Clinical Study on the Efficacy of Compound Sodium Chlorate and Aminophylline Tablets for Mild to Moderate Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD).
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- COPD assessment test(CAT) score
研究概览
简要总结
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an important event in the management of chronic obstructive pulmonary disease. Compound sodium chlolate and aminophylline tablets are one of the most widely used drugs for the treatment of bronchial asthma and chronic bronchitis.
详细描述
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an unignorable event in the management of chronic obstructive pulmonary disease. It is crucial to seek for effective management strategy. Compound sodium chlolate and aminophylline tablets are one of the most widely used drugs for the treatment of bronchial asthma and chronic bronchitis. Compared with the local bronchodilator recommended by the guidelines, it has the advantages of convenient use and good patient compliance. For the purpose of optimize the management of acute exacerbation of chronic obstructive pulmonary disease and provide more convenient options, we compared the efficacy of combined compound sodium chlolate and aminophylline tablets with nebulized ipratropium bromide inhalation plus systemic glucocorticoids in the treatment of chronic obstructive pulmonary disease ranging from moderate degree to severe degree. We hope this research would benefit patients with chronic obstructive pulmonary, especially those in the grassroots.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)All subjects must sign an informed consent form before participating in the clinical trial.
- •(2)Clinical diagnosis of AECOPD. (3)Must be able to swallow tablets.
排除标准
- •(1)Heart disease. (2)Insulin dependent diabetes. (3)Tumor disease. (4)Thyroid disease. (5)Infectious diseases such as hepatitis B, active tuberculosis, etc. (6)Active peptic ulcer. (7)Allergic to related treatments. (8)Participate in other clinical trials within three months. (9)Women who are breast-feeding, pregnant or preparing for pregnancy.
研究组 & 干预措施
AECOPD(P+C1)
Placebo Tablets(P) three times a day, one tablet at a time; combined with Compound Ipratropium Bromide Solution(C1) 2.5ml atomized inhalation twice a day.
干预措施: Compound Ipratropium Bromide Solution(C1) for Inhalation (Drug)
AECOPD(P+C1)
Placebo Tablets(P) three times a day, one tablet at a time; combined with Compound Ipratropium Bromide Solution(C1) 2.5ml atomized inhalation twice a day.
干预措施: Placebo Tablets (Drug)
AECOPD(C1+C2)
Compound Sodium Chlolate and Aminophylline Tablets(C2) three times a day, one tablet at a time; combined with Compound Ipratropium Bromide Solution(C1) 2.5ml atomized inhalation twice a day.
干预措施: Compound Ipratropium Bromide Solution(C1) for Inhalation (Drug)
AECOPD(C1+C2)
Compound Sodium Chlolate and Aminophylline Tablets(C2) three times a day, one tablet at a time; combined with Compound Ipratropium Bromide Solution(C1) 2.5ml atomized inhalation twice a day.
干预措施: Compound Sodium Chlolate and Aminophylline Tablets(C2) (Drug)
结局指标
主要结局
COPD assessment test(CAT) score
时间窗: The above test was given to the experimental group and the control group on the first, fourth, and eighth days after the treatment.
Observe the changes in the symptoms of dyspnea each time.The CAT score consists of eight items, each of which has options of 0, 1, 2, 3, 4, and 5. The lower the total score plus the score for the eight items, the lighter the symptoms of COPD.The first item, whether there is cough; the second item, sputum condition; the third item, whether there is chest tightness; the fourth item, when climbing a hill or climbing a layer of stairs, is there any breathlessness;the fifth item, whether chronic obstructive pulmonary disease affects housework; the sixth item, whether it affects going out; the seventh item, sleep situation; the eighth item, whether the energy is sufficient.
Potential of Hydrogen(PH),Partial pressure of oxygen(PO2),Partial pressure of carbon dioxide(PCO2)
时间窗: The above test was given to the experimental group and the control group on the first, fourth, and eighth days after the treatment.
Arterial blood gas values were monitored, the values measured at each examination were recorded, and changes between each time were observed.
次要结局
- Forced Expiratory Volume in the first second (FEV1)/Forced Vital Capacity(FVC)(The above test was given to the test group and the control group on the first and eighth days after the treatment.)
研究者
Yang Jin
Department of Respiratory and Critical Care Medicine, NHC Key Laboratory of Pulmonary Diseases
Wuhan Union Hospital, China