NCT06869525

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

Study on the Efficacy and Mechanism of Acupuncture in the Acute Stage of Chronic Airway Diseases (Asthma and Chronic Obstructive Pulmonary Disease)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 576 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-03-11
• Last updated: 2025-03-11