CHU Ste-Justine, Université de Montréal, Montréal, Québec, Canada.
Merck Canada Inc., Kirkland, Québec, Canada ; Current address: Novartis Canada, Dorval, Québec, Canada.
Allergy Asthma Clin Immunol. 2014 May 6;10(1):21. doi: 10.1186/1710-1492-10-21. eCollection 2014.
Asthma 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.
Twelve-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.
A 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.
Montelukast 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.
This study is registered at ClinicalTrial.gov: NCT00832455.
哮喘是儿童最常见的慢性疾病，也是儿童发病的主要原因。本研究旨在根据加拿大哮喘共识指南评估孟鲁司特作为单一疗法或与当前吸入皮质类固醇（ICS）联合治疗未得到控制的哮喘儿科患者的有效性。
为期 12 周的多中心、开放性、观察性研究。主要有效性结果是在第 4 周和第 12 周达到哮喘控制（哮喘控制问卷（ACQ）评分≤0.75）的患者比例。
共纳入 328 名未得到控制的哮喘（ACQ>0.75）患者，平均年龄为 6.9±3.4 岁。其中，76 名（23.2%）患者接受孟鲁司特单药治疗，252 名（76.8%）患者接受孟鲁司特联合 ICS 治疗。治疗 4 周后，单药组和联合组分别有 61.3%和 52.9%的患者达到哮喘控制。这些比例在 12 周时分别增加至 75.0%和 70.9%。在单药组中，ACQ 评分（基线时的平均±标准差为 1.67±0.69、4 周和 12 周时分别为 0.71±0.70 和 0.50±0.52；p<0.001）和 PACQLQ 评分（基线时的平均±标准差为 5.34±1.14、4 周和 12 周时分别为 6.32±0.89 和 6.51±0.85；p<0.001）均有显著改善。在联合组中，ACQ 评分（基线时的平均±标准差为 2.02±0.83，4 周时为 0.90±0.86，12 周时为 0.64±0.86；p<0.001）从基线显著改善，而 PACQLQ 评分（基线时的平均±标准差为 4.42±1.35，4 周时为 5.76±1.30，12 周时为 6.21±1.03；p<0.001）从基线时显著改善。在接受孟鲁司特加用治疗 12 周后，22.6%的患者减少了 ICS 剂量。在学龄前和学龄期患者中也观察到类似的结果。
孟鲁司特作为单一疗法或与 ICS 联合治疗是一种有效的治疗策略，可用于实现儿科患者的哮喘控制并提高照顾者的生活质量。
本研究在 ClinicalTrials.gov 上注册：NCT00832455。
