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Clinical Assessment of Acupuncture for the Treatment of Chronic Asthma

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ClinicalTrials.gov Identifier: NCT01931696
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : April 15, 2016
Sponsor:
Collaborators:
Shanghai Municipal Health Bureau
National Natural Science Foundation of China
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE August 26, 2013
First Posted Date  ICMJE August 29, 2013
Last Update Posted Date April 15, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
Total score Change from Baseline of Asthma Control Test [ Time Frame: Measured during the 6 week treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
  • Percentage of symptom-free days [ Time Frame: Measured during the 6 week treatment period ]
  • Usage of salbutamol and prednisone [ Time Frame: Measured during the 6 week treatment period ]
  • Lung function(FEV1, PVC, FEV1/FVC%, FEV1/predicted%),morning/evening PEF [ Time Frame: Measured during the 6 week treatment period ]
  • Asthma symptom scores [ Time Frame: Measured during the 6 week treatment period ]
  • Asthma quality of Life Questionnaire(AQLQ) [ Time Frame: Measured during the 6 week treatment period ]
  • Total number of exacerbations that require systemic corticosteroid therapy [ Time Frame: Measured during the 6 week treatment period ]
  • Eosinophil (EOS) count in peripheral blood, T cell classification, serum cytokine levels [ Time Frame: Measured during the 6 week treatment period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Assessment of Acupuncture for the Treatment of Chronic Asthma
Official Title  ICMJE Clinical Assessment of Acupuncture for the Treatment of Asthma: A Randomized, Multicenter, Double-blind, Parallel-group Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Device: Verum acupuncture
  • 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
    Intervention: Device: Sham acupuncture
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2013)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01931696
Other Study ID Numbers  ICMJE ZYSNXD-CC-ZDYJ039
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Shanghai University of Traditional Chinese Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Shanghai University of Traditional Chinese Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Shanghai Municipal Health Bureau
  • National Natural Science Foundation of China
Investigators  ICMJE
Study Chair: Yong-Qing Yang, Ph.D Shanghai University of TCM
PRS Account Shanghai University of Traditional Chinese Medicine
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP