A Randomized Open-Label Comparative Study of Montelukast versus Theophylline Added to Inhaled Corticosteroid in Asthmatic Children

Kondo, Naomi; Katsunuma, Toshio; Odajima, Yasuhei; Morikawa, Akihiro

doi:10.2332/allergolint.55.287

Cited by 18 publications

(15 citation statements)

References 24 publications

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“…The observed safety and tolerability results are consistent with the safety profile of montelukast previously reported in asthma childhood [2,13,14,22,24-26,37-39]. …”

Section: Discussionsupporting

confidence: 90%

Effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid in pediatric patients with uncontrolled asthma: a prospective cohort study

Bérubé

Djandji

Sampalis

et al. 2014

All Asth Clin Immun

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BackgroundAsthma is the most common chronic disease of childhood and a leading cause of childhood morbidity. The aim of the current study was to assess the effectiveness of montelukast administered as monotherapy or in combination with current inhaled corticosteroids (ICS) in pediatric patients with uncontrolled asthma as per the Canadian Asthma Consensus Guidelines.MethodsTwelve-week, multicentre, open-label, observational study. Primary effectiveness outcome was the proportion of patients achieving asthma control (Asthma Control Questionnaire (ACQ) score ≤0.75) at weeks 4 and 12.ResultsA total of 328 patients with uncontrolled asthma (ACQ > 0.75) were enrolled with mean ± SD age of 6.9 ± 3.4 years. Among these, 76 (23.2%) were treated with montelukast monotherapy and 252 (76.8%) with montelukast combined with ICS. By 4 weeks of treatment 61.3% and 52.9% of the patients in the monotherapy and combination group, respectively, achieved asthma control. These proportions increased to 75.0% and 70.9%, respectively, at 12 weeks. Within the monotherapy group, clinically significant improvements in the ACQ score (mean ± SD of 1.67 ± 0.69, 0.71 ± 0.70 and 0.50 ± 0.52 at baseline, 4 and 12 weeks, respectively; p < 0.001) and the PACQLQ score (mean ± SD of 5.34 ± 1.14, 6.32 ± 0.89 and 6.51 ± 0.85 at baseline, 4 and 12 weeks, respectively; p < 0.001) were observed. In the combination group, the mean ± SD ACQ score significantly improved from 2.02 ± 0.83 at baseline to 0.90 ± 0.86 at 4 weeks and 0.64 ± 0.86 at 12 weeks (p < 0.001), while the PACQLQ score improved from 4.42 ± 1.35 at baseline to 5.76 ± 1.30 at 4 weeks and 6.21 ± 1.03 at 12 weeks (p < 0.001). After a 12-week montelukast add-on therapy, 22.6% of patients reduced their ICS dosage. Similar results were observed among preschool- and school-aged patients.ConclusionsMontelukast as monotherapy or in combination with ICS represents an effective treatment strategy for achieving asthma control in pediatric patients and improving caregivers’ quality of life.Trial registrationThis study is registered at ClinicalTrial.gov: NCT00832455.

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“…The observed safety and tolerability results are consistent with the safety profile of montelukast previously reported in asthma childhood [2,13,14,22,24-26,37-39]. …”

Section: Discussionsupporting

confidence: 90%

Effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid in pediatric patients with uncontrolled asthma: a prospective cohort study

Bérubé

Djandji

Sampalis

et al. 2014

All Asth Clin Immun

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“…46 Less serious side effects of montelukast occur uncommonly, but may include pharyngitis, dizziness, nausea, headache, diarrhea, fever, abdominal pain and rash. 33,36,[41][42][43][44] The incidence of adverse events associated with montelukast is comparable to those of other standard therapies for asthma in childhood and in some studies montelukast was equivalent to placebo. 40 Although FDA approval for montelukast has been obtained for children $2 years of age, safety data to date suggest that this agent may also be used for younger patients between the ages of 6 months and 2 years.…”

Section: Safetymentioning

confidence: 68%

“…33,[36][37][38][39][40][41][42][43][44][45] Serious adverse events, such as worsening asthma, appear to be rare 46 and all reported patients with drug overdoses recovered without sequelae. 46 Less serious side effects of montelukast occur uncommonly, but may include pharyngitis, dizziness, nausea, headache, diarrhea, fever, abdominal pain and rash.…”

Section: Safetymentioning

confidence: 99%

Montelukast Sodium: Administration to Children to Control Intermittent Asthma

2010

Clinical Medicine Reviews in Therapeutics

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The prototype cysteinyl leukotriene receptor antagonist, montelukast, is generally considered to have a niche application in the chemotherapy of exercise-induced asthma. It has also been used as add-on therapy in patients whose asthma is poorly controlled with inhaled corticosteroid monotherapy, or with the combination of a long-acting β(2)-agonist and an inhaled corticosteroid. Recently, however, montelukast has been reported to possess secondary anti-inflammatory properties, apparently unrelated to conventional antagonism of cysteinyl leukotriene receptors. These novel activities enable montelukast to target eosinophils, monocytes, and, in particular, the corticosteroid-insensitive neutrophil, suggesting that this agent may have a broader spectrum of anti-inflammatory activities than originally thought. If so, montelukast is potentially useful in the chemotherapy of intermittent asthma because most exacerbations of this condition involve respiratory virus infection-triggered inflammatory mechanisms which, to a large extent, involve airway epithelial cell/neutrophil interactions. The primary objective of this review is to evaluate the role of montelukast in the treatment of intermittent asthma in children.

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“…70, 71 One small trial showed that the addition of theophylline to inhaled corticosteroids resulted in improvement in peak expiratory flow, but did not improve FEV1 or bronchial reactivity. 72 Given the lack of substantial supporting evidence, potential toxicity, and need for frequent monitoring, theophylline is not part of first-line therapy for children with asthma and is not recommended for children under 5.…”

Section: Alternatives To Inhaled Corticosteroidsmentioning

confidence: 99%

Pediatric Asthma

Huffaker

Phipatanakul

2015

Immunology and Allergy Clinics of North America

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Synopsis Over the past several decades, the evidence supporting rational pediatric asthma management has grown exponentially. As more is learned about the various phenotypes of asthma, the complexity of management will continue to grow. This review focuses on the evidence supporting the current guidelines-based pediatric asthma management and explores the future of asthma management with respect to phenotypic heterogeneity and biologics.

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A Randomized Open-Label Comparative Study of Montelukast versus Theophylline Added to Inhaled Corticosteroid in Asthmatic Children

Abstract: The results indicate that montelukast added to low-dose ICS is an effective and safe option for the treatment of asthma in children.

Cited by 18 publications

References 24 publications

Effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid in pediatric patients with uncontrolled asthma: a prospective cohort study

Effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid in pediatric patients with uncontrolled asthma: a prospective cohort study

Montelukast Sodium: Administration to Children to Control Intermittent Asthma

Pediatric Asthma

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