Clinical Assessment of Acupuncture for the Treatment of Asthma: A Randomized, Multicenter, Double-blind, Parallel-group Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Total score Change from Baseline of Asthma Control Test
研究概览
简要总结
The purpose of this study is to assess whether acupuncture is effective in the treatment of chronic asthma.
详细描述
Asthma is a common chronic disease worldwide with an estimated 300 million affected individuals. In analyses of economic burden of asthma, apart from direct medical costs including hospital admissions and cost of medications, indirect, non-medical costs such as time lost from work account for a considerable part. For all but the most severe patients, the ultimate goal is to prevent symptoms, minimize morbidity from acute episodes, and prevent functional and psychological morbidity to provide a near healthy lifestyle. Although the symptoms can be controlled by drug treatment in most patients, effective low-risk, non-drug approaches such as acupuncture could constitute a significant advance in asthma management. The purpose of this study is to assess whether acupuncture is effective in the treatment of chronic asthma.
There is a 1-week screening period(-1 week) during which participants will be monitored while they use an albuterol inhaler as needed. Study visits will occur at weeks 0(Baseline), weeks 3, weeks 6. Participants will undergo a physical examination, lung function, blood and urine collection. At the Weeks 0 study visit, participants will be randomly assigned to one of the following two groups for 6 weeks of treatment:
- Group 1 will receive verum acupuncture treatment once every two days plus albuterol as needed, prednisone for exacerbation
- Group 2 will receive sham acupuncture treatment once every two days plus albuterol as needed, prednisone for exacerbation
Study visits will occur at Weeks 0, 3, 6. A physical examination, blood collection, and lung function will occur at selected visits. Questionnaires to assess asthma control and quality of life will also be completed. Throughout the study, participants will record asthma symptoms and medication usage in a daily diary.
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
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with mild-to-moderate persistent asthma
- •Forced expiratory volume in one second (FEV1) reversibility of greater than or equal to 12% following bronchodilator administration (2 puffs)
- •Patients who have given written informed consent
排除标准
- •Participation in another clinical trial 1 month prior to study entry
- •Use of systemic corticosteroids 2 weeks prior to study entry
- •Patients with general infection, lower respiratory infection, pulmonary tuberculosis and fungal infection 1 month prior to study entry
- •Hospitalization due to acute exacerbation 3 months prior to study entry
- •Patients cannot stop using forbidden drugs which include inhaled corticosteroid, theophylline, long-term β2 agonist, sodium cromoglicate, leukotrienes antagonist and anticholinergic drug
- •Patients who are allergic to albuterol and corticosteroid
- •Patients with severe primary diseases such as cancer, cardiovascular system, liver, kidney and hematopoietic system diseases
- •Wheeze caused by pulmonary tuberculosis, bronchiectasia and cardiac insufficiency
- •Patients with hyperthyroidism
- •Patients with mental illness, acrasia
- •Female patients in pregnancy, lactation period and planning to get pregnant during the trial
- •Any significant disorder that in the investigator's opinion, might put the patients at risk or influence the study outcomes
- •Acupuncture contraindications: serious allergic or infectious dermatitis and hemorrhagic diseases such as thrombocytopenic purpura and hemophilia
结局指标
主要结局
Total score Change from Baseline of Asthma Control Test
时间窗: Measured during the 6 week treatment period
次要结局
- Usage of salbutamol and prednisone(Measured during the 6 week treatment period)
- Total number of exacerbations that require systemic corticosteroid therapy(Measured during the 6 week treatment period)
- Lung function(FEV1, PVC, FEV1/FVC%, FEV1/predicted%)，morning/evening PEF(Measured during the 6 week treatment period)
- Percentage of symptom-free days(Measured during the 6 week treatment period)
- Asthma symptom scores(Measured during the 6 week treatment period)
- Asthma quality of Life Questionnaire(AQLQ)(Measured during the 6 week treatment period)
- Eosinophil (EOS) count in peripheral blood, T cell classification, serum cytokine levels(Measured during the 6 week treatment period)
研究者
Yong-Qing Yang
Professor
Shanghai University of Traditional Chinese Medicine