Montelukast for Chronic Asthma in 6- to 14-Year-Old Children: A Randomized, Double-Blind Trial

Knorr, Barbara; Matz, Jonathan; Bernstein, Jonathan A.; Nguyen, Ha H.; Seidenberg, Beth; Reiss, Theodore F.

doi:10.1097/00132586-199902000-00032

Cited by 116 publications

(210 citation statements)

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“…The overall incidence of clinical and laboratory adverse events in these two groups was lower than that in the placebo group. Asthma exacerbations occurred more frequently in the placebo group (18,7 and 4% of patients affected in the placebo, montelukast and beclomethasone groups, respectively).…”

Section: Discussionmentioning

confidence: 97%

“…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].…”

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confidence: 99%

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

Baumgartner

Martínez²,

Edelman³

et al. 2003

Eur Respir J

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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

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Section: Discussionmentioning

confidence: 97%

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

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“…Montelukast is an orally bioavailable cysteinyl leukotriene (LT) receptor antagonist that is effective, safe, well tolerated, and approved by the U.S. Food and Drug Administration for preventive therapy for the inflammatory component in asthma and allergic rhinitis in children 2 years and older (21)(22)(23)(24), with no demonstrable development of tolerance in long-term studies (25,26). We have recently found that the cloned human cysteinyl LT receptors 1 and 2 (LT1-R, LT2-R) (27,28) have increased expression in the tonsillar tissues of children with SA (29).…”

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confidence: 99%

Leukotriene Modifier Therapy for Mild Sleep-disordered Breathing in Children

Goldbart

Goldman

Veling

et al. 2005

Am J Respir Crit Care Med

280

157

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Background: Children with mild sleep-disordered breathing (SDB), who may not be recommended for adenotonsillectomy, frequently exhibit neurocognitive and behavioral morbidity, and may benefit from alternative therapeutic interventions, such as leukotriene modifier therapy. Methods: Twenty-four children with SDB completed an open-label intervention study for 16 weeks with daily montelukast therapy. Sleep studies and adenoid size estimates from lateral X-ray films of the neck were obtained before and after treatment. In a parallel study, adenoid and tonsillar tissues from children with obstructive sleep apnea or recurrent throat infections were subjected to quantitative polymerase chain reaction, immunohistochemistry, and Western blotting for gene and protein expression of leukotriene receptors LT1-R and LT2-R, and for concentrations of LTB4 and LTC4/D4/E4. Results: Montelukast treatment induced significant reductions in adenoid size and respiratory-related sleep disturbances, which were absent in 16 children with SDB who did not receive treatment. LT1-R and LT2-R mRNA was similarly abundant in adenoid tissues, but increased LT1-R and LT2-R protein expression and higher levels of LTB4 and LTC4/D4/E4 emerged in children with obstructive sleep apnea. Conclusions: Oral therapy with a leukotriene modifier appears to be associated with improved breathing during sleep. Double-blind, placebo-controlled trials will be needed to corroborate current findings and solidly establish antiinflammatory strategies, such as leukotriene modifiers, as therapeutic alternatives in children with SDB too mild to justify referral for adenotonsillectomy.

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“…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.…”

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

et al. 2001

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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...

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Montelukast for Chronic Asthma in 6- to 14-Year-Old Children: A Randomized, Double-Blind Trial

Cited by 116 publications

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

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

Leukotriene Modifier Therapy for Mild Sleep-disordered Breathing in Children

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

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