Randomised, Open-label, Parallel-group Study of Therapeutic Effect of Leukotriene Modulator Montelukast Alone or Combined With Inhaled Corticosteroid on Cough Variant Asthma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Day-time and night-time cough symptom total-score changes from baseline to visit 4
研究概览
简要总结
This study aims to observe the therapeutic effect of leukotriene modulator montelukast alone or combined with inhaled corticosteroid(ICS) on cough variant asthma(CVA).
The investigators hypothesize:
- Cough score and cough reflex sensitivity will be improved after treatment with montelukast, inhaled corticosteroid/β2 agonist(ICS/LABA), and two combinations.
- Combination of leukotriene modulator and inhaled corticosteroid/β2 agonist may have better efficacy when compared to montelukast, corticosteroid/β2 agonist alone while MON, is comparable to symbicort.
详细描述
Study groups:
99 patients diagnosed with CVA will be randomised into three groups as follows:
Group 1: inhaled corticosteroid+β2 agonist The patients with cough variant asthma received Symbicort Turbuhaler (Budesonide 160µg and Formoterol 4.5µg) 1puff Q12h for 8 weeks.
Group 2: montelukast The patients with cough variant asthma received montelukast 10mg QN for 8 weeks, without any other corticosteroid or β2 agonist.
Group 3: montelukast combined with inhaled corticosteroid+β2 agonist The patients with cough variant asthma received montelukast 10mg QN combined with Symbicort Turbuhaler (Budesonide 160µg and Formoterol 4.5µg) 1puff Q12h for 8 weeks..
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
- •Patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
- •There is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least).
- •Patients whose chest x-ray outcome was normal or without any active focus.
- •Patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).
排除标准
- •Patients demonstrate FEV1/FVC <70% in lung function test. FEV1 stands for forced expiratory volume in 1 second, FVC stands for forced vital capacity.
- •Patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history >10 pack-years or equivalence.
- •Patients with concomitance of GERC (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, ACEI induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
- •Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
- •Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
- •Subjects who have received any therapy in the previous seven days, e.g. oral/ inhaled/systematic corticosteroid, long-acting β2 agonist, theophylline sustained release.
- •Subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia.
- •Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.
研究组 & 干预措施
Montelukast
Monotherapy with Montelukast 10mg, take orally ,every night,for 8 weeks
干预措施: Montelukast (Drug)
ICS/LABA and Montelukast
Combination therapy with inhaled corticosteroid/β2 agonist 160/4.5ug,twice a day and Montelukast 10mg，take orally,every night for 8 weeks
干预措施: ICS/LABA and Montelukast (Drug)
ICS/LABA
Monotherapy with corticosteroid/β2 agonist 160/4.5ug,inhaled, twice a day, for 8 weeks
干预措施: ICS/LABA (Drug)
结局指标
主要结局
Day-time and night-time cough symptom total-score changes from baseline to visit 4
时间窗: 8 weeks
次要结局
- Cough reflex sensitivity changes in different groups at baseline, visit 2, visit3, and visit 4. Cell differential changes in hypertonic saline induced sputum in different groups at baseline, visit 2, visit3, and visit 4.(8 weeks)
研究者
Kefang Lai
professor
The First Affiliated Hospital of Guangzhou Medical University