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Sanjeeva Dissanayake - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of Fluticasone propionate formoterol fumarate in pediatric asthma patients a randomized controlled trial
Therapeutic Advances in Respiratory Disease, 2018Co-Authors: Anna Ploszczuk, Miroslava Bosheva, Kay Spooner, Tammy Mciver, Sanjeeva DissanayakeAbstract:Background:The efficacy and safety of Fluticasone propionate/formoterol fumarate pressurized metered-dose inhaler (pMDI) (Fluticasone/formoterol; Flutiform®; 100/10 µg b.i.d.) was compared with flu...
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Efficacy and safety of Fluticasone propionate/formoterol fumarate in pediatric asthma patients: a randomized controlled trial
SAGE Publishing, 2018Co-Authors: Anna Płoszczuk, Miroslava Bosheva, Kay Spooner, Tammy Mciver, Sanjeeva DissanayakeAbstract:Background: The efficacy and safety of Fluticasone propionate/formoterol fumarate pressurized metered-dose inhaler (pMDI) (Fluticasone/formoterol; Flutiform ® ; 100/10 µg b.i.d.) was compared with Fluticasone propionate (Flixotide ® Evohaler ® pMDI; 100 µg b.i.d.) and Fluticasone/salmeterol (Seretide ® Evohaler ® pMDI; 100/50 µg b.i.d.) in a pediatric asthma population (EudraCT number: 2010-024635-16). Methods: A double-blind, double-dummy, parallel group, multicenter study. Patients, aged 5–
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long term Fluticasone propionate formoterol fumarate combination therapy is associated with a low incidence of severe asthma exacerbations
Journal of Aerosol Medicine and Pulmonary Drug Delivery, 2016Co-Authors: Alberto Papi, Tammy Mciver, Tetyana Pertseva, Kirsten Kaiser, Adel H Mansur, Birgit Grothe, Sanjeeva DissanayakeAbstract:Abstract Background: A primary goal of asthma management is the reduction of exacerbation risk. We assessed the occurrence of oral corticosteroid-requiring exacerbations (OCS exacerbations) with long-term Fluticasone/formoterol therapy, and compared it with the occurrence of similar events reported with other inhaled corticosteroid/long acting β2-agonist (ICS/LABA) combinations. Methods: The occurrence of OCS exacerbations was assessed in two open-label trials of fixed-dose Fluticasone/formoterol administered for between 26 to 60 weeks in adults and adolescents with asthma. The incidence of OCS exacerbations with Fluticasone/formoterol was compared with those reported in three recent Cochrane meta-analyses of other ICS/LABAs. Results: The pooled incidence of OCS exacerbations with long-term Fluticasone/formoterol was 2.1% (95% CI: 1.1, 3.2%, n/N = 16/752). In only two of the nineteen treatment arms summarized by Cochrane did OCS exacerbation incidence approximate that seen in the two Fluticasone/formotero...
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efficacy of Fluticasone propionate formoterol fumarate in the treatment of asthma a pooled analysis
Respiratory Medicine, 2015Co-Authors: Alberto Papi, Tammy Mciver, Kirsten Kaiser, David Price, Joaquin Sastre, Mark Lomax, Sanjeeva DissanayakeAbstract:Summary Background Fluticasone propionate and formoterol fumarate have been combined in a single inhaler (Fluticasone/formoterol; flutiform ® ) for the maintenance treatment of asthma. This pooled analysis assessed the efficacy of Fluticasone/formoterol versus Fluticasone in patients who previously received inhaled corticosteroids. Methods Data were pooled from five randomised studies in patients with asthma (aged ≥12 years) treated for 8 or 12 weeks with Fluticasone/formoterol (100/10, 250/10 or 500/20 μg b.i.d.; n = 528 delivered via pMDI) or Fluticasone alone (100, 250 or 500 μg b.i.d.; n = 527). Results Fluticasone/formoterol provided significantly greater increases than Fluticasone alone in mean morning forced expiratory volume in 1 second (FEV 1 ) from pre-dose at baseline to 2 hours post-dose at study end (least-squares mean [LSM] treatment difference: 0.146L; p 1 from baseline to study end (LSM treatment difference: 0.048 L; p = 0.043). Compared with Fluticasone, Fluticasone/formoterol provided greater increases in the percentage of asthma control days (no symptoms, no rescue medication use and no sleep disturbance due to asthma) from baseline to study end (LSM treatment difference: 8.6%; p p = 0.014). Conclusions In summary, Fluticasone/formoterol provides clinically significant improvements in lung function and asthma control measures, with a lower incidence of exacerbations than Fluticasone alone.
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superiority of Fluticasone propionate formoterol fumarate versus Fluticasone propionate alone in patients with moderate to severe asthma a randomised controlled trial
Current Medical Research and Opinion, 2013Co-Authors: Tetyana Pertseva, Sanjeeva Dissanayake, Kirsten KaiserAbstract:AbstractObjective:To demonstrate the efficacy and safety of Fluticasone propionate/formoterol fumarate (flutiform) in a pressurised metered-dose inhaler (pMDI) compared to two formulations of the Fluticasone propionate component (Skyepharma Fluticasone [SKP FP] or Flovent, GlaxoSmithKline [GSK FP]) in adults and adolescents with moderate-to-severe asthma.Methods:Patients included in the study were ≥12 years, with symptomatic asthma for ≥1 year, steroid-requiring, had a forced expiratory volume in the first second (FEV1) of 40% to 80% (inclusive) of predicted normal values, and documented reversibility within 12 months of the study. Albuterol/salbuterol was given as rescue medication. The primary efficacy endpoint was the change in FEV1 from morning pre-dose at baseline (week 0) to 2 hours post-dose at week 12 for Fluticasone/formoterol compared to SKP FP and, additionally, compared to GSK FP.Results:Fluticasone/formoterol was demonstrated to be statistically significantly superior to SKP FP. The least squ...
Robert S. Zeiger - One of the best experts on this subject based on the ideXlab platform.
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cost effectiveness analysis of Fluticasone versus montelukast in children with mild to moderate persistent asthma in the pediatric asthma controller trial
The Journal of Allergy and Clinical Immunology, 2011Co-Authors: Li Wang, Robert S. Zeiger, Christopher S Hollenbeak, David T Mauger, Ian M Paul, Christine A Sorkness, Robert F Lemanske, Fernando D Martinez, Robert C StrunkAbstract:Background Cost-effectiveness analyses of asthma controller regimens for adults exist, but similar evaluations exclusively for children are few. Objective We sought to compare the cost-effectiveness of 2 commonly used asthma controllers, Fluticasone and montelukast, with data from the Pediatric Asthma Controller Trial. Methods We compared the cost-effectiveness of low-dose Fluticasone with that of montelukast in a randomized, controlled, multicenter clinical trial in children with mild-to-moderate persistent asthma. Analyses were also conducted on subgroups based on phenotypic factors. Effectiveness measures included (1) the number of asthma-control days, (2) the percentage of participants with an increase over baseline of FEV 1 of 12% or greater, and (3) the number of exacerbations avoided. Costs were analyzed from both a US health care payer's perspective and a societal perspective. Results For all cost-effectiveness measures studied, Fluticasone cost less and was more effective than montelukast. For example, Fluticasone treatment cost $430 less in mean direct cost ( P P 20 subgroup (PC 20 Conclusion For children with mild-to-moderate persistent asthma, low-dose Fluticasone had lower cost and higher effectiveness compared with montelukast, especially in those with more airway inflammation, as indicated by increased levels of eNO and more responsivity to methacholine.
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long term comparison of 3 controller regimens for mild moderate persistent childhood asthma the pediatric asthma controller trial
The Journal of Allergy and Clinical Immunology, 2007Co-Authors: Christine A Sorkness, Robert S. Zeiger, David T Mauger, Robert F Lemanske, Fernando D Martinez, Robert C Strunk, Susan J Boehmer, Vernon M Chinchilli, Stanley J SzeflerAbstract:Background More evidence is needed on which to base recommendations for treatment of mild-moderate persistent asthma in school-aged children. Objective The Pediatric Asthma Controller Trial (PACT) compared the effectiveness of 3 regimens in achieving asthma control. Methods A total of 285 children (ages 6-14 years) with mild-moderate persistent asthma on the basis of symptoms, and with FEV 1 ≥ 80% predicted and methacholine FEV 1 PC 20 ≤ 12.5 mg/mL, were randomized to 1 of 3 double-blind 48-week treatments: Fluticasone 100 μg twice daily (Fluticasone monotherapy), Fluticasone 100 μg/salmeterol 50 μg in the morning and salmeterol 50 μg in the evening (PACT combination), and montelukast 5 mg in the evening. Outcomes included asthma control days (primary outcome), exacerbations, humanistic measurements, and pulmonary function measurements. Results Fluticasone monotherapy and PACT combination were comparable in many patient-measured outcomes, including percent of asthma control days, but Fluticasone monotherapy was superior for clinic-measured FEV 1 /forced vital capacity ( P = .015), maximum bronchodilator response ( P = .009), exhaled nitric oxide ( P .001), and PC 20 ( P .001). Fluticasone monotherapy was superior to montelukast for asthma control days (64.2% vs 52.5%; P = .004) and for all other control outcomes. Growth over 48 weeks was not statistically different (Fluticasone, 5.3 cm; PACT combination, 5.3 cm; montelukast, 5.7 cm). Conclusion Both Fluticasone monotherapy and PACT combination achieved greater improvements in asthma control days than montelukast. However, Fluticasone monotherapy was superior to PACT combination in achieving other dimensions of asthma control. Growth was similar in all groups. Clinical implications Therefore, of the regimens tested, the PACT study findings favor Fluticasone monotherapy in treating children with mild-moderate persistent asthma with FEV 1 ≥ 80% predicted, confirming current guideline recommendations.
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Short-term and long-term asthma control in patients with mild persistent asthma receiving montelukast or Fluticasone: a randomized controlled trial
The American journal of medicine, 2005Co-Authors: E. John Orav, Robert S. Zeiger, Michael S. Kaplan, David S. Pearlman, Michael Schatz, Steven R. Bird, Carolyn M. Hustad, Jonathan M. EdelmanAbstract:Abstract Purpose To determine whether montelukast is as effective as Fluticasone in controlling mild persistent asthma as determined by rescue-free days. Subjects and methods Participants aged 15 to 85 years with mild persistent asthma (n = 400) were randomized to oral montelukast (10 mg once nightly) or inhaled Fluticasone (88 μg twice daily) in a year-long, parallel-group, multicenter study with a 12-week, double-blind period, followed by a 36-week, open-label period. Results The mean percentage of rescue-free days was similar between treatments after 12 weeks (Fluticasone: 74.9%, montelukast: 73.1%; difference=1.8%, 95% confidence interval [CI]: −3.2% to 6.8%) but not during the open-label period (Fluticasone: 77.3%, montelukast: 71.1%; difference=6.2%, 95% CI: 0.8% to 11.7%). Although both Fluticasone and montelukast significantly improved symptoms, quality of life, and symptom-free days during both treatment periods, greater improvements occurred with Fluticasone in lung function during both periods and in asthma control during open-label treatment. Post hoc analyses revealed a difference in rescue-free days favoring Fluticasone in participants in the quartiles for lowest lung function and greatest albuterol use at baseline. Conclusion In patients with mild persistent asthma, rescue-free days and most asthma control measures improved similarly with Fluticasone or montelukast over the short term, but with prolonged open-label treatment, asthma control improved more with Fluticasone. Improved asthma control with Fluticasone appeared to occur in those with decreased lung function and greater albuterol use at baseline. In the remaining patients, the two treatments appeared to be comparable. These results suggest that classification criteria for mild persistent asthma may need to be re-evaluated.
Eric D. Bateman - One of the best experts on this subject based on the ideXlab platform.
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global initiative for asthma 2016 derived asthma control with Fluticasone propionate and salmeterol a gaining optimal asthma control goal study reanalysis
Annals of Allergy Asthma & Immunology, 2019Co-Authors: Eric D. Bateman, Jean Bousquet, William W. Busse, Soren Pedersen, Shaoguang Huang, Xin Zhou, Nadeem Gul, Sally Hollis, Michael GibbsAbstract:Abstract Background In 2004, the landmark Gaining Optimal Asthma Control (GOAL) study demonstrated that most patients can achieve asthma control through sustained treatment and that adding a long-acting β2-adrenoreceptor agonist to an inhaled corticosteroid (ICS) is more effective than ICS alone in this regard. Definitions of asthma control have since evolved, and the consequent implications for the GOAL study findings are unclear. Objective To evaluate the efficacy of Fluticasone propionate and salmeterol and Fluticasone propionate alone in achieving and maintaining asthma control, as derived from the Global Initiative for Asthma (GINA) 2016 report. Methods In total, 3416 patients were stratified by prior medication (ICS-naive [stratum 1], low-dose ICS [stratum 2], or medium-dose ICS [stratum 3]) and randomized to receive Fluticasone propionate and salmeterol or Fluticasone propionate. The primary end point was the proportion of patients achieving well-controlled or partly controlled asthma; secondary end points included the proportion of patients achieving well-controlled asthma. Control was evaluated during the last 4 weeks of each dose titration. Results In all strata, more patients achieved well-controlled or partly controlled asthma with Fluticasone propionate and salmeterol vs Fluticasone propionate alone (stratum 1: 91% vs 85%; P = .003; stratum 2: 86% vs 82%; P = .07; and stratum 3: 76% vs 66%; P Conclusion A markedly higher proportion of patients with uncontrolled asthma in each stratum achieved control according to GINA 2016 criteria compared with the original study criteria. The proportion of patients achieving control remained greater with Fluticasone propionate and salmeterol than with Fluticasone propionate alone.
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A randomized study comparing ciclesonide and Fluticasone propionate in patients with moderate persistent asthma
Respiratory medicine, 2007Co-Authors: Louis-philippe Boulet, Eric D. Bateman, Robert Voves, Thomas Müller, Susanne Wolf, Renate EngelstätterAbstract:Summary Objective To compare the effects of once-daily ciclesonide and twice-daily Fluticasone propionate in patients with moderate persistent asthma. Methods Patients aged 12–75 years with moderate bronchial asthma entered a 1–4 week run-in period. For inclusion into the 12-week, randomized, open-label treatment period, patients had to have a forced expiratory volume in 1s (FEV 1 ) of either 60–80% of predicted or ⩾80% of predicted and a defined use of rescue medication and asthma symptoms, depending on previous treatment. Patients received ciclesonide 320μg once daily (ex-actuator) or Fluticasone propionate 200μg twice daily. Primary efficacy endpoint was change from baseline in FEV 1 . Results In total, 474 patients were randomized. FEV 1 increased significantly from baseline with ciclesonide and Fluticasone propionate in the intention-to-treat (ITT) and per-protocol (PP) analyses (all p p p =0.005; one-sided). There were no cases of oral candidiasis in patients receiving ciclesonide and nine cases (3.8%) in those receiving Fluticasone propionate ( p =0.002; one-sided). Conclusions Treatment with once-daily ciclesonide and twice-daily Fluticasone propionate resulted in similar improvements in lung function in patients with moderate persistent asthma. Ciclesonide showed significant improvements in oral candidiasis and HRQoL over Fluticasone.
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can guideline defined asthma control be achieved the gaining optimal asthma control study
American Journal of Respiratory and Critical Care Medicine, 2004Co-Authors: Eric D. Bateman, Jean Bousquet, William W. Busse, Homer A Boushey, Tim J Clark, Romain Pauwels, Soren PedersenAbstract:For most patients, asthma is not controlled as defined by guidelines; whether this is achievable has not been prospectively studied. A 1-year, randomized, stratified, double-blind, parallel-group study of 3,421 patients with uncontrolled asthma compared Fluticasone propionate and salmeterol/Fluticasone in achieving two rigorous, composite, guideline-based measures of control: totally and well-controlled asthma. Treatment was stepped-up until total control was achieved (or maximum 500 g corticosteroid twice a day). Significantly more patients in each stratum (previously corticosteroid-free, low- and moderate-dose corticosteroid users) achieved control with salmeterol/Fluticasone than Fluticasone. Total control was achieved across all strata: 520 (31%) versus 326 (19%) patients after dose escalation (p 0.001) and 690 (41%) versus 468 (28%) at 1 year for salmeterol/Fluticasone and Fluticasone, respectively. Asthma became well controlled in 1,071 (63%) versus 846 (50%) after dose escalation (p 0.001) and 1,204 (71%) versus 988 (59%) at 1 year. Control was achieved more rapidly and at a lower corticosteroid dose with salmeterol/Fluticasone versus Fluticasone. Across all strata, 68% and 76% of the patients receiving salmeterol/Fluticasone and Fluticasone, respectively, were on the highest dose at the end of treatment. Exacerbation rates (0.07–0.27 per patient per year) and improvement in health status were significantly better with salmeterol/ Fluticasone. This study confirms that the goal of guideline-derived asthma control was achieved in a majority of the patients.
William W. Busse - One of the best experts on this subject based on the ideXlab platform.
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global initiative for asthma 2016 derived asthma control with Fluticasone propionate and salmeterol a gaining optimal asthma control goal study reanalysis
Annals of Allergy Asthma & Immunology, 2019Co-Authors: Eric D. Bateman, Jean Bousquet, William W. Busse, Soren Pedersen, Shaoguang Huang, Xin Zhou, Nadeem Gul, Sally Hollis, Michael GibbsAbstract:Abstract Background In 2004, the landmark Gaining Optimal Asthma Control (GOAL) study demonstrated that most patients can achieve asthma control through sustained treatment and that adding a long-acting β2-adrenoreceptor agonist to an inhaled corticosteroid (ICS) is more effective than ICS alone in this regard. Definitions of asthma control have since evolved, and the consequent implications for the GOAL study findings are unclear. Objective To evaluate the efficacy of Fluticasone propionate and salmeterol and Fluticasone propionate alone in achieving and maintaining asthma control, as derived from the Global Initiative for Asthma (GINA) 2016 report. Methods In total, 3416 patients were stratified by prior medication (ICS-naive [stratum 1], low-dose ICS [stratum 2], or medium-dose ICS [stratum 3]) and randomized to receive Fluticasone propionate and salmeterol or Fluticasone propionate. The primary end point was the proportion of patients achieving well-controlled or partly controlled asthma; secondary end points included the proportion of patients achieving well-controlled asthma. Control was evaluated during the last 4 weeks of each dose titration. Results In all strata, more patients achieved well-controlled or partly controlled asthma with Fluticasone propionate and salmeterol vs Fluticasone propionate alone (stratum 1: 91% vs 85%; P = .003; stratum 2: 86% vs 82%; P = .07; and stratum 3: 76% vs 66%; P Conclusion A markedly higher proportion of patients with uncontrolled asthma in each stratum achieved control according to GINA 2016 criteria compared with the original study criteria. The proportion of patients achieving control remained greater with Fluticasone propionate and salmeterol than with Fluticasone propionate alone.
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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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can guideline defined asthma control be achieved the gaining optimal asthma control study
American Journal of Respiratory and Critical Care Medicine, 2004Co-Authors: Eric D. Bateman, Jean Bousquet, William W. Busse, Homer A Boushey, Tim J Clark, Romain Pauwels, Soren PedersenAbstract:For most patients, asthma is not controlled as defined by guidelines; whether this is achievable has not been prospectively studied. A 1-year, randomized, stratified, double-blind, parallel-group study of 3,421 patients with uncontrolled asthma compared Fluticasone propionate and salmeterol/Fluticasone in achieving two rigorous, composite, guideline-based measures of control: totally and well-controlled asthma. Treatment was stepped-up until total control was achieved (or maximum 500 g corticosteroid twice a day). Significantly more patients in each stratum (previously corticosteroid-free, low- and moderate-dose corticosteroid users) achieved control with salmeterol/Fluticasone than Fluticasone. Total control was achieved across all strata: 520 (31%) versus 326 (19%) patients after dose escalation (p 0.001) and 690 (41%) versus 468 (28%) at 1 year for salmeterol/Fluticasone and Fluticasone, respectively. Asthma became well controlled in 1,071 (63%) versus 846 (50%) after dose escalation (p 0.001) and 1,204 (71%) versus 988 (59%) at 1 year. Control was achieved more rapidly and at a lower corticosteroid dose with salmeterol/Fluticasone versus Fluticasone. Across all strata, 68% and 76% of the patients receiving salmeterol/Fluticasone and Fluticasone, respectively, were on the highest dose at the end of treatment. Exacerbation rates (0.07–0.27 per patient per year) and improvement in health status were significantly better with salmeterol/ Fluticasone. This study confirms that the goal of guideline-derived asthma control was achieved in a majority of the patients.
Edward E Philpot - One of the best experts on this subject based on the ideXlab platform.
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Effect of once-daily Fluticasone furoate nasal spray on nasal symptoms in adults and adolescents with perennial allergic rhinitis.
Annals of allergy asthma & immunology : official publication of the American College of Allergy Asthma & Immunology, 2008Co-Authors: Robert A. Nathan, William E. Berger, William H. Yang, Amarjit Cheema, Maryjane Silvey, Edward E PhilpotAbstract:Background Intranasal corticosteroids are recommended as first-line therapy for the treatment of allergic rhinitis. Fluticasone furoate is a novel enhanced-affinity glucocorticoid for the treatment of allergic rhinitis. Objective To compare the efficacy and safety of intranasal Fluticasone furoate with those of vehicle placebo nasal spray in adult and adolescent patients with perennial allergic rhinitis (PAR). Methods After screening (7-14 days), patients 12 years and older with confirmed PAR were randomized to receive Fluticasone furoate, 110 μg once daily, or placebo once daily intranasally for 4 weeks in this double-blind, multicenter study. The primary end point was mean change from baseline during the entire treatment period in daily reflective total nasal symptom score (rTNSS), recorded on diary cards by patients, using a 4-point categorical scale. Results The mean reduction from baseline during the treatment period in daily rTNSS was significantly greater in Fluticasone furoate recipients than in placebo recipients ( P = .005). This finding was supported by significantly greater mean reductions in morning rTNSS and evening rTNSS ( P = .004 and P = .011, respectively). A significantly greater mean reduction in instantaneous morning predose TNSS with Fluticasone furoate compared with placebo ( P = .006) confirmed the efficacy of once-daily administration. Fluticasone furoate was also significantly more effective than placebo in overall response to therapy ( P = .005). Conclusions Fluticasone furoate nasal spray, 110 μg once daily, effectively relieved nasal symptoms of PAR in adults and adolescents 12 years and older.
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Fluticasone furoate nasal spray a single treatment option for the symptoms of seasonal allergic rhinitis
The Journal of Allergy and Clinical Immunology, 2007Co-Authors: Harold B Kaiser, Robert M. Naclerio, J Given, T Toler, A Ellsworth, Edward E PhilpotAbstract:Background Fluticasone furoate (USAN-approved name) is a novel, enhanced-affinity glucocorticoid administered in a unique side-actuated device for the management of seasonal allergic rhinitis (SAR). Objective We sought to evaluate the efficacy and safety of once-daily Fluticasone furoate nasal spray, 110 μg, in patients aged 12 years or older with fall SAR. Methods Patients (n = 299) received Fluticasone furoate or placebo for 2 weeks in this double-blind, parallel-group randomized study. Patients evaluated nasal and ocular symptoms using a 4-point categoric scale. Efficacy was assessed on the basis of the mean change from baseline in reflective and instantaneous total nasal symptom scores and reflective total ocular symptom scores. Results Fluticasone furoate produced significantly greater improvements than placebo in daily reflective total nasal symptom score (−1.473, P P P = .004), and patient-rated overall response to therapy ( P Conclusion Fluticasone furoate, 110 μg once daily, was effective and well tolerated for the treatment of nasal symptoms of SAR in patients aged 12 years and older. Treatment also produced significant improvements in ocular symptoms. Fluticasone furoate was fast acting, as indicated by an 8-hour onset of action, and provided 24-hour symptom control. Clinical implications New treatments for the bothersome symptoms of SAR are needed. One such treatment, Fluticasone furoate nasal spray, provides effective relief of the symptom profile of SAR.
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Fluticasone furoate nasal spray: a single treatment option for the symptoms of seasonal allergic rhinitis.
The Journal of allergy and clinical immunology, 2007Co-Authors: Harold B Kaiser, Robert M. Naclerio, J Given, T Toler, A Ellsworth, Edward E PhilpotAbstract:Background Fluticasone furoate (USAN-approved name) is a novel, enhanced-affinity glucocorticoid administered in a unique side-actuated device for the management of seasonal allergic rhinitis (SAR). Objective We sought to evaluate the efficacy and safety of once-daily Fluticasone furoate nasal spray, 110 μg, in patients aged 12 years or older with fall SAR. Methods Patients (n = 299) received Fluticasone furoate or placebo for 2 weeks in this double-blind, parallel-group randomized study. Patients evaluated nasal and ocular symptoms using a 4-point categoric scale. Efficacy was assessed on the basis of the mean change from baseline in reflective and instantaneous total nasal symptom scores and reflective total ocular symptom scores. Results Fluticasone furoate produced significantly greater improvements than placebo in daily reflective total nasal symptom score (−1.473, P P P = .004), and patient-rated overall response to therapy ( P Conclusion Fluticasone furoate, 110 μg once daily, was effective and well tolerated for the treatment of nasal symptoms of SAR in patients aged 12 years and older. Treatment also produced significant improvements in ocular symptoms. Fluticasone furoate was fast acting, as indicated by an 8-hour onset of action, and provided 24-hour symptom control. Clinical implications New treatments for the bothersome symptoms of SAR are needed. One such treatment, Fluticasone furoate nasal spray, provides effective relief of the symptom profile of SAR.
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no growth suppression in children treated with the maximum recommended dose of Fluticasone propionate aqueous nasal spray for one year
Allergy and Asthma Proceedings, 2002Co-Authors: David B Allen, Barbara A Prillaman, Edward E Philpot, Melissa A Faris, Robert F Lemanske, Eli O Meltzer, Kenneth M Kral, Kathleen A RickardAbstract:This randomized, double-blind, placebo-controlled study of Fluticasone propionate aqueous nasal spray (at a maximum recommended dose of 200 micrograms each day) administered daily for one year was conducted to evaluate its potential effects on growth, measured by stadiometry, in prepubescent children with perennial allergic rhinitis (n = 150; age 3.5 to 9.0 years). The results demonstrate equivalent growth velocity over a one-year treatment period between children receiving Fluticasone propionate aqueous nasal spray and children receiving vehicle placebo. In addition, children in both treatment groups had similar increases in height over the same period. Baseline height was 119.1 cm (SE = 0.72) in the Fluticasone propionate group (n = 56) and 119.0 cm (SE = 0.71) in the vehicle placebo group (n = 52). Mean height at the end of one year of treatment was 125.5 cm (SE = 0.18) in the Fluticasone propionate group (n = 44) and 125.4 cm (SE = 0.19) in the vehicle placebo group (n = 39) (least-squares mean difference -0.12; 95% confidence interval [-0.600, 0.352]). The effects of Fluticasone propionate on one-year growth velocity were also comparable to those of vehicle placebo. The confidence interval for the treatment difference lay within the prospectively defined equivalence bounds (of -0.8, +0.8 cm/year) and contained zero. The incidence of adverse events considered to be at least possibly drug-related did not differ between the Fluticasone propionate group and the vehicle placebo group. The results of this one-year, double-blind study demonstrate that Fluticasone propionate aqueous nasal spray at the maximum recommended dose of two sprays per nostril (200 micrograms) once daily was equivalent to vehicle placebo with no effects on growth rate in prepubescent children.