Montelukast Added to Inhaled Beclomethasone in Treatment of Asthma

Laviolette, Michel; Malmström, Kerstin; Lu, Susan; Chervinsky, Paul; Pujet, Jean-Claude; Peszek, Izabella; Zhang, Ji; Reiss, Theodore F.

doi:10.1164/ajrccm.160.6.9803042

Cited by 323 publications

(219 citation statements)

References 29 publications

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“…12,13 In fact, in a recent study of adults with chronic asthma, montelukast provided additional asthma control to patients benefiting from, but incompletely controlled on, inhaled beclomethasone. 19 Of note, there are few randomized controlled studies of asthma therapies for preschool children. This may be partly because clinical end points are difficult to measure in this patient population and symptom burden and ␤-agonist use in children is less than that seen in adults.…”

Section: Discussionmentioning

confidence: 99%

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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Section: Discussionmentioning

confidence: 99%

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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“…18 They reduce the number of eosinophils in induced sputum 19 and in peripheral blood of asthmatic patients. 20 They reduce eosinophil migration to lungs. 14 They are capable of interfering with improvement of airway remodeling.…”

Section: What Do Treatment Guidelines Recommend?mentioning

confidence: 99%

Antileucotrienos no tratamento da asma e rinite alérgica

Ribeiro¹,

Toro²,

Baracat³

2006

J. Pediatr. (Rio J.)

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Objective: To compare leukotriene antagonists (LTA) to other groups of drugs used in asthma and allergic rhinitis treatment.Sources: MEDLINE, LILACS and Cochrane Library. Keywords: leukotrienes, antileukotrienes, asthma treatment, allergic rhinitis treatment, asthma and allergic rhinitis. An attempt was made to group the main studies and reviews about this topic Summary of the findings: LTA are more efficient than placebo and enhance the effects of inhaled corticosteroids. The association of inhaled corticosteroids with long-acting ß2 agonists is more efficient than the association of inhaled corticosteroids + LTA. Although use of LTA in acute asthma attacks and allergic rhinitis seems reasonable, more studies are needed to confirm this benefit. LTA reduce hospitalization time and the number of wheezing attacks in infants with acute viral bronchiolitis caused by respiratory syncytial virus, as well as recurrent wheezing after acute viral bronchiolitis. LTA are less efficient than intranasal corticosteroids for allergic rhinitis management. LTA are efficient in exercise-induced asthma, although they are not the first-line treatment. Conclusion:Controlled and randomized studies show that inhaled corticosteroids are the drugs of choice to treat persistent asthma and allergic rhinitis. There is not enough evidence to recommend the use of LTA as first-line drug (monotherapy) in children with asthma (level I). For children who cannot use inhaled corticosteroids, LTA may be a good alternative (level II).J Pediatr (Rio J). 2006;82(5 Suppl):S213-21: Asthma, exercise-induced asthma, rhinitis, antileukotrienes, montelukast, zafirlukast.

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“…1 Another RCT in adults also showed a treatment benefit after 16 weeks of beclomethasone plus montelukast. 2 For safety, caution is always needed when using tablets in young children. The American Academy of Pediatrics notes that safe swallowing can be difficult for young children for reasons of anatomy, experience, and judgment.…”

Section: Commentarymentioning

confidence: 99%

Montelukast moderately decreased asthma symptoms in children with persistent asthma

Mazur

2002

ACP Journal Club

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Montelukast Added to Inhaled Beclomethasone in Treatment of Asthma

Cited by 323 publications

References 29 publications

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

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

Antileucotrienos no tratamento da asma e rinite alérgica

Montelukast moderately decreased asthma symptoms in children with persistent asthma

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