The Effects of Montelukast on Sputum Cells and Inflammatory Markers in Smokers With Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Sputum Neutrophil Percentages
研究概览
简要总结
The purpose of this study is:
- To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices between smokers and non-smokers.
- To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.
详细描述
Many smokers have insufficient control of their symptoms due to inefficacy of ICS in this subpopulation of asthmatics. Cigarette smoking has been shown to stimulate production of cysLTs. CysLTs could activate production of IL-8 for neutrophilia as well as cause eosinophilia in the airway of asthmatics.
LTRAs are felt to be less efficacious than ICS in smokers with asthma. However, LTRA's unique mechanism of action could be particularly efficacious in preventing worsening symptoms and lung function for smokers with asthma. Given this, along with the fact that ICS are less effective in smokers, targeting cysLT could lead to significant clinical benefits for asthmatic smokers.
Data from this study may possibly serve as crucial data for the significant clinical benefits for asthmatic smokers and determination of the mechanism of corticosteroid resistance in smokers 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
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asthmatics:
- •clinical history of asthma for at least 1 year
- •with evidence of reversible airway obstruction,
- •two documented FEV1 between 60-85%,
- •PC20 < 4mg/ml by methacholine challenge test
- •and average baseline β-agonist use of 2 puffs/day
- •smoke 1/2 to 2 packs a day
- •with a smoking history of 5-30 pack years
- •Non-smokers:
- •Non-smokers will have either never smoked or have stopped smoking cigarettes over 5 years ago
排除标准
- •positive HCG (for females)
- •have a respiratory tract infection or need oral corticosteroids within the preceding 6 weeks
- •history of COPD or respiratory disorder other than asthma
- •history of psychiatric illness
- •allergy to fluticasone propionate, salmeterol, montelukast or any of their components
- •significant, unstable medical condition other than asthma
- •history of life-threatening asthma exacerbation requiring intubation and mechanical ventilation in the last ten years
研究组 & 干预措施
1
Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months
干预措施: Fluticasone Propionate (Drug)
1
Asthmatic smokers treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months
干预措施: Salmeterol (Drug)
2
Asthmatic smoker treated with Montelukast only:
Montelukast dosage: PO 10 mg QHS for 3 months
干预措施: Montelukast (Drug)
3
Non-smoking asthmatics treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months
干预措施: Fluticasone Propionate (Drug)
3
Non-smoking asthmatics treated with combination therapy:
Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months
干预措施: Salmeterol (Drug)
4
Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage: PO 10 mg QHS for 3 months
干预措施: Montelukast (Drug)
结局指标
主要结局
Sputum Neutrophil Percentages
时间窗: 24 weeks
Week 24 sputum neutrophil percentages were measured in active treatment groups.
次要结局
- Sputum Eosinophil Percentages(24 weeks)
- Sputum IL-8 Levels(24 weeks)
- Sputum GM-CSF Levels(24 weeks)
- Sputum IFN-gamma/IL-5 Ratios(24 weeks)
- Sputum Eotaxin Levels(24 weeks)
- Sputum RANTES Levels(24 weeks)
研究者
Chang-Keun Kim, Dr.
Director, Asthma and Allergy Center; Chairman of Pediatrics; Professor of Pediatrics
Inje University