Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 33
- 主要终点
- Asthma control questionnaire (ACQ)
研究概览
简要总结
Asthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of breath, chest tightness and cough, usually occurring at night or early morning. However, there are still some patients with only persistent clinical manifestations of chest tightness. Concerned about this group of patients, investigators presented a subgroup of bronchial asthma, namely, chest tightness variant asthma (CTVA). This asthma subgroup usually lacks asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and therefore often misdiagnosed for a long time. However, there is lack of definite treatment strategy for CTVA. In order to further understand the clinical characteristics and treatment of patients with CTVA, investigators conducted a national multicenter randomized control trial(RCT) study that compares inhaled corticosteroid(ICS)/ long-acting beta2-agonist(LABA) + Montelukast with ICS/LABA. Finally, investigators plan to clarify whether ICS/LABA plus Montelukast is more appropriate treatment than only ICS/LABA in CTVA patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent;
- •the age of more than 14 and less 80 years old, gender and ethnicity are not limited;
- •the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough;
- •no wheezing;
- •a diagnosis of asthma supported by one or more other characteristics:
- •bronchial provocation test positive;
- •improvement in forced expiratory volume at one second (FEV1) of more than 12% and 200 mL after inhaled salbutamol;
- •variability in diurnal peak expiratory flow (PEF) of more than 10% for one day during one week.
- •bronchodilator and glucocorticoid treatment is effective;
- •exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease(GERD), neuromuscular disease, and mental disease.
排除标准
- •can not cooperate with related inspection or for other reasons;
- •patients with chronic obstructive pulmonary disease, interstitial pneumonia, active tuberculosis, community acquired pneumonia, lung cancer, bronchiectasis, cor pulmonale, pulmonary embolism, and accompanied with serious systematic disease (such as coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease, neuromuscular disease, etc);
- •history of drug abuse, alcohol abuse or anesthesia or with a history of mental illness (schizophrenia, obsessive-compulsive disorder, depression) and against personality, motivation, suspicious, or other emotional or mental issues that may affect participation in the study;
- •taking part in other drug clinical trial project, or drop out less than 3 months;
- •during pregnancy, lactation women;
- •obvious abnormal of High Resolution CT.
研究组 & 干预措施
ICS/LABA plus Montelukast
干预措施: Inhaled corticosteriod/long-acting beta-agonist plus Montelukast (Drug)
ICS/LABA only
干预措施: Inhaled corticosteriod/long-acting beta-agonist only (Drug)
结局指标
主要结局
Asthma control questionnaire (ACQ)
时间窗: Change from baseline intervention therapy at 3 months
Scores of asthma control questionnaire (ACQ)
次要结局
- Peak expiratory flow(Change from baseline intervention therapy at 3 months)
- Forced expiratory volume in one second(Change from baseline intervention therapy at 3 months)
- Airway responsiveness(Change from baseline intervention therapy at 3 months)
- Asthma quality of life questionnaire(Change from baseline intervention therapy at 3 months)
- Acute asthma episode(Change from baseline intervention therapy at 3 months)
- Numbers of emergency or hospitalization(Change from baseline intervention therapy at 3 months)