Clinical trial NCT01931696: Clinical Assessment of Acupuncture for the Treatment of Chronic Asthma
Official title: Clinical Assessment of Acupuncture for the Treatment of Asthma: A Randomized, Multicenter, Double-blind, Parallel-group Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Efficacy
Acupuncture
Asthma
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Health Bureau
name: National Natural Science Foundation of China
First posted: 2013-08-29
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether acupuncture is effective in the treatment of chronic asthma.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Total score Change from Baseline of Asthma Control Test
timeFrame: Measured during the 6 week treatment period
Secondary outcomes:
measure: Percentage of symptom-free days
timeFrame: Measured during the 6 week treatment period
measure: Usage of salbutamol and prednisone
timeFrame: Measured during the 6 week treatment period
measure: Lung function(FEV1, PVC, FEV1/FVC%, FEV1/predicted%)，morning/evening PEF
timeFrame: Measured during the 6 week treatment period
measure: Asthma symptom scores
timeFrame: Measured during the 6 week treatment period
measure: Asthma quality of Life Questionnaire(AQLQ)
timeFrame: Measured during the 6 week treatment period
measure: Total number of exacerbations that require systemic corticosteroid therapy
timeFrame: Measured during the 6 week treatment period
measure: Eosinophil (EOS) count in peripheral blood, T cell classification, serum cytokine levels
timeFrame: Measured during the 6 week treatment period
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: University Hospital of Gansu Traditional Chinese Medicine
state: Gansu
city: Kaifeng
country: China
facility: Kaifeng Traditional Chinese Medicine hospital
state: Henan
city: Zhengzhou
country: China
facility: No.3 hospital of Henan college of Traditional Chinese Medicine
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Traditional Chinese Medicine hospital
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai research institute of acupuncture and meridian，Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Dachang hospital
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai TCM Integrated hospital
state: Shanghai
city: Shanghai
country: China
facility: Shuguang Hospital
state: Shanghai
city: Wenzhou
country: China
facility: Wenzhou Hospital of Traditional Chinese Medicine
state: Zhejiang
Study officials:
affiliation: Shanghai University of TCM
name: Yong-Qing Yang, Ph.D
role: STUDY_CHAIR
References:
citation: Yin LM, Wang Y, Fan L, Xu YD, Wang WQ, Liu YY, Feng JT, Hu CP, Wang PY, Zhang TF, Shao SJ, Yang YQ. Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial. Trials. 2015 Sep 23;16:424. doi: 10.1186/s13063-015-0947-z.