A Randomized Controlled Study of Montelukast Plus Low Dose Inhaled Budesonide Versus Medium Dose Inhaled Budesonide on Asthma Control in Elderly Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Rate of patients reaching "well controlled asthma status"
研究概览
简要总结
To compare the efficacy of combination therapy of montelukast plus low dose inhaled budesonide and single therapy of medium dose inhaled budesonide on asthma control such as inflammatory markers and clinical indicators and to compare treatment response according to leukotriene related genotypes in elderly patients with asthma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 60 - 75 years
- •Patients diagnosed with asthma (NIH, 2007) over six months ago
- •Patients maintaining monotherapy of low dose inhaled budesonide (pulmicort 400µg/day or ciclesonide 160 µg/day or fluticasone 250 µg/day) or combination of low dose inhaled budesonide and LABA (Seretide® 250 µg/day or Symbicort® 320 µg/day ) for over a month before the participation in this trial
- •Patients not reaching 'well controlled asthma status' with four-week monotherapy of low dose inhaled budesonide (Pulmicort 400 µg/day)
- •Patients who sufficiently listen to the purpose and content of this trial and the properties of investigational products and voluntarily agree with the participation to sign a written consent approved by IRB of Ajou University Medical Center before the participation in this trial
排除标准
- •Patients who show a symptom of an acute disease within 28 days before the beginning of this trial (administration of trial medication)
- •Volunteers who are found to be unsuitable through screening tests
- •Patients with history of hypersensitivity to montelukast or budesonide
- •Patients participating in other clinical trial within three months before the beginning of this trial (administration of trial medication)
- •current smokers having more than 10PYs of smoking history
- •Patients needing administration of a medication which can affect asthma control such as systemic and immunoregulatory drugs (cyclosporin, omalizumab, etc.) due to a disease except asthma
研究组 & 干预措施
Monotherapy of medium dose ICS
干预措施: Monotherapy of medium dose ICS (Drug)
Combination of low ICS and montelukast
干预措施: Combination of low ICS and montelukast (Drug)
结局指标
主要结局
Rate of patients reaching "well controlled asthma status"
时间窗: 12-weeks treatment
Rate of patients reaching "well controlled asthma status" after 12-week treatment : evaluating comprehensively frequency of day symptoms and night symptoms, limit of activities and use of rescue medicine based on GINA guideline for asthma management (GINA 2006) and PEF or FEV1(% predicted)
次要结局
- Time to first well-controlled week(during the 12 weeks of treatment)
- Sub-group analysis of leukotrienes associated genotypes(visit 1)
- Biomarkers of inflammation(baseline(W1), W5, W9, W13, W17)
研究者
Hae-Sim Park
Professor, Department of allergy part, Ajou University School of Medicine
Ajou University School of Medicine