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Kathleen Rickard - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of low dose fluticasone propionate compared with Zafirlukast in patients with persistent asthma
The American Journal of Medicine, 2002Co-Authors: John H Brabson, Sharon Srebro, Lisa D Edwards, Pamela J Pepsin, Dennis Clifford, Edward Kerwin, Gordon D Raphael, Kathleen RickardAbstract:Abstract Purpose To compare the efficacy and safety of fluticasone propionate and Zafirlukast in patients with relatively stable persistent asthma who were previously treated with inhaled corticosteroids and short-acting β 2 -agonists. Subjects and methods A total of 440 patients (≥12 years of age) previously treated with inhaled corticosteroids (beclomethasone dipropionate or triamcinolone acetonide) and short-acting β 2 -agonists were included in this randomized double-blind study. After an 8-day run-in period, patients were treated with fluticasone (88 μg) or Zafirlukast (20 mg) twice daily for 6 weeks. Outcome measures included pulmonary function (forced expiratory volume in 1 second [FEV 1 ], peak expiratory flow [peak flow]), albuterol use, asthma symptoms, withdrawals due to lack of efficacy, and asthma exacerbations. Results Patients treated with fluticasone (n = 224) experienced greater mean increases in FEV 1 (0.24 L vs. 0.08 L, P P P P P = 0.002), nights with uninterrupted sleep ( P = 0.006), and fewer asthma exacerbations (1% vs. 6%, P = 0.005). Fewer fluticasone-treated patients were withdrawn due to lack of efficacy (2% vs. 13%, P Conclusion Inhaled fluticasone was more effective than Zafirlukast in maintaining or improving asthma control in patients with relatively stable asthma who were switched from low-dose inhaled corticosteroids.
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cost efficacy analysis of fluticasone propionate versus Zafirlukast in patients with persistent asthma
PharmacoEconomics, 2001Co-Authors: Rogelio Menendez, Chris Kalberg, Lisa D Edwards, Richard H Stanford, Kathleen RickardAbstract:Objective: To compare the relative value of an inhaled corticosteroid, fluticasone propionate 88μg twice daily, versus an oral leukotriene receptor antagonist, Zafirlukast 20mg twice daily, in patients with persistent asthma currently receiving short acting β2-agonists alone. Study design: A cost-efficacy analysis using resource utilisation and clinical data obtained prospectively from a multicentre, randomised, double-blind, double-dummy, placebo-controlled 12-week clinical trial conducted in the US. Perspective: Third-party payor. Patients and methods: A total of 451 corticosteroid-naive patients with persistent asthma were treated with either fluticasone propionate 88μg twice daily or Zafirlukast 20mg twice daily. All patients were given salbutamol (albuterol) to be used as rescue medication. Data were examined using intent-to-treat analysis. Results: Mean daily per person cost-efficacy ratios using improvement in forced expiratory volume in 1 second (FEV1) [≥12% increase from baseline] were $US3.47 for fluticasone propionate compared with $US7.81 for Zafirlukast (1999 values). The mean daily per person cost-efficacy ratios for symptom-free days obtained were $US5.51 for fluticasone propionate compared with $US14.98 for Zafirlukast. These cost-efficacy ratios remained in favour of fluticasone propionate after a robust sensitivity analysis. Conclusions: Treatment with fluticasone propionate 88μg twice daily was the most cost effective treatment compared with Zafirlukast 20mg twice daily in this 12-week clinical trial. This analysis supports the use of fluticasone propionate 88μg twice daily as first-line treatment in patients with persistent asthma previously treated with short-acting β2-agonist alone.
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fluticasone propionate versus Zafirlukast effect in patients previously receiving inhaled corticosteroid therapy
Annals of Allergy Asthma & Immunology, 2000Co-Authors: Kenneth T Kim, Sharon Srebro, Lisa D Edwards, Elliot J Ginchansky, Bruce Friedman, Pamela J Pepsin, Richard H Stanford, Kathleen RickardAbstract:Background The use of inhaled corticosteroids compared with leukotriene modifying drugs in the treatment of persistent asthma has not been extensively studied. Objective To compare the efficacy and safety of a low dose of fluticasone propionate (FP) and Zafirlukast in patients previously maintained on inhaled corticosteroids. Methods Patients (≥12 years old; FEV 1 = 60% to 85% of predicted) with persistent asthma who were previously treated with low doses of triamcinolone acetonide (TAA) 400 to 800 μg/day or beclomethasone dipropionate (BDP) 168 to 336 μg/day were randomized to treatment with FP aerosol 88 μg BID (FP, n=221) or Zafirlukast 20 mg BID (n = 216) over 6 weeks. Results Treatment with FP significantly increased the mean change at endpoint (the last post-baseline observation) in FEV 1 (0.22L versus 0.03L, P P = .004), evening PEF (16.7 versus 2.6 L/min, P = .002), the percentage of symptom-free days (16.2 versus 7.1%, P = .007), and the percentage of rescue-free days (23.4 versus 9.3%, P P P P P P P = .035). Patients in the Zafirlukast group were significantly more likely to be withdrawn due to lack of efficacy ( P Conclusion Switching patients from low doses of inhaled corticosteroids to a lower total microgram dose of FP improves pulmonary function, asthma symptoms, and quality of life, while switching to the leukotriene receptor antagonist Zafirlukast may result in worsening of asthma control. This was indicated by the significant number of Zafirlukast-treated patients who were dropped from the study due to lack of efficacy within 6 weeks of discontinuing inhaled corticosteroids.
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low dose inhaled fluticasone propionate versus oral Zafirlukast in the treatment of persistent asthma
The Journal of Allergy and Clinical Immunology, 2000Co-Authors: Eugene R. Bleecker, Chris Kalberg, Lisa D Edwards, Marty Johnson, M J Welch, S F Weinstein, Kathleen RickardAbstract:Abstract Background: Few studies have compared the efficacy of inhaled corticosteroids and leukotriene modifiers for the treatment of persistent asthma. Objective: Our purpose was to compare the efficacy of a low dose of inhaled fluticasone propionate (FP) with that of oral Zafirlukast in the treatment of persistent asthma previously treated with short-acting β 2 -agonists alone. Methods: A 12-week, randomized, double-blind, double-dummy, multicenter study was conducted in 451 patients aged 12 years and older with asthma who were symptomatic on short-acting β 2 -agonists alone. After an 8- to 14-day run-in period, patients were randomized to treatment with FP 88 μg twice daily or Zafirlukast 20 mg twice daily. Results: Treatment with FP was more effective than treatment with Zafirlukast in increasing morning FEV 1 (by 0.42 L vs 0.20 L over baseline, P P P 1 were noted after the first observation (week 4) and in morning and evening peak expiratory flow by week 2. Mean change in percentage of symptom-free days was greater with FP than with Zafirlukast (28.5% of days vs 15.6% of days, P P P P Conclusion: The clinical effectiveness of a low dose of FP as first-line therapy in patients with persistent asthma who are symptomatic on β 2 -agonists alone is superior to that of Zafirlukast. (J Allergy Clin Immunol 2000;105:1123-9.)
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Comparison of inhaled salmeterol and oral Zafirlukast in patients with asthma
The Journal of allergy and clinical immunology, 1999Co-Authors: W Busse, Chris Kalberg, H. Nelson, James D. Wolfe, Steven W. Yancey, Kathleen RickardAbstract:Abstract Background: Salmeterol, a long-acting β 2 -agonist, and Zafirlukast, a leukotriene receptor antagonist, are both indicated for the treatment of asthma in adolescent and adult patients. Objective: We sought to compare the effect of 4 weeks of treatment with inhaled salmeterol xinafoate versus oral Zafirlukast in the treatment of persistent asthma. Methods: This was a randomized, double-blind, double-dummy, parallel-group, multicenter clinical trial. Patients, over 80% of whom were on a concurrent inhaled corticosteroid regimen, were treated for 4 weeks with either inhaled salmeterol xinafoate 42 μg twice daily administered by means of a metered-dose inhaler or oral Zafirlukast 20 mg twice daily. The primary efficacy measure was morning peak expiratory flow (PEF); secondary efficacy measures included evening PEF, asthma symptom scores, supplemental albuterol use, nighttime awakenings, sleep symptoms, asthma exacerbations, and FEV 1 . Results: Both inhaled salmeterol and oral Zafirlukast resulted in within-group improvements from baseline in measures of pulmonary function, asthma symptoms, and supplemental albuterol use. Salmeterol treatment resulted in significantly greater improvements from baseline compared with Zafirlukast for most efficacy measurements, including morning PEF (29.6 vs 13.0 L/min; P ≤ .001), percentage of symptom-free days (22.4% vs 8.8%; P ≤ .001), and percentage of days and nights with no supplemental albuterol use (30.5% vs 11.3%; P ≤ .001). There were no differences in safety profiles as assessed by adverse event monitoring. Conclusion: In patients with persistent asthma, most of whom were concurrently using inhaled corticosteroids, treatment with inhaled salmeterol provided significantly greater improvement than oral Zafirlukast in overall asthma control over the 4-week treatment period. (J Allergy Clin Immunol 1999;103:1075-80.)
Lisa D Edwards - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of low dose fluticasone propionate compared with Zafirlukast in patients with persistent asthma
The American Journal of Medicine, 2002Co-Authors: John H Brabson, Sharon Srebro, Lisa D Edwards, Pamela J Pepsin, Dennis Clifford, Edward Kerwin, Gordon D Raphael, Kathleen RickardAbstract:Abstract Purpose To compare the efficacy and safety of fluticasone propionate and Zafirlukast in patients with relatively stable persistent asthma who were previously treated with inhaled corticosteroids and short-acting β 2 -agonists. Subjects and methods A total of 440 patients (≥12 years of age) previously treated with inhaled corticosteroids (beclomethasone dipropionate or triamcinolone acetonide) and short-acting β 2 -agonists were included in this randomized double-blind study. After an 8-day run-in period, patients were treated with fluticasone (88 μg) or Zafirlukast (20 mg) twice daily for 6 weeks. Outcome measures included pulmonary function (forced expiratory volume in 1 second [FEV 1 ], peak expiratory flow [peak flow]), albuterol use, asthma symptoms, withdrawals due to lack of efficacy, and asthma exacerbations. Results Patients treated with fluticasone (n = 224) experienced greater mean increases in FEV 1 (0.24 L vs. 0.08 L, P P P P P = 0.002), nights with uninterrupted sleep ( P = 0.006), and fewer asthma exacerbations (1% vs. 6%, P = 0.005). Fewer fluticasone-treated patients were withdrawn due to lack of efficacy (2% vs. 13%, P Conclusion Inhaled fluticasone was more effective than Zafirlukast in maintaining or improving asthma control in patients with relatively stable asthma who were switched from low-dose inhaled corticosteroids.
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fluticasone propionate compared with Zafirlukast in controlling persistent asthma a randomized double blind placebo controlled trial
Journal of Family Practice, 2001Co-Authors: W Busse, James Wolfe, William W Storms, Sharon Srebro, Lisa D Edwards, Marty Johnson, B W Bowers, Paula R Rogenes, Kathy RickardAbstract:OBJECTIVE The objective of our study was to compare the efficacy and safety of fluticasone propionate (an inhaled corticosteroid) with Zafirlukast (a leukotriene modifier) for persistent asthma. STUDY DESIGN In this randomized placebo-controlled, parallel-group, double-blind, double-dummy trial, patients underwent an 8- to 14-day run-in period followed by 12 weeks of treatment with inhaled fluticasone propionate (88 mg twice daily by metered-dose inhaler), oral Zafirlukast (20 mg twice daily), or placebo. POPULATION We included a total of 338 persistent asthma patients, 12 years of age or older, using short-acting b2-agonists alone. OUTCOMES measured Efficacy outcomes included changes in pulmonary function, asthma symptoms, rescue albuterol use, nighttime awakenings due to asthma, and quality of life. Safety outcomes included asthma exacerbations, adverse events, and clinically significant laboratory test results. RESULTS After 12 weeks of treatment, patients taking fluticasone propionate experienced significantly greater improvements in all clinical parameters (symptom scores, percentages of symptom-free and albuterol-free days, albuterol use, and nighttime awakenings) compared with patients taking Zafirlukast (P <.05) or placebo (P <.05). Treatment with fluticasone propionate resulted in significantly greater improvements in pulmonary function compared with Zafirlukast (P <.05) or placebo (P <.05). Fewer fluticasone propionate patients (4%) had an exacerbation requiring oral corticosteroids compared with those taking Zafirlukast (12%) or placebo (10%). CONCLUSIONS Inhaled fluticasone propionate is more effective than Zafirlukast in controlling asthma symptoms, improving pulmonary function, and improving quality of life for patients who are symptomatic with the use of short-acting b2-agonists alone.
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cost efficacy analysis of fluticasone propionate versus Zafirlukast in patients with persistent asthma
PharmacoEconomics, 2001Co-Authors: Rogelio Menendez, Chris Kalberg, Lisa D Edwards, Richard H Stanford, Kathleen RickardAbstract:Objective: To compare the relative value of an inhaled corticosteroid, fluticasone propionate 88μg twice daily, versus an oral leukotriene receptor antagonist, Zafirlukast 20mg twice daily, in patients with persistent asthma currently receiving short acting β2-agonists alone. Study design: A cost-efficacy analysis using resource utilisation and clinical data obtained prospectively from a multicentre, randomised, double-blind, double-dummy, placebo-controlled 12-week clinical trial conducted in the US. Perspective: Third-party payor. Patients and methods: A total of 451 corticosteroid-naive patients with persistent asthma were treated with either fluticasone propionate 88μg twice daily or Zafirlukast 20mg twice daily. All patients were given salbutamol (albuterol) to be used as rescue medication. Data were examined using intent-to-treat analysis. Results: Mean daily per person cost-efficacy ratios using improvement in forced expiratory volume in 1 second (FEV1) [≥12% increase from baseline] were $US3.47 for fluticasone propionate compared with $US7.81 for Zafirlukast (1999 values). The mean daily per person cost-efficacy ratios for symptom-free days obtained were $US5.51 for fluticasone propionate compared with $US14.98 for Zafirlukast. These cost-efficacy ratios remained in favour of fluticasone propionate after a robust sensitivity analysis. Conclusions: Treatment with fluticasone propionate 88μg twice daily was the most cost effective treatment compared with Zafirlukast 20mg twice daily in this 12-week clinical trial. This analysis supports the use of fluticasone propionate 88μg twice daily as first-line treatment in patients with persistent asthma previously treated with short-acting β2-agonist alone.
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fluticasone propionate versus Zafirlukast effect in patients previously receiving inhaled corticosteroid therapy
Annals of Allergy Asthma & Immunology, 2000Co-Authors: Kenneth T Kim, Sharon Srebro, Lisa D Edwards, Elliot J Ginchansky, Bruce Friedman, Pamela J Pepsin, Richard H Stanford, Kathleen RickardAbstract:Background The use of inhaled corticosteroids compared with leukotriene modifying drugs in the treatment of persistent asthma has not been extensively studied. Objective To compare the efficacy and safety of a low dose of fluticasone propionate (FP) and Zafirlukast in patients previously maintained on inhaled corticosteroids. Methods Patients (≥12 years old; FEV 1 = 60% to 85% of predicted) with persistent asthma who were previously treated with low doses of triamcinolone acetonide (TAA) 400 to 800 μg/day or beclomethasone dipropionate (BDP) 168 to 336 μg/day were randomized to treatment with FP aerosol 88 μg BID (FP, n=221) or Zafirlukast 20 mg BID (n = 216) over 6 weeks. Results Treatment with FP significantly increased the mean change at endpoint (the last post-baseline observation) in FEV 1 (0.22L versus 0.03L, P P = .004), evening PEF (16.7 versus 2.6 L/min, P = .002), the percentage of symptom-free days (16.2 versus 7.1%, P = .007), and the percentage of rescue-free days (23.4 versus 9.3%, P P P P P P P = .035). Patients in the Zafirlukast group were significantly more likely to be withdrawn due to lack of efficacy ( P Conclusion Switching patients from low doses of inhaled corticosteroids to a lower total microgram dose of FP improves pulmonary function, asthma symptoms, and quality of life, while switching to the leukotriene receptor antagonist Zafirlukast may result in worsening of asthma control. This was indicated by the significant number of Zafirlukast-treated patients who were dropped from the study due to lack of efficacy within 6 weeks of discontinuing inhaled corticosteroids.
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low dose inhaled fluticasone propionate versus oral Zafirlukast in the treatment of persistent asthma
The Journal of Allergy and Clinical Immunology, 2000Co-Authors: Eugene R. Bleecker, Chris Kalberg, Lisa D Edwards, Marty Johnson, M J Welch, S F Weinstein, Kathleen RickardAbstract:Abstract Background: Few studies have compared the efficacy of inhaled corticosteroids and leukotriene modifiers for the treatment of persistent asthma. Objective: Our purpose was to compare the efficacy of a low dose of inhaled fluticasone propionate (FP) with that of oral Zafirlukast in the treatment of persistent asthma previously treated with short-acting β 2 -agonists alone. Methods: A 12-week, randomized, double-blind, double-dummy, multicenter study was conducted in 451 patients aged 12 years and older with asthma who were symptomatic on short-acting β 2 -agonists alone. After an 8- to 14-day run-in period, patients were randomized to treatment with FP 88 μg twice daily or Zafirlukast 20 mg twice daily. Results: Treatment with FP was more effective than treatment with Zafirlukast in increasing morning FEV 1 (by 0.42 L vs 0.20 L over baseline, P P P 1 were noted after the first observation (week 4) and in morning and evening peak expiratory flow by week 2. Mean change in percentage of symptom-free days was greater with FP than with Zafirlukast (28.5% of days vs 15.6% of days, P P P P Conclusion: The clinical effectiveness of a low dose of FP as first-line therapy in patients with persistent asthma who are symptomatic on β 2 -agonists alone is superior to that of Zafirlukast. (J Allergy Clin Immunol 2000;105:1123-9.)
Chris Kalberg - One of the best experts on this subject based on the ideXlab platform.
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A comparison of short-term treatment with inhaled fluticasone propionate and Zafirlukast for patients with persistent asthma
The American journal of medicine, 2001Co-Authors: Robert A. Nathan, Eugene R. Bleecker, Chris KalbergAbstract:Abstract Purpose To compare the short-term efficacy and safety of low-dose fluticasone propionate with that of oral Zafirlukast therapy for patients previously treated with beta-2-agonists alone, and to evaluate the potential therapeutic benefit of switching from Zafirlukast to a low-dose inhaled corticosteroid. Subjects and methods This study consisted of a 4-week randomized, double-blind treatment period followed by a 4-week open-label period. Two hundred ninety-four patients ≥12 years old with asthma previously uncontrolled with beta-2-agonists alone were randomly assigned to treatment with low-dose inhaled fluticasone (88 μg twice daily) or oral Zafirlukast (20 mg twice daily). After 4 weeks, all patients discontinued their double-blind therapy and received open-label fluticasone (88 μg twice daily). Outcomes included pulmonary function, asthma symptoms, albuterol use, asthma exacerbations, and adverse events. Results During the double-blind treatment period, fluticasone patients had significantly greater improvements in morning peak flow (29.3 L/min vs. 18.3 L/min), percentage of symptom-free days (19.8% vs. 11.6%), and daily albuterol use (−1.8 puffs per day vs. −1.1 puffs per day) compared with Zafirlukast patients ( P ≤0.025, each comparison). During the open-label treatment period, patients switched from Zafirlukast to fluticasone experienced additional improvements in morning peak flow (17.2 L/min), evening peak flow (13.6 L/min), and FEV 1 (0.11 liter) and daily albuterol use (−0.9 puffs daily) compared with values obtained at the end of the double-blind treatment period ( P ≤0.001, each comparison). Conclusion Low-dose fluticasone was more effective than Zafirlukast in improving pulmonary function and symptoms in patients with persistent asthma. In addition, switching patients from Zafirlukast to fluticasone further improved clinical outcomes.
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cost efficacy analysis of fluticasone propionate versus Zafirlukast in patients with persistent asthma
PharmacoEconomics, 2001Co-Authors: Rogelio Menendez, Chris Kalberg, Lisa D Edwards, Richard H Stanford, Kathleen RickardAbstract:Objective: To compare the relative value of an inhaled corticosteroid, fluticasone propionate 88μg twice daily, versus an oral leukotriene receptor antagonist, Zafirlukast 20mg twice daily, in patients with persistent asthma currently receiving short acting β2-agonists alone. Study design: A cost-efficacy analysis using resource utilisation and clinical data obtained prospectively from a multicentre, randomised, double-blind, double-dummy, placebo-controlled 12-week clinical trial conducted in the US. Perspective: Third-party payor. Patients and methods: A total of 451 corticosteroid-naive patients with persistent asthma were treated with either fluticasone propionate 88μg twice daily or Zafirlukast 20mg twice daily. All patients were given salbutamol (albuterol) to be used as rescue medication. Data were examined using intent-to-treat analysis. Results: Mean daily per person cost-efficacy ratios using improvement in forced expiratory volume in 1 second (FEV1) [≥12% increase from baseline] were $US3.47 for fluticasone propionate compared with $US7.81 for Zafirlukast (1999 values). The mean daily per person cost-efficacy ratios for symptom-free days obtained were $US5.51 for fluticasone propionate compared with $US14.98 for Zafirlukast. These cost-efficacy ratios remained in favour of fluticasone propionate after a robust sensitivity analysis. Conclusions: Treatment with fluticasone propionate 88μg twice daily was the most cost effective treatment compared with Zafirlukast 20mg twice daily in this 12-week clinical trial. This analysis supports the use of fluticasone propionate 88μg twice daily as first-line treatment in patients with persistent asthma previously treated with short-acting β2-agonist alone.
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low dose inhaled fluticasone propionate versus oral Zafirlukast in the treatment of persistent asthma
The Journal of Allergy and Clinical Immunology, 2000Co-Authors: Eugene R. Bleecker, Chris Kalberg, Lisa D Edwards, Marty Johnson, M J Welch, S F Weinstein, Kathleen RickardAbstract:Abstract Background: Few studies have compared the efficacy of inhaled corticosteroids and leukotriene modifiers for the treatment of persistent asthma. Objective: Our purpose was to compare the efficacy of a low dose of inhaled fluticasone propionate (FP) with that of oral Zafirlukast in the treatment of persistent asthma previously treated with short-acting β 2 -agonists alone. Methods: A 12-week, randomized, double-blind, double-dummy, multicenter study was conducted in 451 patients aged 12 years and older with asthma who were symptomatic on short-acting β 2 -agonists alone. After an 8- to 14-day run-in period, patients were randomized to treatment with FP 88 μg twice daily or Zafirlukast 20 mg twice daily. Results: Treatment with FP was more effective than treatment with Zafirlukast in increasing morning FEV 1 (by 0.42 L vs 0.20 L over baseline, P P P 1 were noted after the first observation (week 4) and in morning and evening peak expiratory flow by week 2. Mean change in percentage of symptom-free days was greater with FP than with Zafirlukast (28.5% of days vs 15.6% of days, P P P P Conclusion: The clinical effectiveness of a low dose of FP as first-line therapy in patients with persistent asthma who are symptomatic on β 2 -agonists alone is superior to that of Zafirlukast. (J Allergy Clin Immunol 2000;105:1123-9.)
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Comparison of inhaled salmeterol and oral Zafirlukast in patients with asthma
The Journal of allergy and clinical immunology, 1999Co-Authors: W Busse, Chris Kalberg, H. Nelson, James D. Wolfe, Steven W. Yancey, Kathleen RickardAbstract:Abstract Background: Salmeterol, a long-acting β 2 -agonist, and Zafirlukast, a leukotriene receptor antagonist, are both indicated for the treatment of asthma in adolescent and adult patients. Objective: We sought to compare the effect of 4 weeks of treatment with inhaled salmeterol xinafoate versus oral Zafirlukast in the treatment of persistent asthma. Methods: This was a randomized, double-blind, double-dummy, parallel-group, multicenter clinical trial. Patients, over 80% of whom were on a concurrent inhaled corticosteroid regimen, were treated for 4 weeks with either inhaled salmeterol xinafoate 42 μg twice daily administered by means of a metered-dose inhaler or oral Zafirlukast 20 mg twice daily. The primary efficacy measure was morning peak expiratory flow (PEF); secondary efficacy measures included evening PEF, asthma symptom scores, supplemental albuterol use, nighttime awakenings, sleep symptoms, asthma exacerbations, and FEV 1 . Results: Both inhaled salmeterol and oral Zafirlukast resulted in within-group improvements from baseline in measures of pulmonary function, asthma symptoms, and supplemental albuterol use. Salmeterol treatment resulted in significantly greater improvements from baseline compared with Zafirlukast for most efficacy measurements, including morning PEF (29.6 vs 13.0 L/min; P ≤ .001), percentage of symptom-free days (22.4% vs 8.8%; P ≤ .001), and percentage of days and nights with no supplemental albuterol use (30.5% vs 11.3%; P ≤ .001). There were no differences in safety profiles as assessed by adverse event monitoring. Conclusion: In patients with persistent asthma, most of whom were concurrently using inhaled corticosteroids, treatment with inhaled salmeterol provided significantly greater improvement than oral Zafirlukast in overall asthma control over the 4-week treatment period. (J Allergy Clin Immunol 1999;103:1075-80.)
Catherine M. Bonuccelli - One of the best experts on this subject based on the ideXlab platform.
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Zafirlukast treatment for acute asthma evaluation in a randomized double blind multicenter trial
Chest, 2004Co-Authors: Robert Silverman, Catherine M. Bonuccelli, Phillip E. Korenblat, Christopher J. Miller, Richard M Nowak, Emil Skobeloff, Yusong Chen, Steven G SimonsonAbstract:Context: Acute asthma causes nearly 2 million hospital emergency department (ED) visits in the United States annually, and hospitalization after an ED visit and relapse after ED discharge are common. Objective: To evaluate the adding of therapy with Zafirlukast to standardized care for patients with acute asthma in the ED and a 28-day follow-up period. Design and patients: A total of 641 patients presenting to the ED with acute asthma were randomized to receive either single-dose Zafirlukast, 160 mg (Z160) [162 patients], Zafirlukast, 20 mg (Z20) [158 patients]), or placebo (321 patients) as adjunct treatment to standard care in this double-blind, multicenter trial. Assessments, including spirometry and symptom scores, were obtained before each albuterol treatment and at 4 h. Patients who were discharged from the ED after 4 h continued outpatient therapy over a 28-day period and received either Z20 bid (276 patients) or placebo (270 patients) in addition to prednisone, albuterol, and their previous asthma medications. FEV1 was measured at clinic visits on days 10 and 28. Patients recorded outpatient clinical data twice daily on a home diary card. Main outcome measures: the effect of Zafirlukast on relapse after ED discharge. Other assessments were the rate of extended care (ie, ED stay for > 4 h or hospitalization), FEV1, and symptoms. Results: At the end of the outpatient period, 65 of 276 patients (23.6%) treated with Zafirlukast and 78 of 270 patients (28.9%) treated with placebo relapsed (p = 0.047; absolute reduction, 5.3%; relative reduction, 18.3%). At the end of the ED period, 16 of 162 patients (9.9%) treated with Z160, 26 of 158 patients (16.5%) treated with Z20, and 48 of 321 patients (15.0%) treated with placebo required extended care (p = 0.052; absolute reduction with Z160 compared to placebo, 5.1%; relative reduction, 34%). These findings were supported by a significant improvement in FEV1 and dyspnea in the ED with the use of Z160 therapy, and by greater improvement in FEV1 and symptoms during the outpatient period for patients treated with Z20. Conclusions: When added to standardized care, therapy with Z20 bid reduced the risk of relapse compared with placebo over a 28-day treatment period. One dose of Z160 in the ED also reduced the rate of extended care.
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Effectiveness and tolerability of Zafirlukast for the treatment of asthma in children
Clinical therapeutics, 2000Co-Authors: David S Pearlman, Kathy L. Lampl, Paul J. Dowling, Christopher J. Miller, Catherine M. BonuccelliAbstract:Abstract Objective This study was undertaken to examine the dose-response relationship of Zafirlukast (5 to 40 mg BID) and to assess the efficacy and tolerability of the 10-mg BID dose in school-aged children with mild to moderate asthma. Background The efficacy and tolerability of Zafirlukast, an oral leukotriene-receptor antagonist, has been demonstrated in adolescents and adults aged ≥12 years. Methods Data from 2 placebo-controlled, parallel-group, multicenter trials (trial 1, 4-week double-blind; trial 2, 6-week double-blind) were integrated. Children aged 5 to 11 years were randomly assigned to receive Zafirlukast 5 mg BID (n = 99), 10 mg BID (n = 205), 20 mg BID (n = 105), 40 mg BID (n = 99), or placebo (n = 206). The primary outcome was change from baseline in forced expiratory volume in 1 second (FEV 1 ) expressed as percent of predicted normal. Secondary outcomes were FEV 1 (L), morning and evening peak expiratory flow, peak flow variability, short-acting beta 2 -agonist use, asthma episode score, and nights awakened by asthma. Results Mean baseline FEV 1 was 76.5% of predicted. The greatest improvements were generally seen with Zafirlukast 5 mg BID or 10 mg BID, with no additional clinically significant benefits seen at higher doses. The pooled data analysis showed that 10 mg BID compared with placebo significantly improved ( P P = 0.009) (mean difference from placebo at end point=−0.81 night/wk). All Zafirlukast doses were well tolerated and had tolerability profiles that were clinically indistinguishable from placebo. Conclusion These results support the effectiveness and tolerability of the 10-mg BID dose of Zafirlukast for the prophylaxis and chronic treatment of mild to moderate asthma in children.
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the leukotriene d4 receptor antagonist Zafirlukast attenuates exercise induced bronchoconstriction in children
The Journal of Pediatrics, 1999Co-Authors: David S Pearlman, Catherine M. Bonuccelli, Nancy K Ostrom, Edwin A Bronsky, Laura A HanbyAbstract:Abstract Objective: To determine the effects of Zafirlukast on exercise-induced bronchoconstriction in children. Study design: Exercise challenges were done 4 hours after single oral doses of Zafirlukast or placebo were administered in asthmatic children (6 to 14 years) treated with β2 -agonists alone. Subjects randomized to treatment had a ≥20% decrease in forced expiratory volume in 1 second (FEV1 ) after a screening challenge. In a randomized, double-blind, 3-way, crossover design, group 1 (n = 20) received placebo and 5 and 20 mg Zafirlukast, and group 2 (n = 19) received placebo and 10 and 40 mg Zafirlukast. Maximal percentage fall in FEV1 , area under the curve, and time to recovery of FEV1 to within 5% of baseline after the challenge were compared with analysis of variance. Results: Mean values for maximal fall in FEV1 ranged from –8.7% ± 1.7% to –11.1% ± 1.9% after Zafirlukast compared with –17.1% ± 1.8% and –16.3% ± 1.9% after placebo. Differences from placebo for fall in FEV1 and area under the curve were significant (P ≤ .05) after 5, 20, and 40 mg Zafirlukast and approached significance (P ≤ .08) after 10 mg Zafirlukast. After all Zafirlukast doses, recovery times (means of 5 to 7 minutes) decreased significantly (P ≤ .05) and by approximately half compared with placebo (11 and 14 minutes). Safety assessments did not differ among treatments. Conclusion: Four hours after dosing, Zafirlukast attenuated exercise-induced bronchoconstriction in children. (J Pediatr 1999;134:273-9)
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Therapeutic Effect of Zafirlukast as Monotherapy in Steroid-Naive Patients With Severe Persistent Asthma
Chest, 1999Co-Authors: James P. Kemp, Margaret C. Minkwitz, Catherine M. Bonuccelli, Marshelle S. WarrenAbstract:Study objectives We evaluated the efficacy of the leukotriene receptor antagonist Zafirlukast (Accolate ® ), 20 mg twice daily, as monotherapy in patients with severe persistent asthma (defined by an FEV 1 Design Data were analyzed from a subgroup of 261 steroid-naive patients (Zafirlukast, n = 149; placebo, n = 112) from four randomized, double-blind, placebo-controlled, 13-week trials with similar experimental designs, entry criteria, and clinical assessments. Patients These patients were mostly men (57%) older than 30 years (56%) with pulmonary obstruction, ie , FEV 1 /FVC ratio 1 after inhaled bronchodilator use. Results At end point, patients who received Zafirlukast monotherapy had significant (p 1 , morning and evening peak expiratory flow (PEF), daytime asthma symptoms, nighttime awakenings, and β 2 -agonist use. A stratified analysis based on the FEV 1 /FVC ratio showed an interaction between treatment and the amount of airflow obstruction for nighttime awakenings and mornings with asthma. Moreover, 37% of patients in both treatment groups had PEF variability ≥ 20% (an indirect measure of airway inflammation). Zafirlukast patients with PEF variability≥ 20% had increases from baseline in the morning and evening PEF of approximately 40 and 11 L/min, respectively. For patients who take Zafirlukast and who have a PEF variability of Conclusion Patients with severe persistent asthma who received Zafirlukast as monotherapy had clinically significant improvements across all efficacy measures compared with placebo and significant reductions in PEF variability.
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An evaluation of Zafirlukast in the treatment of asthma with exploratory subset analyses
Journal of Allergy and Clinical Immunology, 1999Co-Authors: D P Tashkin, Margaret C. Minkwitz, W C Howland, S G Simonson, Robert A. Nathan, Catherine M. BonuccelliAbstract:Abstract Background: Consensus asthma guidelines recommend antileukotriene agents as alternative therapy to existing anti-inflammatory medications; however, the full therapeutic potential of these medications has not yet been determined. Objective: The purpose of this study was to assess the efficacy and safety of the oral leukotriene receptor antagonist Zafirlukast (20 mg twice daily) in subgroups of patients who have asthma with the use of integrated data from four 13-week trials. Methods: The trials had comparable designs, entry criteria, and clinical assessments. Patient subgroups were characterized by demographic and baseline asthma characteristics. Analysis of covariance models were tested for overall treatment effect and for interactions between treatment and subgroup characteristics. Results: Patients with mild-to-moderate asthma (12 to 76 years old) who were treated with albuterol alone were randomized (n Z = 879; n P = 605) and included in subset analyses. Significant overall treatment effects, favoring Zafirlukast, were noted for measures of daytime and nighttime symptoms, β 2 -agonist use, and pulmonary function ( P 2 -agonist use ( P P 2 -agonist use (>8 puffs/day) and with greater baseline peak flow variability (≥20%) and baseline airflow obstruction (FEV 1 /forced vital capacity ratio, P Conclusions: Exploratory subset analyses showed that Zafirlukast is similarly efficacious in patients with asthma who have differing demographic characteristics and degrees of subjective symptoms. Additionally, Zafirlukast appears to be incrementally beneficial in patients with more moderate disease, defined by a greater requirement for as-needed rescue medication and more abnormal pulmonary function at baseline. Over 13 weeks, Zafirlukast was well tolerated and demonstrated a safety profile clinically indistinguishable from placebo. (J Allergy Clin Immunol 1999;103:246-54.)
Richard H Stanford - One of the best experts on this subject based on the ideXlab platform.
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economic impact of asthma therapy with fluticasone propionate montelukast or Zafirlukast in a managed care population
Pharmacotherapy, 2002Co-Authors: Dev S Pathak, Anne E Davis, Richard H StanfordAbstract:Study Objective. To compare asthma-related health care expenditures among patients newly prescribed fluticasone propionate 44 or 110 μg, montelukast 5 or 10 mg, or Zafirlukast 20 mg. Design. Retrospective cohort analysis of medical and pharmacy claims. Setting. University-affiliated health outcomes research center. Patients. Seven hundred eighty-one patients (aged ≥ 4 yrs) with asthma treated with controller therapy for 9 months (postindex period), with no claim for an inhaled corticosteroid or leukotriene modifier in the previous 9 months (preindex period). Intervention. Asthma-related medical and pharmacy data from insurance claims of four managed care plans (two Northeastern, one Midwestern, and one Western) were tabulated over the pre- and postindex periods. Measurements and Main Results. Numbers of patients identified were 284 beginning fluticasone propionate; 302, montelukast; and 195, Zafirlukast. Fluticasone propionate treatment was associated with significantly (p<0.001) lower risk-adjusted asthma-related charges compared with montelukast and Zafirlukast treatment: $528, $967, and $1359, respectively. In this cohort, fluticasone propionate also was associated with fewer hospitalizations, less need for additional controller agents, and longer maintenance on the index drug compared with montelukast and Zafirlukast. Conclusions. Based on these real-world data, as well as established national and international asthma guidelines, consideration should be given to inhaled corticosteroid therapy, particularly fluticasone propionate, for first-line, long-term effective management of asthma.
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cost efficacy analysis of fluticasone propionate versus Zafirlukast in patients with persistent asthma
PharmacoEconomics, 2001Co-Authors: Rogelio Menendez, Chris Kalberg, Lisa D Edwards, Richard H Stanford, Kathleen RickardAbstract:Objective: To compare the relative value of an inhaled corticosteroid, fluticasone propionate 88μg twice daily, versus an oral leukotriene receptor antagonist, Zafirlukast 20mg twice daily, in patients with persistent asthma currently receiving short acting β2-agonists alone. Study design: A cost-efficacy analysis using resource utilisation and clinical data obtained prospectively from a multicentre, randomised, double-blind, double-dummy, placebo-controlled 12-week clinical trial conducted in the US. Perspective: Third-party payor. Patients and methods: A total of 451 corticosteroid-naive patients with persistent asthma were treated with either fluticasone propionate 88μg twice daily or Zafirlukast 20mg twice daily. All patients were given salbutamol (albuterol) to be used as rescue medication. Data were examined using intent-to-treat analysis. Results: Mean daily per person cost-efficacy ratios using improvement in forced expiratory volume in 1 second (FEV1) [≥12% increase from baseline] were $US3.47 for fluticasone propionate compared with $US7.81 for Zafirlukast (1999 values). The mean daily per person cost-efficacy ratios for symptom-free days obtained were $US5.51 for fluticasone propionate compared with $US14.98 for Zafirlukast. These cost-efficacy ratios remained in favour of fluticasone propionate after a robust sensitivity analysis. Conclusions: Treatment with fluticasone propionate 88μg twice daily was the most cost effective treatment compared with Zafirlukast 20mg twice daily in this 12-week clinical trial. This analysis supports the use of fluticasone propionate 88μg twice daily as first-line treatment in patients with persistent asthma previously treated with short-acting β2-agonist alone.
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fluticasone propionate versus Zafirlukast effect in patients previously receiving inhaled corticosteroid therapy
Annals of Allergy Asthma & Immunology, 2000Co-Authors: Kenneth T Kim, Sharon Srebro, Lisa D Edwards, Elliot J Ginchansky, Bruce Friedman, Pamela J Pepsin, Richard H Stanford, Kathleen RickardAbstract:Background The use of inhaled corticosteroids compared with leukotriene modifying drugs in the treatment of persistent asthma has not been extensively studied. Objective To compare the efficacy and safety of a low dose of fluticasone propionate (FP) and Zafirlukast in patients previously maintained on inhaled corticosteroids. Methods Patients (≥12 years old; FEV 1 = 60% to 85% of predicted) with persistent asthma who were previously treated with low doses of triamcinolone acetonide (TAA) 400 to 800 μg/day or beclomethasone dipropionate (BDP) 168 to 336 μg/day were randomized to treatment with FP aerosol 88 μg BID (FP, n=221) or Zafirlukast 20 mg BID (n = 216) over 6 weeks. Results Treatment with FP significantly increased the mean change at endpoint (the last post-baseline observation) in FEV 1 (0.22L versus 0.03L, P P = .004), evening PEF (16.7 versus 2.6 L/min, P = .002), the percentage of symptom-free days (16.2 versus 7.1%, P = .007), and the percentage of rescue-free days (23.4 versus 9.3%, P P P P P P P = .035). Patients in the Zafirlukast group were significantly more likely to be withdrawn due to lack of efficacy ( P Conclusion Switching patients from low doses of inhaled corticosteroids to a lower total microgram dose of FP improves pulmonary function, asthma symptoms, and quality of life, while switching to the leukotriene receptor antagonist Zafirlukast may result in worsening of asthma control. This was indicated by the significant number of Zafirlukast-treated patients who were dropped from the study due to lack of efficacy within 6 weeks of discontinuing inhaled corticosteroids.
