Clinical Assessment of Acupuncture for the Treatment of Chronic Asthma

NCT ID: NCT01931696

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Verum acupuncture

Verum acupuncture treatment once every two days + Albuterol sulfate HFA (Ventolin®™ 100 mcg Inhalation Aerosol) as needed + Prednisone Acetate Tablets(H31020675, 5 mg oral tablet) for exacerbation

Group Type: EXPERIMENTAL

Verum acupuncture

Intervention Type: DEVICE

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

Sham acupuncture treatment once every two days + Albuterol sulfate HFA (Ventolin®™ 100 mcg Inhalation Aerosol) as needed + Prednisone Acetate Tablets(H31020675, 5 mg oral tablet) for exacerbation

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Municipal Health Bureau

OTHER_GOV

Sponsor Role: collaborator

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yong-Qing Yang, Ph.D

Role: STUDY_CHAIR

Shanghai University of TCM

Locations

University Hospital of Gansu Traditional Chinese Medicine

Lanzhou, Gansu, China

Kaifeng Traditional Chinese Medicine hospital

Kaifeng, Henan, China

No.3 hospital of Henan college of Traditional Chinese Medicine

Zhengzhou, Henan, China

Zhengzhou Traditional Chinese Medicine hospital

Zhengzhou, Henan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Shanghai research institute of acupuncture and meridian，Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, Shanghai Municipality, China

Shanghai Dachang hospital

Shanghai, Shanghai Municipality, China

Longhua Hospital

Shanghai, Shanghai Municipality, China

Shanghai TCM Integrated hospital

Shanghai, Shanghai Municipality, China

Shuguang Hospital

Shanghai, Shanghai Municipality, China

Wenzhou Hospital of Traditional Chinese Medicine

Wenzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 26399399 (View on PubMed)

Other Identifiers

ZYSNXD-CC-ZDYJ039

Identifier Type: -

Identifier Source: org_study_id