Montelukast, a Once-Daily Leukotriene Receptor Antagonist, in the Treatment of Chronic Asthma&lt;subtitle&gt;A Multicenter, Randomized, Double-blind Trial&lt;/subtitle&gt;

Reiss, Theodore F.; Chervinsky, Paul; Dockhorn, Robert J.; Shingo, Sumiko; Seidenberg, Beth; Edwards, T. Bradley

doi:10.1001/archinte.158.11.1213

Cited by 467 publications

(309 citation statements)

References 27 publications

Supporting

Mentioning

283

Contrasting

Unclassified

Order By: Relevance

“…Leukotriene inhibitors, particularly leukotriene receptor antagonists, have been added in patients already taking inhaled GCS, with consistent improvements in lung function (80). An inhaled corticosteroid-sparing effect of one leukotriene receptor antagonist has been demonstrated in moderate to severe asthma (81), but these results are controversial (82).…”

Section: Leukotriene Inhibitorsmentioning

confidence: 99%

Difficult asthma

Garcia

and

Humbert

2003

Allergy

View full text Add to dashboard Cite

Section: Leukotriene Inhibitorsmentioning

confidence: 99%

Difficult asthma

Garcia

and

Humbert

2003

Allergy

View full text Add to dashboard Cite

“…Administered once daily in tablet form, montelukast reduces the signs and symptoms of chronic asthma in adults and children as young as 6 years of age, with a tolerability profile similar to that of placebo. [12][13] Additionally, montelukast had been shown to attenuate exercise-induced bronchoconstriction in these patients. 14 -15 Although single center studies have been performed, 16 to our knowledge, no large, multicenter studies have addressed the effects of leukotriene blockers in children with persistent asthma younger than 5 years of age.…”

mentioning

confidence: 99%

Montelukast, a Leukotriene Receptor Antagonist, for the Treatment of Persistent Asthma in Children Aged 2 to 5 Years

et al. 2001

Self Cite

View full text Add to dashboard Cite

ABSTRACT. Background. The greatest prevalence of asthma is in preschool children; however, the clinical utility of asthma therapy for this age group is limited by a narrow therapeutic index, long-term tolerability, and frequency and/or difficulty of administration. Inhaled corticosteroids and inhaled cromolyn are the most commonly prescribed controller therapies for young children with persistent asthma, although very young patients may have difficulty using inhalers, and dose delivery can be variable. Moreover, reduced compliance with inhaled therapy relative to orally administered therapy has been reported. One potential advantage of montelukast is the ease of administering a once-daily chewable tablet; additionally, no tachyphylaxis or change in the safety profile has been evidenced after up to 140 and 80 weeks of montelukast therapy in adults and pediatric patients aged 6 to 14 years, respectively.To our knowledge, this represents the first large, multicenter study to address the effects of a leukotriene receptor antagonist in children younger than 5 years of age with persistent asthma, as well as one of the few asthma studies that incorporated end points validated for use in preschool children.Objective. Our primary objective was to determine the safety profile of montelukast, an oral leukotriene receptor antagonist, in preschool children with persistent asthma. Secondarily, the effect of montelukast on exploratory measures of asthma control was also studied.Design and Statistical Analysis. We conducted a double-blind, multicenter, multinational study at 93 centers worldwide: including 56 in the United States, and 21 in countries in Africa, Australia, Europe, North America, and South America. In this study, we randomly assigned 689 patients (aged 2-5 years) to 12 weeks of treatment with placebo (228 patients) or 4 mg of montelukast as a chewable tablet (461 patients) after a 2-week placebo baseline period. Patients had a history of physician-diagnosed asthma requiring use of ␤-agonist and a predefined level of daytime asthma symptoms. Caregivers answered questions twice daily on a validated, asthmaspecific diary card and, at specified times during the study, completed a validated asthma-specific quality-oflife questionnaire. Physicians and caregivers completed a global evaluation of asthma control at the end of the study.Efficacy end points included: daytime and overnight asthma symptoms, daily use of ␤-agonist, days without asthma, frequency of asthma attacks, number of patients discontinued because of asthma, need for rescue medication, physician and caregiver global evaluations of change, asthma-specific caregiver quality of life, and peripheral blood eosinophil counts. Although exploratory, the efficacy end points were predefined and their analyses were written in a data analysis plan before study unblinding. At screening and at study completion, a complete physical examination was performed. Routine laboratory tests were drawn at screening and weeks 6 and 12, and submitted to a central laboratory for a...

show abstract

“…Antileukotriene agents, including montelukast, zafirlukast, pranlukast and the 5-lipoxygenase inhibitor zileuton, act by blocking the effects of the cysteinyl leukotrienes. Montelukast is an orally active, potent and specific cysteinyl leukotriene receptor antagonist that has been shown to improve the signs and symptoms of asthma in several placebo-controlled trials of patients with chronic asthma o2 yrs of age [6][7][8][9]. National and international consensus guidelines for treating asthma recommend daily controller therapy for patients with persistent asthma [10,11].…”

mentioning

confidence: 99%

Distribution of therapeutic response in asthma control between oral montelukast and inhaled beclomethasone

Baumgartner

Martínez²,

Edelman³

et al. 2003

Eur Respir J

View full text Add to dashboard Cite

The distribution of responses in study populations provides a novel method of comparing the benefit of two treatments. This 6-week, randomised, placebocontrolled, double-blind study compared the effectiveness of oral montelukast with inhaled beclomethasone in chronic asthma by assessing the distribution and overlap of patient responses to therapy, as measured by a clinical outcome (asthma control days).A total of 730 adult patients with asthma, age 15-65 yrs, with a forced expiratory volume in one second (FEV1) at baseline of 50-85% of predicted and o15% improvement in FEV1 after inhaled b-agonist were enrolled. After a 2-week placebo run-in period, patients were randomly allocated to receive montelukast (10 mg once daily), inhaled beclomethasone (200 mg twice daily) or placebo. The primary end-point (per cent of asthma control days) was compared between treatments as the overlap in the response distributions.The overlap of the distribution of responses between the montelukast and beclomethasone groups was 89% for per cent asthma control days and 96% for change from baseline in FEV1. The mean (¡SD) per cent asthma control days in the montelukast and beclomethasone groups was significantly higher than that in the placebo group (placebo 40.0 ¡ 35.8, montelukast 50.7 ¡ 37.1, beclomethasone 57.9 ¡ 36.1). The mean differences between montelukast and placebo, beclomethasone and placebo, and montelukast and beclomethasone were significant. The mean per cent change (¡SD) from baseline in FEV1 was 12.1¡18.7 and 13.9¡20.8 in the montelukast and beclomethasone groups, respectively, and significantly greater than that in the placebo group (6.4¡20.1); there was no significant difference between the montelukast and beclomethasone groups in mean values or response distribution. There was also no difference among treatment groups in the frequency of adverse experiences.A comparison of the response distribution is an important approach to comparing therapies; montelukast and beclomethasone provided similar response distributions for the end-point of per cent asthma control days over a 6-week treatment period. Eur Respir J 2003; 21: 123-128

show abstract

Montelukast, a Once-Daily Leukotriene Receptor Antagonist, in the Treatment of Chronic Asthma<subtitle>A Multicenter, Randomized, Double-blind Trial</subtitle>

Cited by 467 publications

References 27 publications

Difficult asthma

Difficult asthma

Montelukast, a Leukotriene Receptor Antagonist, for the Treatment of Persistent Asthma in Children Aged 2 to 5 Years

Distribution of therapeutic response in asthma control between oral montelukast and inhaled beclomethasone

Contact Info

Product

Resources

About