Clinical Assessment of Acupuncture for the Treatment of Chronic Asthma

Asthma Clinical Trial

Official title:

Clinical Assessment of Acupuncture for the Treatment of Asthma: A Randomized, Multicenter, Double-blind, Parallel-group Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931696
• Other study ID #: ZYSNXD-CC-ZDYJ039
• Status: Completed
• Phase: N/A
• First received: August 26, 2013
• Last updated: April 14, 2016
• Start date: July 2013
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of HealthChina: National Natural Science Foundation
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

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 ß2 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Verum acupuncture
100 patients receive verum acupuncture treatment once every other day,choosing Dazhui(GV14), Fengmen(BL12), Feishu(BL13), needles retention for 30 minutes and no moxibustion or electrical stimulation. Patients receive verum acupuncture once every other day with a total of 20 sessions in 6 weeks. The needle brand is Hwato®™ Sterile Acupuncture Needles for Single Use.
• Sham acupuncture
100 patients receive sham acupuncture treatment once every other day, choosing Jinsuo(DU08), Ganshu(BL18), Danshu(BL19), needles retention for 30 minutes and no moxibustion or electrical stimulation. Patients receive sham acupuncture once every other day with a total of 20 sessions in 6 weeks. The needle brand is Hwato®™ Sterile Acupuncture Needles for Single Use.

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Kaifeng Traditional Chinese Medicine hospital	Kaifeng	Henan
China	University Hospital of Gansu Traditional Chinese Medicine	Lanzhou	Gansu
China	Longhua Hospital	Shanghai	Shanghai
China	Shanghai Dachang hospital	Shanghai	Shanghai
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	Shanghai research institute of acupuncture and meridian,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine	Shanghai	Shanghai
China	Shanghai TCM Integrated hospital	Shanghai	Shanghai
China	Shuguang Hospital	Shanghai	Shanghai
China	Wenzhou Hospital of Traditional Chinese Medicine	Wenzhou	Zhejiang
China	No.3 hospital of Henan college of Traditional Chinese Medicine	Zhengzhou	Henan
China	Zhengzhou Traditional Chinese Medicine hospital	Zhengzhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	National Natural Science Foundation of China, Shanghai Municipal Health Bureau

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score Change from Baseline of Asthma Control Test		Measured during the 6 week treatment period	No
Secondary	Percentage of symptom-free days		Measured during the 6 week treatment period	No
Secondary	Usage of salbutamol and prednisone		Measured during the 6 week treatment period	No
Secondary	Lung function(FEV1, PVC, FEV1/FVC%, FEV1/predicted%),morning/evening PEF		Measured during the 6 week treatment period	No
Secondary	Asthma symptom scores		Measured during the 6 week treatment period	No
Secondary	Asthma quality of Life Questionnaire(AQLQ)		Measured during the 6 week treatment period	No
Secondary	Total number of exacerbations that require systemic corticosteroid therapy		Measured during the 6 week treatment period	No
Secondary	Eosinophil (EOS) count in peripheral blood, T cell classification, serum cytokine levels		Measured during the 6 week treatment period	No