Clinical Assessment of Acupuncture for the Treatment of Chronic Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Shanghai University of Traditional Chinese Medicine
Sponsor:
Collaborators:
Shanghai Municipal Health Bureau
National Natural Science Foundation of China
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01931696
First received: August 26, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

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


Condition Intervention
Asthma
Device: Verum acupuncture
Device: Sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Assessment of Acupuncture for the Treatment of Asthma: A Randomized, Multicenter, Double-blind, Parallel-group Controlled Trial

Resource links provided by NLM:


Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Total score Change from Baseline of Asthma Control Test [ Time Frame: Measured during the 6 week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of symptom-free days [ Time Frame: Measured during the 6 week treatment period ] [ Designated as safety issue: No ]
  • Usage of salbutamol and prednisone [ Time Frame: Measured during the 6 week treatment period ] [ Designated as safety issue: No ]
  • Lung function(FEV1, PVC, FEV1/FVC%, FEV1/predicted%),morning/evening PEF [ Time Frame: Measured during the 6 week treatment period ] [ Designated as safety issue: No ]
  • Asthma symptom scores [ Time Frame: Measured during the 6 week treatment period ] [ Designated as safety issue: No ]
  • Asthma quality of Life Questionnaire(AQLQ) [ Time Frame: Measured during the 6 week treatment period ] [ Designated as safety issue: No ]
  • Total number of exacerbations that require systemic corticosteroid therapy [ Time Frame: Measured during the 6 week treatment period ] [ Designated as safety issue: No ]
  • Eosinophil (EOS) count in peripheral blood, T cell classification, serum cytokine levels [ Time Frame: Measured during the 6 week treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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 Comparator: 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
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.

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

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931696

Contacts
Contact: Yong-Qing Yang, Ph.D 86-021-54592134 yyq@shutcm.edu.cn

Locations
China, Henan
No.3 hospital of Henan college of Traditional Chinese Medicine Recruiting
Zhengzhou, Henan, China, 450000
Contact: Su-Ju Shao, MD         
Principal Investigator: Su-Ju Shao, MD         
China, Hunan
Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Cheng-Ping Hu, Ph.D         
Principal Investigator: Cheng-Ping Hu, Ph.D         
China
Kaifeng Traditional Chinese Medicine hospital Recruiting
Kaifeng, China, 475000
Contact: Xiao-Yong Qin, MD         
Principal Investigator: Xiao-Yong Qin, MD         
Shanghai research institute of acupuncture and meridian,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Recruiting
Shanghai, China, 200030
Contact: Yu Wang, Ph.D         
Principal Investigator: Yu Wang, Ph.D         
Huashan hospital of Fudan university Not yet recruiting
Shanghai, China, 200030
Contact: Jing-Cheng Dong, Ph.D         
Principal Investigator: Jing-Cheng Dong, Ph.D         
Shanghai Dachang hospital Recruiting
Shanghai, China, 201900
Contact: Tie-Feng Zhang, Ph.D         
Principal Investigator: Tie-Feng Zhang, Ph.D         
Zhengzhou Traditional Chinese Medicine hospital Recruiting
Zhengzhou, China, 450000
Contact: Zhen li, MD         
Principal Investigator: Zhen Li, MD         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Shanghai Municipal Health Bureau
National Natural Science Foundation of China
Investigators
Study Chair: Yong-Qing Yang, Ph.D Shanghai University of TCM
  More Information

No publications provided

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01931696     History of Changes
Other Study ID Numbers: ZYSNXD-CC-ZDYJ039
Study First Received: August 26, 2013
Last Updated: August 26, 2013
Health Authority: China: Ethics Committee
China: Ministry of Health
China: National Natural Science Foundation

Keywords provided by Shanghai University of Traditional Chinese Medicine:
Efficacy
Acupuncture
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014