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

NCT06869525 | Not Yet Recruiting DMC

• 1 other identifier: TCM for Chronic Airway Disease
• Study Type: interventional
• Target: 576
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD Exacerbation Acute; Asthma Acute

Keywords

COPD Exacerbation Acute; Asthma Acute; Acupuncture; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Astham part: PEF

  Record the peak expiratory flow rate(PEF) for each patient, and evaluate the impact of acupuncture on improving the peak expiratory flow (PEF) of asthma patients.

  Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up

• COPD part：CTA

  Record the COPD Assessment Test (CAT) for each patient, and evaluate the impact of acupuncture on improving the clinical symptoms of patients with AECOPD.

  Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up

Secondary Outcomes (19)

• Astham part: the Asthma Control Test (ACT)

  Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up

• Asthma part：Asthma Control Questionnaire(ACQ)

  Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up

• Asthma part：Asthma Quality of Life Questionnaire(AQLQ)

  Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up

• Asthma part：The cough and expectoration assessment questionnaire (CASA-Q)

  Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up

• Asthma part：Evaluation of Airway Mucus Hypersecretion

  Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up

Study Arms (2)

Acupuncture group for Asthma Acute/AECOPD

EXPERIMENTAL

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

Behavioral: Acupuncture

Sham Acupuncture group for Asthma Acute/AECOPD

SHAM COMPARATOR

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

Behavioral: Sham Acupuncture

Interventions

Acupuncture 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.

Acupuncture group for Asthma Acute/AECOPD

Sham Acupuncture 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.

Sham Acupuncture group for Asthma Acute/AECOPD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: collaborator
• Hebei Provincial Hospital of Traditional Chinese Medicine: collaborator

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Suyun Li, Professor

  First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Yang Xie, Professor

CONTACT

13526621325; xieyanghn@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 11, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-01