Study on the Efficacy and Mechanism of Acupuncture in the Acute Stage of Chronic Airway Diseases (Asthma and Chronic Obstructive Pulmonary Disease)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 576
- 主要终点
- COPD part：CTA
研究概览
简要总结
For patients in the acute phase of chronic airway diseases, on the basis of guideline-directed treatment, the experimental group was given acupuncture treatment, while the control group was given sham acupuncture treatment. The treatment lasted for one week, followed by a 13-week follow-up. For asthma and COPD, PEF and CAT were respectively used as the primary outcome measures to evaluate the clinical efficacy and safety of acupuncture. Based on the improvement of the primary outcome measures, the advantageous population was identified. The mechanism by which acupuncture reduces airway mucus hypersecretion was preliminarily explained.
详细描述
This study was a multicenter, randomized, double-blind, controlled trial. A total of 336 patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and 240 patients with acute attack of asthma were included. On the basis of guideline-directed treatment, the experimental group received acupuncture treatment, while the control group was given sham acupuncture treatment. For patients with AECOPD, the acupoints selected were Zhongfu, Dingchuan, Tiantu, Fenglong, and Feishu. For patients with acute attack of asthma, the acupoints selected were Dingchuan, Zhongfu, Tiantu, Feishu, and Kongzui. The acupoints were connected to electroacupuncture and treated for 30 minutes. The control group received sham acupuncture treatment. The acupoints were located 5 to 10 mm away from the actual acupoints, and the needles were inserted superficially through the skin. The acupoints were connected to electroacupuncture but without electricity. The treatment lasted for 30 minutes, once a day, for one week. Follow-up was conducted for 13 weeks. For COPD, the COPD Assessment Test (CAT) was the primary outcome measure, and the secondary outcome measures included the mMRC scale, assessment of airway mucus hypersecretion, CT assessment of airway mucus, basic vital signs, clinical symptom scores, use of control medications and antibiotics, acute exacerbation status, hospitalization time, tracheal intubation rate, and arterial blood gas. For asthma, the peak expiratory flow (PEF) was the primary outcome measure, and the secondary outcome measures included the Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality of Life Questionnaire (AQLQ), assessment of airway mucus hypersecretion, CT assessment of airway mucus, basic vital signs, clinical symptom scores, use of control medications and antibiotics, acute attack status, hospitalization time, and fractional exhaled nitric oxide (FeNO). The clinical efficacy and safety of acupuncture were evaluated. The population with advantages was identified based on the improvement of the primary outcome measures. The mechanism of acupuncture in reducing airway mucus hypersecretion was preliminarily explained.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for acute attack of asthma/AECOPD;
- •Age range from18 years to 80 years(asthma) and 40 yesrs to 80 years(COPD);
- •The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.
排除标准
- •Patients with combined pulmonary abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis and other pulmonary diseases;
- •Patients with severe cardiovascular and cerebrovascular diseases (such as malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, grade 3 or above cardiac function, stroke, cerebral hemorrhage, etc.);
- •Patients with severe liver diseases (such as liver cirrhosis, portal hypertension and bleeding caused by esophageal and gastric fundus varices) and severe kidney diseases (such as dialysis, kidney transplantation, etc.);
- •Patients with impaired consciousness or various mental disorders who are unable to communicate normally;
- •Pregnant and lactating women;
- •Those who are currently participating in other clinical trials within 1 month before enrollment;
- •Patients with contraindications to acupuncture (such as severe allergic or infectious skin diseases);
结局指标
主要结局
COPD part：CTA
时间窗: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Record the COPD Assessment Test (CAT) for each patient, and evaluate the impact of acupuncture on improving the clinical symptoms of patients with AECOPD.
Astham part: PEF
时间窗: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Record the peak expiratory flow rate(PEF) for each patient, and evaluate the impact of acupuncture on improving the peak expiratory flow (PEF) of asthma patients.
次要结局
- Asthma part：Asthma Quality of Life Questionnaire(AQLQ)(Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up)
- Asthma part：The cough and expectoration assessment questionnaire (CASA-Q)(Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up)
- Asthma part：Asthma Control Questionnaire(ACQ)(Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up)
- Astham part: the Asthma Control Test (ACT)(Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up)
- Asthma part：Evaluation of Airway Mucus by CT Imaging(Before treatment, and day 7)
- Asthma part：Evaluation of Airway Mucus Hypersecretion(Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up)
- Asthma part：Clinical symptom score(Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up)
- Asthma part：Acute attack status(Follow-up at the 4th and 13th weeks)
- Asthma part：Hospitalization time(At 4 weeks of follow-up)
- Asthma part：Fractional exhaled nitric oxide (FeNO)(Before treatment, and day 7)
- COPD part：clinical symptoms and signs questionnaire(Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up)
- COPD part：mMRC(Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up)
- COPD part：The cough and expectoration assessment questionnaire (CASA-Q)(Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up)
- COPD part：Evaluation of Airway Mucus Hypersecretion(Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up)
- COPD part：Evaluation of Airway Mucus by CT Imaging(Before treatment, and day 7)
- COPD part：Acute attack status(Follow-up at the 4th and 13th weeks)
- COPD part：Hospitalization time(At 4 weeks of follow-up)
- COPD part：Tracheal intubation rate(At 4 weeks of follow-up)
- COPD part: Arterial blood gas(Before treatment, and day 7)