versus Fluticasone propionate/salmeterol on asthma control in the Salford Lung Study.
The Journal of asthma : official journal of the Association for the Care of Asthma, 2018Co-Authors: Loretta Jacques, Nawar Diar Bakerly, John P. New, James Lay-flurrie, Henrik Svedsater, David LeatherAbstract:Objective: The Asthma Salford Lung Study demonstrated the effectiveness of initiating once-daily Fluticasone Furoate/vilanterol (FF/VI) versus continuing usual care in asthma patients in UK primary...
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Once-daily Fluticasone Furoate/vilanterol versus twice-daily Fluticasone propionate/salmeterol in patients with asthma well controlled on ICS/LABA
The Journal of asthma : official journal of the Association for the Care of Asthma, 2018Co-Authors: David I. Bernstein, Loretta Jacques, Leslie Andersen, Richard Forth, Louisa YatesAbstract:ABSTRACTObjective: We aimed to demonstrate non-inferiority of once-daily Fluticasone Furoate/vilanterol 100/25 µg (FF/VI) to twice-daily Fluticasone propionate/salmeterol 250/50 µg (FP/SAL) in adul...
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once daily Fluticasone Furoate vilanterol versus twice daily Fluticasone propionate salmeterol in patients with asthma well controlled on ics laba
Journal of Asthma, 2018Co-Authors: David I. Bernstein, Loretta Jacques, Leslie Andersen, Richard Forth, Louisa YatesAbstract:ABSTRACTObjective: We aimed to demonstrate non-inferiority of once-daily Fluticasone Furoate/vilanterol 100/25 µg (FF/VI) to twice-daily Fluticasone propionate/salmeterol 250/50 µg (FP/SAL) in adul...
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Integrated safety and efficacy analysis of once-daily Fluticasone Furoate for the treatment of asthma
Respiratory research, 2016Co-Authors: Paul M. O'byrne, Loretta Jacques, Caroline Goldfrad, Namhee Kwon, Michael Perrio, Louisa Yates, William W. BusseAbstract:Fluticasone Furoate is a once-daily inhaled corticosteroid. This report provides an overview of safety and efficacy data that support the use of once-daily Fluticasone Furoate 100 μg or 200 μg in adult and adolescent asthma patients. Fourteen clinical studies (six Phase II and eight Phase III) were conducted as part of the Fluticasone Furoate global clinical development programme in asthma. Safety data from 10 parallel-group, randomised, double-blind Phase II and III studies (including 3345 patients who received at least one dose of Fluticasone Furoate) were integrated to provide information on adverse events, withdrawals, laboratory assessments, vital signs and hypothalamic-pituitary-adrenal axis function. The efficacy of once-daily Fluticasone Furoate was evaluated in all included studies. Once-daily Fluticasone Furoate 100 μg and 200 μg safety profiles were consistent with those reported for other inhaled corticosteroids, and both doses consistently demonstrated efficacy versus placebo. In the integrated analysis, no dose-response relationship was observed for the overall incidence of adverse events and there were no significant effects of Fluticasone Furoate on hypothalamic-pituitary-adrenal axis function. Once-daily Fluticasone Furoate 100 μg and 200 μg had acceptable safety profiles and was efficacious in adult and adolescent patients with asthma. There was no evidence of cortisol suppression at studied doses. GSK (NCT01499446/FFA20001, NCT00398645/FFA106783, NCT00766090/112202, NCT00603746/FFA109684, NCT00603278/FFA109685, NCT00603382/FFA109687, NCT01436071/115283, NCT01436110/115285, NCT01159912/112059, NCT01431950/114496, NCT01165138/HZA106827, NCT01086384/106837, NCT01134042/HZA106829 and NCT01244984/1139879).
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Additional file 2: Figure S1. of Integrated safety and efficacy analysis of once-daily Fluticasone Furoate for the treatment of asthma
2016Co-Authors: Paul Oâbyrne, Loretta Jacques, Caroline Goldfrad, Namhee Kwon, Michael Perrio, Louisa Yates, William BusseAbstract:Plot of pneumonia incidence per 1000 patient-years and 95% CI by treatment group (integrated clinical studies). BD, twice daily; CI, confidence interval; FF, Fluticasone Furoate; FP, Fluticasone propionate; OD, once daily. (TIF 465 kb
Paul S. Thomas - One of the best experts on this subject based on the ideXlab platform.
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Phamacology of Fluticasone Furoate and vilanterol trifenatate combination therapy for asthma.
Expert review of respiratory medicine, 2016Co-Authors: Vicky Chang, Emma L. Gray, Paul S. ThomasAbstract:ABSTRACTIntroduction: Fluticasone Furoate (FF) is a novel inhaled corticosteroid (ICS). Vilanterol trifenate (VI) is a new inhaled, selective, long – acting β2 adrenergic agonist (LABA). It is now also marketed as a novel once daily combined ICS/LABA indicated for treatment of moderate and severe asthma.Areas covered: FF has a highly specific, fast association and slow dissociation from the glucocorticoid receptor, with a 24 hr duration of action. This, combined with a slow transport out of respiratory cells, creates a long tissue retention period. Vilanterol trifenate (VI) is a new inhaled, selective, long – acting β2 adrenergic agonist, also with a rapid onset of action with a maximal effect within 6 mins and prolonged lung retention with effects on lung function over 24 hours.Expert commentary: Multiple Phase I–III efficacy studies performed on FF and VI have shown an improvement in spirometry as well as symptom control in asthma. The development of once daily ICS/LABA combinations may potentially impr...
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Fluticasone Furoate and vilanterol trifenatate combination therapy for the treatment of asthma.
Expert review of respiratory medicine, 2016Co-Authors: Emma L. Gray, Vicky Chang, Paul S. ThomasAbstract:ABSTRACTIntroduction: Combination inhaled corticosteroids (ICS) and long acting β2-adrenergic agonists (LABA) are used in a stepwise fashion for patients whose asthma is not controlled by low dose ICS alone. Adherence is one of the main issues facing clinicians in the control of asthma symptoms with currently available combination inhalers requiring twice-daily (BD) inhalation. Fluticasone Furoate (FF) and vilanterol trifenatate (VI) both have prolonged retention in the lung with effects on lung function over 24-hours and as such the combination has been proposed for once-daily (OD) dosing.Areas covered: The stepwise pharmacologic approach to asthma management is addressed, followed by a detailed assessment of the literature pertaining to the efficacy, tolerability and safety of FF/VI combination therapy for the treatment of asthma.Expert commentary: Doses of 100/25µg and 200/25µg inhaled OD, have similar improvements in lung function, asthma control as well as rates of side effects to one of the currentl...
Ian M Adcock - One of the best experts on this subject based on the ideXlab platform.
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profile of Fluticasone Furoate vilanterol dry powder inhaler combination therapy as a potential treatment for copd
International Journal of Chronic Obstructive Pulmonary Disease, 2014Co-Authors: Gaetano Caramori, Kian Fan Chung, Ian M AdcockAbstract:Currently, there is no cure for chronic obstructive pulmonary disease (COPD). The limited efficacy of current therapies for COPD indicates a pressing need to develop new treatments to prevent the progression of the disease, which consumes a significant amount of health care resources and is an important cause of mortality worldwide. Current national and international guidelines for the management of stable COPD patients recommend the use of inhaled long-acting bronchodilators, inhaled corticosteroids, and their combination for maintenance treatment of moderate to severe stable COPD. Once-daily Fluticasone Furoate/vilanterol dry powder inhaler combination therapy has recently been approved by the US Food and Drug Administration and the European Medicines Agency as a new regular treatment for patients with stable COPD. Fluticasone Furoate/vilanterol dry powder inhaler combination therapy has been shown to be effective in many controlled clinical trials involving thousands of patients in the regular treatment of stable COPD. This is the first once-daily combination of ultra-long-acting inhaled β2-agonists and inhaled glucocorticoids that is available for the treatment of stable COPD and has great potential to improve compliance to long-term regular inhaled therapy and hence to improve the natural history and prognosis of COPD patients.
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Profile of Fluticasone Furoate/vilanterol dry powder inhaler combination therapy as a potential treatment for COPD
International journal of chronic obstructive pulmonary disease, 2014Co-Authors: Gaetano Caramori, Kian Fan Chung, Ian M AdcockAbstract:Currently, there is no cure for chronic obstructive pulmonary disease (COPD). The limited efficacy of current therapies for COPD indicates a pressing need to develop new treatments to prevent the progression of the disease, which consumes a significant amount of health care resources and is an important cause of mortality worldwide. Current national and international guidelines for the management of stable COPD patients recommend the use of inhaled long-acting bronchodilators, inhaled corticosteroids, and their combination for maintenance treatment of moderate to severe stable COPD. Once-daily Fluticasone Furoate/vilanterol dry powder inhaler combination therapy has recently been approved by the US Food and Drug Administration and the European Medicines Agency as a new regular treatment for patients with stable COPD. Fluticasone Furoate/vilanterol dry powder inhaler combination therapy has been shown to be effective in many controlled clinical trials involving thousands of patients in the regular treatment of stable COPD. This is the first once-daily combination of ultra-long-acting inhaled β2-agonists and inhaled glucocorticoids that is available for the treatment of stable COPD and has great potential to improve compliance to long-term regular inhaled therapy and hence to improve the natural history and prognosis of COPD patients.
William W. Busse - One of the best experts on this subject based on the ideXlab platform.
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Integrated safety and efficacy analysis of once-daily Fluticasone Furoate for the treatment of asthma
Respiratory research, 2016Co-Authors: Paul M. O'byrne, Loretta Jacques, Caroline Goldfrad, Namhee Kwon, Michael Perrio, Louisa Yates, William W. BusseAbstract:Fluticasone Furoate is a once-daily inhaled corticosteroid. This report provides an overview of safety and efficacy data that support the use of once-daily Fluticasone Furoate 100 μg or 200 μg in adult and adolescent asthma patients. Fourteen clinical studies (six Phase II and eight Phase III) were conducted as part of the Fluticasone Furoate global clinical development programme in asthma. Safety data from 10 parallel-group, randomised, double-blind Phase II and III studies (including 3345 patients who received at least one dose of Fluticasone Furoate) were integrated to provide information on adverse events, withdrawals, laboratory assessments, vital signs and hypothalamic-pituitary-adrenal axis function. The efficacy of once-daily Fluticasone Furoate was evaluated in all included studies. Once-daily Fluticasone Furoate 100 μg and 200 μg safety profiles were consistent with those reported for other inhaled corticosteroids, and both doses consistently demonstrated efficacy versus placebo. In the integrated analysis, no dose-response relationship was observed for the overall incidence of adverse events and there were no significant effects of Fluticasone Furoate on hypothalamic-pituitary-adrenal axis function. Once-daily Fluticasone Furoate 100 μg and 200 μg had acceptable safety profiles and was efficacious in adult and adolescent patients with asthma. There was no evidence of cortisol suppression at studied doses. GSK (NCT01499446/FFA20001, NCT00398645/FFA106783, NCT00766090/112202, NCT00603746/FFA109684, NCT00603278/FFA109685, NCT00603382/FFA109687, NCT01436071/115283, NCT01436110/115285, NCT01159912/112059, NCT01431950/114496, NCT01165138/HZA106827, NCT01086384/106837, NCT01134042/HZA106829 and NCT01244984/1139879).
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Efficacy and safety of once-daily Fluticasone Furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial
Respiratory research, 2014Co-Authors: Paul M. O'byrne, Loretta Jacques, Ashley Woodcock, Eugene R. Bleecker, Jan Lötvall, Eric D. Bateman, Richard Forth, Hilary Medley, William W. BusseAbstract:Background Fluticasone Furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy.
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Fluticasone Furoate-vilanterol 100-25 mcg compared with Fluticasone Furoate 100 mcg in asthma: a randomized trial.
The journal of allergy and clinical immunology. In practice, 2014Co-Authors: Eugene R. Bleecker, Paul M. O'byrne, William W. Busse, Ashley Woodcock, Jan Lötvall, Richard Forth, Hilary Medley, Edward Kerwin, Carol Nunn, Loretta JacquesAbstract:Background The inhaled corticosteroid Fluticasone Furoate (FF) in combination with the long-acting β 2 -agonist vilanterol (VI) is under development for the treatment of asthma and chronic obstructive pulmonary disease. Objective To compare the efficacy and safety of FF-VI and FF in patients (≥12 years old) with persistent asthma. Methods In a randomized, double-blind, parallel-group study, patients (n = 609) (intent-to-treat population) received FF-VI 100-25 mcg, FF 100 mcg, or placebo once daily (evening) by using a dry powder inhaler for 12 weeks. Coprimary end points were change from baseline in trough FEV 1 and serial (0-24 hours) weighted mean FEV 1 (wmFEV 1 ). Rescue-free 24-hour periods and safety also were assessed. Results Placebo increased trough FEV 1 (196 mL) and wmFEV 1 (212 mL) versus baseline. Compared with placebo, FF-VI and FF significantly improved trough FEV 1 (172 mL [ P P = .002]), respectively, and serial wmFEV 1 (302 mL [ P P = .003]), respectively. Treatment differences between FF-VI and FF approached significance for serial wmFEV 1 (116 mL; P = .060) but not for trough FEV 1 (36 mL; P = .405). The percentage of rescue-free 24-hour periods with FF-VI was 10.6% greater than FF and 19.3% greater than placebo. Statistically significant ( P = .032) urinary cortisol suppression was observed with FF-VI (ratio, 0.82) relative to placebo, but not with FF. Adverse event and safety profiles were similar across treatment groups. Conclusions Significant improvement in lung function was observed with FF-VI and FF versus placebo in patients with persistent asthma. Improvement of FEV 1 when VI was added to FF was not significant. The high placebo response in evening trough FEV 1 may have influenced the assessment of efficacy.
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authors reply to safety and tolerability of Fluticasone Furoate vilanterol
Thorax, 2013Co-Authors: William W. Busse, Leslie AndersenAbstract:We thank Dr Lipworth for his response to our article on the safety and tolerability of Fluticasone Furoate/vilanterol (FF/VI) combination in asthma,1 in which he specifically discusses effects on urinary cortisol. We acknowledge the limitations of urinary cortisol assessment; however, as outlined in the online supplement, the urinary cortisol population in our study specifically excluded subjects with an incomplete urine collection and/or 24-h urinary creatinine levels below the lower limit of the threshold range. Thus, our data are not confounded …
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Authors’ reply to ‘Safety and tolerability of Fluticasone Furoate/vilanterol’
Thorax, 2013Co-Authors: William W. Busse, Leslie AndersenAbstract:We thank Dr Lipworth for his response to our article on the safety and tolerability of Fluticasone Furoate/vilanterol (FF/VI) combination in asthma,1 in which he specifically discusses effects on urinary cortisol. We acknowledge the limitations of urinary cortisol assessment; however, as outlined in the online supplement, the urinary cortisol population in our study specifically excluded subjects with an incomplete urine collection and/or 24-h urinary creatinine levels below the lower limit of the threshold range. Thus, our data are not confounded …
Jan Lötvall - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and safety of once-daily Fluticasone Furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial
Respiratory research, 2014Co-Authors: Paul M. O'byrne, Loretta Jacques, Ashley Woodcock, Eugene R. Bleecker, Jan Lötvall, Eric D. Bateman, Richard Forth, Hilary Medley, William W. BusseAbstract:Background Fluticasone Furoate (FF) is a novel, once-daily inhaled corticosteroid (ICS) that has been shown to improve lung function vs. placebo in asthma patients. This study evaluated the efficacy and safety of FF 50 mcg compared with placebo in asthma patients uncontrolled by non-ICS therapy.
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Fluticasone Furoate-vilanterol 100-25 mcg compared with Fluticasone Furoate 100 mcg in asthma: a randomized trial.
The journal of allergy and clinical immunology. In practice, 2014Co-Authors: Eugene R. Bleecker, Paul M. O'byrne, William W. Busse, Ashley Woodcock, Jan Lötvall, Richard Forth, Hilary Medley, Edward Kerwin, Carol Nunn, Loretta JacquesAbstract:Background The inhaled corticosteroid Fluticasone Furoate (FF) in combination with the long-acting β 2 -agonist vilanterol (VI) is under development for the treatment of asthma and chronic obstructive pulmonary disease. Objective To compare the efficacy and safety of FF-VI and FF in patients (≥12 years old) with persistent asthma. Methods In a randomized, double-blind, parallel-group study, patients (n = 609) (intent-to-treat population) received FF-VI 100-25 mcg, FF 100 mcg, or placebo once daily (evening) by using a dry powder inhaler for 12 weeks. Coprimary end points were change from baseline in trough FEV 1 and serial (0-24 hours) weighted mean FEV 1 (wmFEV 1 ). Rescue-free 24-hour periods and safety also were assessed. Results Placebo increased trough FEV 1 (196 mL) and wmFEV 1 (212 mL) versus baseline. Compared with placebo, FF-VI and FF significantly improved trough FEV 1 (172 mL [ P P = .002]), respectively, and serial wmFEV 1 (302 mL [ P P = .003]), respectively. Treatment differences between FF-VI and FF approached significance for serial wmFEV 1 (116 mL; P = .060) but not for trough FEV 1 (36 mL; P = .405). The percentage of rescue-free 24-hour periods with FF-VI was 10.6% greater than FF and 19.3% greater than placebo. Statistically significant ( P = .032) urinary cortisol suppression was observed with FF-VI (ratio, 0.82) relative to placebo, but not with FF. Adverse event and safety profiles were similar across treatment groups. Conclusions Significant improvement in lung function was observed with FF-VI and FF versus placebo in patients with persistent asthma. Improvement of FEV 1 when VI was added to FF was not significant. The high placebo response in evening trough FEV 1 may have influenced the assessment of efficacy.
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Efficacy and safety of 4 weeks' treatment with combined Fluticasone Furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial
BMJ open, 2012Co-Authors: Jan Lötvall, Courtney Crim, Catherine Scott-wilson, Lisa Sanford, Per Bakke, Leif Bjermer, Sigurd Steinshamn, Brett HaumannAbstract:Background: Fluticasone Furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/longacting b2 agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma.
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efficacy and safety of 4 weeks treatment with combined Fluticasone Furoate vilanterol in a single inhaler given once daily in copd a placebo controlled randomised trial
BMJ Open, 2012Co-Authors: Jan Lötvall, Courtney Crim, Lisa Sanford, Per Bakke, Leif Bjermer, Sigurd Steinshamn, Catherine Scottwilson, Brett HaumannAbstract:Background: Fluticasone Furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/longacting b2 agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma.
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Fluticasone Furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma
Respiratory research, 2011Co-Authors: Ashley Woodcock, Loretta Jacques, William W. Busse, Lucy Frith, Eugene R. Bleecker, Jan Lötvall, Neil G. Snowise, Brett Haumann, Eric D. BatemanAbstract:Background Inhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal. The objectives of this study were to compare the efficacy and safety of once-daily (OD) evening and twice-daily (BD) regimens of the novel inhaled corticosteroid Fluticasone Furoate (FF) in asthma patients.