Clinical Assessment of Acupuncture for the Treatment of Chronic Asthma

Shanghai University of Traditional Chinese Medicine

Status: Completed

Conditions: Asthma

Treatments: Device: Sham acupuncture; Device: Verum acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01931696

ZYSNXD-CC-ZDYJ039

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Verum acupuncture

Experimental group

Description:

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

Treatment:

Device: Verum acupuncture

Sham acupuncture

Sham Comparator group

Description:

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

Treatment:

Device: Sham acupuncture