Study on Acupuncture Treatment of Chronic Airway Diseases(Asthma and Chronic Obstructive Pulmonary Disease)

NCT ID: NCT06869525

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-12-31

Brief Summary

For patients in the acute phase of chronic airway diseases, on the basis of guideline-directed treatment, the experimental group was given acupuncture treatment, while the control group was given sham acupuncture treatment. The treatment lasted for one week, followed by a 13-week follow-up. For asthma and COPD, PEF and CAT were respectively used as the primary outcome measures to evaluate the clinical efficacy and safety of acupuncture. Based on the improvement of the primary outcome measures, the advantageous population was identified. The mechanism by which acupuncture reduces airway mucus hypersecretion was preliminarily explained.

Detailed Description

This study was a multicenter, randomized, double-blind, controlled trial. A total of 336 patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and 240 patients with acute attack of asthma were included. On the basis of guideline-directed treatment, the experimental group received acupuncture treatment, while the control group was given sham acupuncture treatment. For patients with AECOPD, the acupoints selected were Zhongfu, Dingchuan, Tiantu, Fenglong, and Feishu. For patients with acute attack of asthma, the acupoints selected were Dingchuan, Zhongfu, Tiantu, Feishu, and Kongzui. The acupoints were connected to electroacupuncture and treated for 30 minutes. The control group received sham acupuncture treatment. The acupoints were located 5 to 10 mm away from the actual acupoints, and the needles were inserted superficially through the skin. The acupoints were connected to electroacupuncture but without electricity. The treatment lasted for 30 minutes, once a day, for one week. Follow-up was conducted for 13 weeks. For COPD, the COPD Assessment Test (CAT) was the primary outcome measure, and the secondary outcome measures included the mMRC scale, assessment of airway mucus hypersecretion, CT assessment of airway mucus, basic vital signs, clinical symptom scores, use of control medications and antibiotics, acute exacerbation status, hospitalization time, tracheal intubation rate, and arterial blood gas. For asthma, the peak expiratory flow (PEF) was the primary outcome measure, and the secondary outcome measures included the Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality of Life Questionnaire (AQLQ), assessment of airway mucus hypersecretion, CT assessment of airway mucus, basic vital signs, clinical symptom scores, use of control medications and antibiotics, acute attack status, hospitalization time, and fractional exhaled nitric oxide (FeNO). The clinical efficacy and safety of acupuncture were evaluated. The population with advantages was identified based on the improvement of the primary outcome measures. The mechanism of acupuncture in reducing airway mucus hypersecretion was preliminarily explained.

Conditions

COPD Exacerbation Acute; Asthma Acute

Study Design

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

Study Groups

Acupuncture group for Asthma Acute/AECOPD

Patients in the Asthma Acute/AECOPD experimental group were treated with Acupuncture

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: BEHAVIORAL

Dingchuan, Shanzhong, Tiantu, Feishu, Kongji, after obtaining qi, connect the electric needle (continuous wave, The frequency was 2Hz, the current intensity was 1\~5mA, and the current intensity was gradually increased according to patient tolerance), and the treatment was 30min.

Sham Acupuncture group for Asthma Acute/AECOPD

Patients in the Asthma Acute/AECOPD experimental group were treated with Sham Acupuncture

Group Type: SHAM_COMPARATOR

Sham Acupuncture

Intervention Type: BEHAVIORAL

Dingchuan, Shanzhong, Tiantu, Feishu, hole the most points open 5\~10mm, shallow piercing through the skin, connected with the electric needle but no electricity, treatment 30min.

Interventions

Acupuncture

Dingchuan, Shanzhong, Tiantu, Feishu, Kongji, after obtaining qi, connect the electric needle (continuous wave, The frequency was 2Hz, the current intensity was 1\~5mA, and the current intensity was gradually increased according to patient tolerance), and the treatment was 30min.

Intervention Type: BEHAVIORAL

Sham Acupuncture

Dingchuan, Shanzhong, Tiantu, Feishu, hole the most points open 5\~10mm, shallow piercing through the skin, connected with the electric needle but no electricity, treatment 30min.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Meets the diagnostic criteria for acute attack of asthma/AECOPD;
• Age range from18 years to 80 years(asthma) and 40 yesrs to 80 years(COPD);
• The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.

Exclusion Criteria

• Patients with combined pulmonary abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis and other pulmonary diseases;
• Patients with severe cardiovascular and cerebrovascular diseases (such as malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, grade 3 or above cardiac function, stroke, cerebral hemorrhage, etc.);
• Patients with severe liver diseases (such as liver cirrhosis, portal hypertension and bleeding caused by esophageal and gastric fundus varices) and severe kidney diseases (such as dialysis, kidney transplantation, etc.);
• Patients with impaired consciousness or various mental disorders who are unable to communicate normally;
• Pregnant and lactating women;
• Those who are currently participating in other clinical trials within 1 month before enrollment;
• Patients with contraindications to acupuncture (such as severe allergic or infectious skin diseases);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Hebei Provincial Hospital of Traditional Chinese Medicine

OTHER_GOV

Sponsor Role: collaborator

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suyun Li, Professor

Role: STUDY_CHAIR

First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Central Contacts

Yang Xie, Professor

Role: CONTACT

xieyanghn@163.com

13526621325

Other Identifiers

TCM for Chronic Airway Disease

Identifier Type: -

Identifier Source: org_study_id