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Theodore F Reiss - One of the best experts on this subject based on the ideXlab platform.

  • onset and duration of protection against exercise induced bronchoconstriction by a single oral dose of Montelukast
    Annals of Allergy Asthma & Immunology, 2006
    Co-Authors: David S Pearlman, Janet Van Adelsberg, George Philip, Stephen A Tilles, William W Busse, Leslie Hendeles, T Loeys, S B Dass, Theodore F Reiss
    Abstract:

    Background Leukotriene modifiers have been shown to protect against exercise-induced bronchoconstriction (EIB) with repeated, chronic dosing. Objective To study the onset and duration of protection against EIB after a single dose of Montelukast, a leukotriene receptor antagonist. Methods In this randomized, crossover, double-blind study, 51 adult asthma patients with EIB (≥20% postexercise decrease in forced expiratory volume in 1 second [FEV 1 ]) received a single oral dose of Montelukast (10 mg), or placebo followed by exercise challenge 2, 12, and 24 hours after dosing. The primary end point was maximum percentage decrease in FEV 1 from preexercise baseline during 60 minutes after the 2-hour challenge. Results At 2, 12, and 24 hours after dosing, the maximum decrease in FEV 1 was 10.8% ± 7.9%, 8.4% ± 7.5%, and 8.3% ± 7.3% for Montelukast and 22.3% ± 13.1%, 16.1% ± 10.2%, and 16.9% ± 11.7% for placebo, respectively ( P ≤ .001 at each time point). Postexercise recovery was quicker with Montelukast than with placebo ( P ≤ .001); mean (95% confidence interval) differences were −26.8 minutes (−35.1 to −18.4 minutes), −16.0 minutes (−22.9 to −9.2 minutes), and −17.4 minutes (−24.9 to −9.9 minutes) at the 3 time points, respectively. At all time points, area under the curve for percentage decrease in FEV 1 during 60 minutes after exercise was smaller after Montelukast ( P ≤ .001); Montelukast protected more patients against EIB ( P ≤ .001). Fewer patients required postexercise β-agonist rescue at 2 hours after dosing with Montelukast ( P = .03). Conclusion Montelukast provided significant protection against EIB as soon as 2 hours after a single oral dose, with persistent benefit up to 24 hours.

  • clinical safety and tolerability of Montelukast a leukotriene receptor antagonist in controlled clinical trials in patients aged 6 years
    Clinical & Experimental Allergy, 2001
    Co-Authors: W W Storms, Gertrude Noonan, Barbara Knorr, T Michele, G Shapiro, Ji Zhang, S Shingo, Theodore F Reiss
    Abstract:

    Objective Montelukast is a leukotriene receptor antagonist administered orally once daily for treatment of chronic asthma in adults and children. A comprehensive analysis of safety data from double-blind, randomized, placebo-controlled trials with Montelukast has not been previously reported. Patients and methods A pooled analysis of safety data from 11 multicentre, randomized, controlled Montelukast Phase IIb and III trials and five long-term extension studies was performed. A total of 3386 adult patients (aged 15-85 years) and 336 paediatric patients (aged 6-14 years) were enrolled in the trials; 2031 adults received Montelukast for up to 4.1 years, and 257 children received Montelukast for up to 1.8 years. Summary statistics comparing incidences of adverse events among treatment groups were calculated. Results The overall incidence of clinical and laboratory adverse events among Montelukast-treated patients, both adult and paediatric, was similar to that among patients receiving placebo. There were no clinically relevant differences in individual adverse events, including infectious upper respiratory conditions and transaminase elevations, between Montelukast and placebo groups. Discontinuations due to adverse events occurred with similar frequencies during placebo, Montelukast and inhaled beclomethasone therapy. No dose-related adverse effects of Montelukast were observed in adults treated with dosages as high as 200 mg per day (20 times the recommended dose) for 5 months. This tolerability profile Montelukast observed in clinical trials has been generally reflected in the post-marketing safety experience seen to date. Conclusion These data indicate a tolerability profile for Montelukast similar to placebo during both short-term and long-term administration, even at doses substantially higher than the recommended clinical dose of 10 mg once daily for adults and 5 mg once daily for children aged 6-14 years.

  • randomised placebo controlled trial of effect of a leukotriene receptor antagonist Montelukast on tapering inhaled corticosteroids in asthmatic patients
    BMJ, 1999
    Co-Authors: Claesgoran Lofdahl, Beth C Seidenberg, Theodore F Reiss, Albert F. Finn, Jonathan A Leff, Elliot Israel, Michael J Noonan, Thomas P Capizzi, Sudeep Kundu, Philippe Godard
    Abstract:

    Abstract Objective: To determine the ability of Montelukast, a leukotriene receptor antagonist, to allow tapering of inhaled corticosteroids in clinically stable asthmatic patients. Design: Double blind, randomised, placebo controlled, parallel group study. After a single blind placebo run in period, during which (at most) two inhaled corticosteroids dose decreases occurred, qualifying, clinically stable patients were allocated randomly to receive Montelukast (10 mg tablet) or matching placebo once daily at bedtime for up to 12 weeks. Setting: 23 academic asthma centres in United States, Canada, and Europe. Participants: 226 clinically stable patients with chronic asthma receiving high doses of inhaled corticosteroids (113 randomised to Montelukast and 113 to placebo). Interventions: Every 2 weeks, the inhaled corticosteroids dose was tapered, maintained, or increased (rescue) based on a standardised clinical score. Main outcome measures: Last tolerated dose of inhaled corticosteroids. Results: Compared with placebo, Montelukast allowed significant (P=0.046) reduction in the inhaled corticosteroid dose (Montelukast 47% v placebo 30%; least square mean difference 17.6%, 95% confidence interval 0.3 to 34.8). Fewer patients on Montelukast (18 (16%) v 34 (30%) placebo, P=0.01) required discontinuation because of failed rescue. Conclusions: Montelukast reduces the need for inhaled corticosteroids among patients requiring moderate to high doses of corticosteroid to maintain asthma control. Key messages Leukotriene receptor antagonists have complementary action to inhaled corticosteroids in asthma Many patients receive higher doses of inhaled corticosteroids than clinically required In this placebo controlled trial, Montelukast allowed significant reduction of inhaled corticosteroid doses Fewer patients receiving Montelukast had failed rescue than patients receiving placebo

  • randomised placebo controlled trial of effect of a leukotriene receptor antagonist Montelukast on tapering inhaled corticosteroids in asthmatic patients
    BMJ, 1999
    Co-Authors: Claesgoran Lofdahl, Beth C Seidenberg, Theodore F Reiss, Albert F. Finn, Jonathan A Leff, Elliot Israel, Michael J Noonan, Thomas P Capizzi, Sudeep Kundu, Philippe Godard
    Abstract:

    OBJECTIVE: To determine the ability of Montelukast, a leukotriene receptor antagonist, to allow tapering of inhaled corticosteroids in clinically stable asthmatic patients. DESIGN: Double blind, randomised, placebo controlled, parallel group study. After a single blind placebo run in period, during which (at most) two inhaled corticosteroids dose decreases occurred, qualifying, clinically stable patients were allocated randomly to receive Montelukast (10 mg tablet) or matching placebo once daily at bedtime for up to 12 weeks. SETTING: 23 academic asthma centres in United States, Canada, and Europe. PARTICIPANTS: 226 clinically stable patients with chronic asthma receiving high doses of inhaled corticosteroids (113 randomised to Montelukast and 113 to placebo). INTERVENTIONS: Every 2 weeks, the inhaled corticosteroids dose was tapered, maintained, or increased (rescue) based on a standardised clinical score. MAIN OUTCOME MEASURES: Last tolerated dose of inhaled corticosteroids. RESULTS: Compared with placebo, Montelukast allowed significant (P=0. 046) reduction in the inhaled corticosteroid dose (Montelukast 47% v placebo 30%; least square mean difference 17.6%, 95% confidence interval 0.3 to 34.8). Fewer patients on Montelukast (18 (16%) v 34 (30%) placebo, P=0.01) required discontinuation because of failed rescue. CONCLUSIONS: Montelukast reduces the need for inhaled corticosteroids among patients requiring moderate to high doses of corticosteroid to maintain asthma control.

  • Montelukast once daily inhibits exercise induced bronchoconstriction in 6 to 14 year old children with asthma
    The Journal of Pediatrics, 1998
    Co-Authors: James P Kemp, Beth C Seidenberg, Theodore F Reiss, Ha H. Nguyen, Robert J Dockhorn, Gail G Shapiro, Barbara Knorr
    Abstract:

    Abstract Objective: To determine whether Montelukast, a leukotriene receptor antagonist, attenuates exercise-induced bronchoconstriction (EIB) in 6- to 14-year-old children with asthma. Study design: Double-blind, multicenter, 2-period crossover study. Children (n = 27) with forced expiratory volume in 1 second (FEV 1 ) ≥70% of the predicted value and a fall in FEV 1 ≥ 20% after exercise on 2 occasions. Patients received Montelukast (5-mg chewable tablet) or placebo once daily in the evening for 2 days in crossover fashion (at least 4 days between treatment periods). Standardized exercise challenges were performed 20 to 24 hours after the last dose in each period. End points included area above the postexercise percent fall in FEV 1 versus time curve (AAC 0-60min ), maximum percent fall in FEV 1 from pre-exercise baseline, and time to recovery of FEV 1 to within 5% of pre-exercise baseline. Results: Montelukast significantly reduced AAC 0-60min (265 vs 590 % · min for Montelukast and placebo, respectively, P ≤ .05; ~59% protection relative to placebo) and the maximum percent fall (18% vs 26% for Montelukast and placebo, respectively, P ≤ .05). Montelukast treatment resulted in a shorter time to recovery (18 vs 28 minutes for Montelukast and placebo, respectively, P = .079). Conclusions: Montelukast attenuates EIB at the end of the dosing interval in 6- to 14-year-old children with asthma. (J Pediatr 1998;133:424-8)

Beth C Seidenberg - One of the best experts on this subject based on the ideXlab platform.

  • Montelukast a leukotriene receptor antagonist in combination with loratadine a histamine receptor antagonist in the treatment of chronic asthma
    JAMA Internal Medicine, 2000
    Co-Authors: Alise S Reicin, Steven F Weinstein, Iza Peszek, Lori Geissler, Albert F. Finn, Ha H. Nguyen, Richard H. White, Beth C Seidenberg
    Abstract:

    Background Montelukast sodium, a potent, oral, specific leukotriene-receptor antagonist, has demonstrated clinical efficacy in the treatment of chronic asthma. Loratadine, a selective histamine type 1 (H 1 )-receptor antagonist, has demonstrated antiallergic properties. Leukotriene-receptor antagonists given concomitantly with H 1 -receptor antagonists have been shown to have additive effects in the prevention of bronchospasm in antigen-challenge models. Objective To determine whether Montelukast plus loratadine provides improved efficacy to Montelukast alone in the treatment of chronic asthma. Methods The efficacy of Montelukast alone vs Montelukast-loratadine was studied in a 10-week, multicenter, randomized, double-blind, 2 × 2 crossover study. After a 2-week placebo run-in period, patients received Montelukast sodium (10 mg) plus loratadine (20 mg), or Montelukast sodium (10 mg) plus placebo once daily for 2 weeks. After a 2-week placebo washout period, patients were crossed over to receive 2 weeks of the other active treatment regimen, followed by another 2-week placebo washout period. Results Montelukast given concomitantly with loratadine caused significant improvement in percentage of change from baseline in forced expiratory volume in 1 second (FEV 1 ) compared with Montelukast alone (13.86% vs 9.72%; P = .001). The average additional effect of loratadine (least square mean difference in percentage of change from baseline in FEV 1 ) was 4.15% (95% confidence interval, 1.65%-6.65%). Key secondary end points (mean daily β-agonist use, daytime and nighttime symptom scores, morning and evening peak expiratory flow rate, and the Patient Global Evaluation) all showed significant improvement with Montelukast-loratadine ( P Conclusion Montelukast-loratadine significantly improved end points of asthma control during a 2-week treatment period.

  • randomised placebo controlled trial of effect of a leukotriene receptor antagonist Montelukast on tapering inhaled corticosteroids in asthmatic patients
    BMJ, 1999
    Co-Authors: Claesgoran Lofdahl, Beth C Seidenberg, Theodore F Reiss, Albert F. Finn, Jonathan A Leff, Elliot Israel, Michael J Noonan, Thomas P Capizzi, Sudeep Kundu, Philippe Godard
    Abstract:

    Abstract Objective: To determine the ability of Montelukast, a leukotriene receptor antagonist, to allow tapering of inhaled corticosteroids in clinically stable asthmatic patients. Design: Double blind, randomised, placebo controlled, parallel group study. After a single blind placebo run in period, during which (at most) two inhaled corticosteroids dose decreases occurred, qualifying, clinically stable patients were allocated randomly to receive Montelukast (10 mg tablet) or matching placebo once daily at bedtime for up to 12 weeks. Setting: 23 academic asthma centres in United States, Canada, and Europe. Participants: 226 clinically stable patients with chronic asthma receiving high doses of inhaled corticosteroids (113 randomised to Montelukast and 113 to placebo). Interventions: Every 2 weeks, the inhaled corticosteroids dose was tapered, maintained, or increased (rescue) based on a standardised clinical score. Main outcome measures: Last tolerated dose of inhaled corticosteroids. Results: Compared with placebo, Montelukast allowed significant (P=0.046) reduction in the inhaled corticosteroid dose (Montelukast 47% v placebo 30%; least square mean difference 17.6%, 95% confidence interval 0.3 to 34.8). Fewer patients on Montelukast (18 (16%) v 34 (30%) placebo, P=0.01) required discontinuation because of failed rescue. Conclusions: Montelukast reduces the need for inhaled corticosteroids among patients requiring moderate to high doses of corticosteroid to maintain asthma control. Key messages Leukotriene receptor antagonists have complementary action to inhaled corticosteroids in asthma Many patients receive higher doses of inhaled corticosteroids than clinically required In this placebo controlled trial, Montelukast allowed significant reduction of inhaled corticosteroid doses Fewer patients receiving Montelukast had failed rescue than patients receiving placebo

  • randomised placebo controlled trial of effect of a leukotriene receptor antagonist Montelukast on tapering inhaled corticosteroids in asthmatic patients
    BMJ, 1999
    Co-Authors: Claesgoran Lofdahl, Beth C Seidenberg, Theodore F Reiss, Albert F. Finn, Jonathan A Leff, Elliot Israel, Michael J Noonan, Thomas P Capizzi, Sudeep Kundu, Philippe Godard
    Abstract:

    OBJECTIVE: To determine the ability of Montelukast, a leukotriene receptor antagonist, to allow tapering of inhaled corticosteroids in clinically stable asthmatic patients. DESIGN: Double blind, randomised, placebo controlled, parallel group study. After a single blind placebo run in period, during which (at most) two inhaled corticosteroids dose decreases occurred, qualifying, clinically stable patients were allocated randomly to receive Montelukast (10 mg tablet) or matching placebo once daily at bedtime for up to 12 weeks. SETTING: 23 academic asthma centres in United States, Canada, and Europe. PARTICIPANTS: 226 clinically stable patients with chronic asthma receiving high doses of inhaled corticosteroids (113 randomised to Montelukast and 113 to placebo). INTERVENTIONS: Every 2 weeks, the inhaled corticosteroids dose was tapered, maintained, or increased (rescue) based on a standardised clinical score. MAIN OUTCOME MEASURES: Last tolerated dose of inhaled corticosteroids. RESULTS: Compared with placebo, Montelukast allowed significant (P=0. 046) reduction in the inhaled corticosteroid dose (Montelukast 47% v placebo 30%; least square mean difference 17.6%, 95% confidence interval 0.3 to 34.8). Fewer patients on Montelukast (18 (16%) v 34 (30%) placebo, P=0.01) required discontinuation because of failed rescue. CONCLUSIONS: Montelukast reduces the need for inhaled corticosteroids among patients requiring moderate to high doses of corticosteroid to maintain asthma control.

  • Montelukast once daily inhibits exercise induced bronchoconstriction in 6 to 14 year old children with asthma
    The Journal of Pediatrics, 1998
    Co-Authors: James P Kemp, Beth C Seidenberg, Theodore F Reiss, Ha H. Nguyen, Robert J Dockhorn, Gail G Shapiro, Barbara Knorr
    Abstract:

    Abstract Objective: To determine whether Montelukast, a leukotriene receptor antagonist, attenuates exercise-induced bronchoconstriction (EIB) in 6- to 14-year-old children with asthma. Study design: Double-blind, multicenter, 2-period crossover study. Children (n = 27) with forced expiratory volume in 1 second (FEV 1 ) ≥70% of the predicted value and a fall in FEV 1 ≥ 20% after exercise on 2 occasions. Patients received Montelukast (5-mg chewable tablet) or placebo once daily in the evening for 2 days in crossover fashion (at least 4 days between treatment periods). Standardized exercise challenges were performed 20 to 24 hours after the last dose in each period. End points included area above the postexercise percent fall in FEV 1 versus time curve (AAC 0-60min ), maximum percent fall in FEV 1 from pre-exercise baseline, and time to recovery of FEV 1 to within 5% of pre-exercise baseline. Results: Montelukast significantly reduced AAC 0-60min (265 vs 590 % · min for Montelukast and placebo, respectively, P ≤ .05; ~59% protection relative to placebo) and the maximum percent fall (18% vs 26% for Montelukast and placebo, respectively, P ≤ .05). Montelukast treatment resulted in a shorter time to recovery (18 vs 28 minutes for Montelukast and placebo, respectively, P = .079). Conclusions: Montelukast attenuates EIB at the end of the dosing interval in 6- to 14-year-old children with asthma. (J Pediatr 1998;133:424-8)

  • Montelukast once daily inhibits exercise induced bronchoconstriction in 6 to 14 year old children with asthma
    The Journal of Pediatrics, 1998
    Co-Authors: James P Kemp, Beth C Seidenberg, Theodore F Reiss, Ha H. Nguyen, Robert J Dockhorn, Gail G Shapiro, Barbara Knorr
    Abstract:

    Abstract Objective: To determine whether Montelukast, a leukotriene receptor antagonist, attenuates exercise-induced bronchoconstriction (EIB) in 6- to 14-year-old children with asthma. Study design: Double-blind, multicenter, 2-period crossover study. Children (n = 27) with forced expiratory volume in 1 second (FEV 1 ) ≥70% of the predicted value and a fall in FEV 1 ≥ 20% after exercise on 2 occasions. Patients received Montelukast (5-mg chewable tablet) or placebo once daily in the evening for 2 days in crossover fashion (at least 4 days between treatment periods). Standardized exercise challenges were performed 20 to 24 hours after the last dose in each period. End points included area above the postexercise percent fall in FEV 1 versus time curve (AAC 0-60min ), maximum percent fall in FEV 1 from pre-exercise baseline, and time to recovery of FEV 1 to within 5% of pre-exercise baseline. Results: Montelukast significantly reduced AAC 0-60min (265 vs 590 % · min for Montelukast and placebo, respectively, P ≤ .05; ~59% protection relative to placebo) and the maximum percent fall (18% vs 26% for Montelukast and placebo, respectively, P ≤ .05). Montelukast treatment resulted in a shorter time to recovery (18 vs 28 minutes for Montelukast and placebo, respectively, P = .079). Conclusions: Montelukast attenuates EIB at the end of the dosing interval in 6- to 14-year-old children with asthma. (J Pediatr 1998;133:424-8)

James P Kemp - One of the best experts on this subject based on the ideXlab platform.

  • oral Montelukast compared with inhaled salmeterol to prevent exercise induced bronchoconstriction a randomized double blind trial
    Annals of Internal Medicine, 2000
    Co-Authors: Jonathan M Edelman, James P Kemp, Jennifer A Turpin, Edwin A Bronsky, Jay Grossman, Asma F Ghannam, Paul Delucca, Glenn J Gormley, David S Pearlman
    Abstract:

    Background: Montelukast, an oral, once-daily leukotriene receptor antagonist, provides protection against exercise-induced bronchoconstriction. Objective: To evaluate the effect of 8 weeks of therapy with salmeterol aerosol or Montelukast on exercise-induced bronchoconstriction in adults with asthma. Design: 8-week multicenter, randomized, double-blind study. Setting: 17 asthma treatment centers in the United States. Patients: 191 adults with asthma who had documented exercise-induced bronchoconstriction. Intervention: Qualified patients were randomly assigned to double-blind treatment with Montelukast (10 mg once in the evening) or salmeterol (50 μg [2 puffs] twice daily). Measurements: Changes in pre-exercise and post-exercise challenge values; percentage inhibition in the maximal percentage decrease in FEV 1 ; the area above the FEV 1 -time curve; and time to recovery of FEV 1 at days 1 to 3, week 4, and week 8 of treatment. Results: By day 3, similar and statistically significant reductions in maximal percentage decrease in FEV 1 were seen with both therapies. Sustained improvement occurred in the Montelukast group at weeks 4 and 8; at these time points, the bronchoprotective effect of salmeterol decreased significantly. At week 8, the percentage inhibition in the maximal percentage decrease in FEV 1 was 57.2% in the Montelukast group and 33.0% in the salmeterol group (P = 0.002). By week 8, 67% of patients receiving Montelukast and 46% of patients receiving salmeterol had a maximal percentage decrease in FEV 1 of less than 20%. Conclusions: The bronchoprotective effect of Montelukast was maintained throughout 8 weeks of study. In contrast, significant loss of bronchoprotection at weeks 4 and 8 was seen with salmeterol. Long-term administration of Montelukast provided consistent inhibition of exercise-induced bronchoconstriction at the end of the 8-week dosing interval without tolerance.

  • oral Montelukast compared with inhaled salmeterol to prevent exercise induced bronchoconstriction a randomized double blind trial
    Annals of Internal Medicine, 2000
    Co-Authors: Jonathan M Edelman, James P Kemp, Jennifer A Turpin, Edwin A Bronsky, Jay Grossman, Asma F Ghannam, Paul Delucca, Glenn J Gormley, David S Pearlman
    Abstract:

    Background: Montelukast, an oral, once-daily leukotriene receptor antagonist, provides protection against exercise-induced bronchoconstriction. Objective: To evaluate the effect of 8 weeks of therapy with salmeterol aerosol or Montelukast on exercise-induced bronchoconstriction in adults with asthma. Design: 8-week multicenter, randomized, double-blind study. Setting: 17 asthma treatment centers in the United States. Patients: 191 adults with asthma who had documented exercise-induced bronchoconstriction. Intervention: Qualified patients were randomly assigned to double-blind treatment with Montelukast (10 mg once in the evening) or salmeterol (50 μg [2 puffs] twice daily). Measurements: Changes in pre-exercise and post-exercise challenge values; percentage inhibition in the maximal percentage decrease in FEV 1 ; the area above the FEV 1 -time curve; and time to recovery of FEV 1 at days 1 to 3, week 4, and week 8 of treatment. Results: By day 3, similar and statistically significant reductions in maximal percentage decrease in FEV 1 were seen with both therapies. Sustained improvement occurred in the Montelukast group at weeks 4 and 8; at these time points, the bronchoprotective effect of salmeterol decreased significantly. At week 8, the percentage inhibition in the maximal percentage decrease in FEV 1 was 57.2% in the Montelukast group and 33.0% in the salmeterol group (P = 0.002). By week 8, 67% of patients receiving Montelukast and 46% of patients receiving salmeterol had a maximal percentage decrease in FEV 1 of less than 20%. Conclusions: The bronchoprotective effect of Montelukast was maintained throughout 8 weeks of study. In contrast, significant loss of bronchoprotection at weeks 4 and 8 was seen with salmeterol. Long-term administration of Montelukast provided consistent inhibition of exercise-induced bronchoconstriction at the end of the 8-week dosing interval without tolerance.

  • Montelukast once daily inhibits exercise induced bronchoconstriction in 6 to 14 year old children with asthma
    The Journal of Pediatrics, 1998
    Co-Authors: James P Kemp, Beth C Seidenberg, Theodore F Reiss, Ha H. Nguyen, Robert J Dockhorn, Gail G Shapiro, Barbara Knorr
    Abstract:

    Abstract Objective: To determine whether Montelukast, a leukotriene receptor antagonist, attenuates exercise-induced bronchoconstriction (EIB) in 6- to 14-year-old children with asthma. Study design: Double-blind, multicenter, 2-period crossover study. Children (n = 27) with forced expiratory volume in 1 second (FEV 1 ) ≥70% of the predicted value and a fall in FEV 1 ≥ 20% after exercise on 2 occasions. Patients received Montelukast (5-mg chewable tablet) or placebo once daily in the evening for 2 days in crossover fashion (at least 4 days between treatment periods). Standardized exercise challenges were performed 20 to 24 hours after the last dose in each period. End points included area above the postexercise percent fall in FEV 1 versus time curve (AAC 0-60min ), maximum percent fall in FEV 1 from pre-exercise baseline, and time to recovery of FEV 1 to within 5% of pre-exercise baseline. Results: Montelukast significantly reduced AAC 0-60min (265 vs 590 % · min for Montelukast and placebo, respectively, P ≤ .05; ~59% protection relative to placebo) and the maximum percent fall (18% vs 26% for Montelukast and placebo, respectively, P ≤ .05). Montelukast treatment resulted in a shorter time to recovery (18 vs 28 minutes for Montelukast and placebo, respectively, P = .079). Conclusions: Montelukast attenuates EIB at the end of the dosing interval in 6- to 14-year-old children with asthma. (J Pediatr 1998;133:424-8)

  • Montelukast once daily inhibits exercise induced bronchoconstriction in 6 to 14 year old children with asthma
    The Journal of Pediatrics, 1998
    Co-Authors: James P Kemp, Beth C Seidenberg, Theodore F Reiss, Ha H. Nguyen, Robert J Dockhorn, Gail G Shapiro, Barbara Knorr
    Abstract:

    Abstract Objective: To determine whether Montelukast, a leukotriene receptor antagonist, attenuates exercise-induced bronchoconstriction (EIB) in 6- to 14-year-old children with asthma. Study design: Double-blind, multicenter, 2-period crossover study. Children (n = 27) with forced expiratory volume in 1 second (FEV 1 ) ≥70% of the predicted value and a fall in FEV 1 ≥ 20% after exercise on 2 occasions. Patients received Montelukast (5-mg chewable tablet) or placebo once daily in the evening for 2 days in crossover fashion (at least 4 days between treatment periods). Standardized exercise challenges were performed 20 to 24 hours after the last dose in each period. End points included area above the postexercise percent fall in FEV 1 versus time curve (AAC 0-60min ), maximum percent fall in FEV 1 from pre-exercise baseline, and time to recovery of FEV 1 to within 5% of pre-exercise baseline. Results: Montelukast significantly reduced AAC 0-60min (265 vs 590 % · min for Montelukast and placebo, respectively, P ≤ .05; ~59% protection relative to placebo) and the maximum percent fall (18% vs 26% for Montelukast and placebo, respectively, P ≤ .05). Montelukast treatment resulted in a shorter time to recovery (18 vs 28 minutes for Montelukast and placebo, respectively, P = .079). Conclusions: Montelukast attenuates EIB at the end of the dosing interval in 6- to 14-year-old children with asthma. (J Pediatr 1998;133:424-8)

  • dose related protection of exercise bronchoconstriction by Montelukast a cysteinyl leukotriene receptor antagonist at the end of a once daily dosing interval
    Clinical Pharmacology & Therapeutics, 1997
    Co-Authors: Edwin A Bronsky, Ji Zhang, James P Kemp, Debra Guerreiro, Theodore F Reiss
    Abstract:

    The dose-related protective effects of Montelukast, a potent and selective cysteinyl leukotriene-receptor antagonist, against exercise-induced bronchoconstriction were investigated in a five-period, randomized, incomplete-block, crossover study with Montelukast (0.4, 2, 10, 50 mg) and placebo. The study subjects were 27 nonsmoking, healthy stable patients with asthma (mean forced expiratory volume in 1 second [FEV1], 82.0% predicted) who demonstrated a ≥20% decrease in FEV1 while β-agonist was withheld for 6 hours before treadmill exercise. The standard exercise challenge was performed 20 to 24 hours, and again 32 to 36 hours, after the second of two once-daily doses. The effect of oral Montelukast on exercise was measured by the area above the postexercise percentage decrease in FEV1 versus time curve from 0 to 60 minutes [AUC(0–60)], the maximal percentage decrease in FEV1 after exercise, and time after maximal decrease to recovery of FEV1 to within 5% of the preexercise baseline. Twenty to 24 hours after administration, Montelukast caused dose-related protection, while providing similar protection against exercise-induced bronchoconstriction at the two highest doses. The AUC(0–60) values (mean ± SD) were 637 ± 898, 715 ± 870, 988 ± 1147, and 927 ± 968 min · % for 50, 10, 2, and 0.4 mg Montelukast, respectively, and 1193 ± 1097 min · % for placebo (p = 0.003). No important clinical effect was present 36 hours after dosing. Montelukast was generally well tolerated at all dose levels. In conclusion, Montelukast caused dose-related protection against exercise-induced bronchoconstriction at the end of a once-daily dosing interval. Protection against exercise-induced bronchoconstriction can be used to determine appropriate dose selection. Clinical Pharmacology & Therapeutics (1997) 62, 556–561; doi:

David S Pearlman - One of the best experts on this subject based on the ideXlab platform.

  • onset and duration of protection against exercise induced bronchoconstriction by a single oral dose of Montelukast
    Annals of Allergy Asthma & Immunology, 2006
    Co-Authors: David S Pearlman, Janet Van Adelsberg, George Philip, Stephen A Tilles, William W Busse, Leslie Hendeles, T Loeys, S B Dass, Theodore F Reiss
    Abstract:

    Background Leukotriene modifiers have been shown to protect against exercise-induced bronchoconstriction (EIB) with repeated, chronic dosing. Objective To study the onset and duration of protection against EIB after a single dose of Montelukast, a leukotriene receptor antagonist. Methods In this randomized, crossover, double-blind study, 51 adult asthma patients with EIB (≥20% postexercise decrease in forced expiratory volume in 1 second [FEV 1 ]) received a single oral dose of Montelukast (10 mg), or placebo followed by exercise challenge 2, 12, and 24 hours after dosing. The primary end point was maximum percentage decrease in FEV 1 from preexercise baseline during 60 minutes after the 2-hour challenge. Results At 2, 12, and 24 hours after dosing, the maximum decrease in FEV 1 was 10.8% ± 7.9%, 8.4% ± 7.5%, and 8.3% ± 7.3% for Montelukast and 22.3% ± 13.1%, 16.1% ± 10.2%, and 16.9% ± 11.7% for placebo, respectively ( P ≤ .001 at each time point). Postexercise recovery was quicker with Montelukast than with placebo ( P ≤ .001); mean (95% confidence interval) differences were −26.8 minutes (−35.1 to −18.4 minutes), −16.0 minutes (−22.9 to −9.2 minutes), and −17.4 minutes (−24.9 to −9.9 minutes) at the 3 time points, respectively. At all time points, area under the curve for percentage decrease in FEV 1 during 60 minutes after exercise was smaller after Montelukast ( P ≤ .001); Montelukast protected more patients against EIB ( P ≤ .001). Fewer patients required postexercise β-agonist rescue at 2 hours after dosing with Montelukast ( P = .03). Conclusion Montelukast provided significant protection against EIB as soon as 2 hours after a single oral dose, with persistent benefit up to 24 hours.

  • oral Montelukast compared with inhaled salmeterol to prevent exercise induced bronchoconstriction a randomized double blind trial
    Annals of Internal Medicine, 2000
    Co-Authors: Jonathan M Edelman, James P Kemp, Jennifer A Turpin, Edwin A Bronsky, Jay Grossman, Asma F Ghannam, Paul Delucca, Glenn J Gormley, David S Pearlman
    Abstract:

    Background: Montelukast, an oral, once-daily leukotriene receptor antagonist, provides protection against exercise-induced bronchoconstriction. Objective: To evaluate the effect of 8 weeks of therapy with salmeterol aerosol or Montelukast on exercise-induced bronchoconstriction in adults with asthma. Design: 8-week multicenter, randomized, double-blind study. Setting: 17 asthma treatment centers in the United States. Patients: 191 adults with asthma who had documented exercise-induced bronchoconstriction. Intervention: Qualified patients were randomly assigned to double-blind treatment with Montelukast (10 mg once in the evening) or salmeterol (50 μg [2 puffs] twice daily). Measurements: Changes in pre-exercise and post-exercise challenge values; percentage inhibition in the maximal percentage decrease in FEV 1 ; the area above the FEV 1 -time curve; and time to recovery of FEV 1 at days 1 to 3, week 4, and week 8 of treatment. Results: By day 3, similar and statistically significant reductions in maximal percentage decrease in FEV 1 were seen with both therapies. Sustained improvement occurred in the Montelukast group at weeks 4 and 8; at these time points, the bronchoprotective effect of salmeterol decreased significantly. At week 8, the percentage inhibition in the maximal percentage decrease in FEV 1 was 57.2% in the Montelukast group and 33.0% in the salmeterol group (P = 0.002). By week 8, 67% of patients receiving Montelukast and 46% of patients receiving salmeterol had a maximal percentage decrease in FEV 1 of less than 20%. Conclusions: The bronchoprotective effect of Montelukast was maintained throughout 8 weeks of study. In contrast, significant loss of bronchoprotection at weeks 4 and 8 was seen with salmeterol. Long-term administration of Montelukast provided consistent inhibition of exercise-induced bronchoconstriction at the end of the 8-week dosing interval without tolerance.

  • oral Montelukast compared with inhaled salmeterol to prevent exercise induced bronchoconstriction a randomized double blind trial
    Annals of Internal Medicine, 2000
    Co-Authors: Jonathan M Edelman, James P Kemp, Jennifer A Turpin, Edwin A Bronsky, Jay Grossman, Asma F Ghannam, Paul Delucca, Glenn J Gormley, David S Pearlman
    Abstract:

    Background: Montelukast, an oral, once-daily leukotriene receptor antagonist, provides protection against exercise-induced bronchoconstriction. Objective: To evaluate the effect of 8 weeks of therapy with salmeterol aerosol or Montelukast on exercise-induced bronchoconstriction in adults with asthma. Design: 8-week multicenter, randomized, double-blind study. Setting: 17 asthma treatment centers in the United States. Patients: 191 adults with asthma who had documented exercise-induced bronchoconstriction. Intervention: Qualified patients were randomly assigned to double-blind treatment with Montelukast (10 mg once in the evening) or salmeterol (50 μg [2 puffs] twice daily). Measurements: Changes in pre-exercise and post-exercise challenge values; percentage inhibition in the maximal percentage decrease in FEV 1 ; the area above the FEV 1 -time curve; and time to recovery of FEV 1 at days 1 to 3, week 4, and week 8 of treatment. Results: By day 3, similar and statistically significant reductions in maximal percentage decrease in FEV 1 were seen with both therapies. Sustained improvement occurred in the Montelukast group at weeks 4 and 8; at these time points, the bronchoprotective effect of salmeterol decreased significantly. At week 8, the percentage inhibition in the maximal percentage decrease in FEV 1 was 57.2% in the Montelukast group and 33.0% in the salmeterol group (P = 0.002). By week 8, 67% of patients receiving Montelukast and 46% of patients receiving salmeterol had a maximal percentage decrease in FEV 1 of less than 20%. Conclusions: The bronchoprotective effect of Montelukast was maintained throughout 8 weeks of study. In contrast, significant loss of bronchoprotection at weeks 4 and 8 was seen with salmeterol. Long-term administration of Montelukast provided consistent inhibition of exercise-induced bronchoconstriction at the end of the 8-week dosing interval without tolerance.

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  • antisecretory antioxidative and antiapoptotic effects of Montelukast on pyloric ligation and water immersion stress induced peptic ulcer in rat
    Prostaglandins Leukotrienes and Essential Fatty Acids, 2010
    Co-Authors: Arunachalam Muthuraman, Shailja Sood
    Abstract:

    In the present study, we tried to explore the mechanism of Montelukast as an antiulcerogenic agent in pyloric ligation (PL) and water immersion stress (WIS) induced peptic ulcer. The ameliorative effects of Montelukast (5, 10, and 20 mg/kg, p.o.) on gastric volume and total acidity were studied in PL model. We have investigated the alteration in the ulcerative index, thiobarbituric acid reactive substances, reduced glutathione, activity of myeloperoxidase, and total calcium level in both models. Estimation of DNA fragmentation by gel electrophoresis was also performed. Medium and higher doses of Montelukast showed significant (p<0.05) ameliorative potential on all the above parameters as compared with omeprazole treated group. DNA fragmentation pattern clearly indicated the antiapoptotic effect of Montelukast in preventing mucosal erosion in both models. Hence, the gastroprotective effect of Montelukast may be attributed to its antisecretory, antioxidative along with its antiapoptotic effect.

  • antisecretory antioxidative and antiapoptotic effects of Montelukast on pyloric ligation and water immersion stress induced peptic ulcer in rat
    Prostaglandins Leukotrienes and Essential Fatty Acids, 2010
    Co-Authors: Arunachalam Muthuraman, Shailja Sood
    Abstract:

    Abstract In the present study, we tried to explore the mechanism of Montelukast as an antiulcerogenic agent in pyloric ligation (PL) and water immersion stress (WIS) induced peptic ulcer. The ameliorative effects of Montelukast (5, 10, and 20mg/kg, p.o.) on gastric volume and total acidity were studied in PL model. We have investigated the alteration in the ulcerative index, thiobarbituric acid reactive substances, reduced glutathione, activity of myeloperoxidase, and total calcium level in both models. Estimation of DNA fragmentation by gel electrophoresis was also performed. Medium and higher doses of Montelukast showed significant ( p