Clinical trial NCT06869525: Study on Acupuncture Treatment of Chronic Airway Diseases(Asthma and Chronic Obstructive Pulmonary Disease)
Official title: Study on the Efficacy and Mechanism of Acupuncture in the Acute Stage of Chronic Airway Diseases (Asthma and Chronic Obstructive Pulmonary Disease)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD Exacerbation Acute
Asthma Acute
Keywords: COPD Exacerbation Acute
Asthma Acute
Acupuncture
Randomized Controlled Trial
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: Hebei Provincial Hospital of Traditional Chinese Medicine
First posted: 2025-03-11
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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);

Primary outcomes:
measure: Astham part: PEF
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
measure: COPD part：CTA
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Secondary outcomes:
measure: Astham part: the Asthma Control Test (ACT)
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
measure: Asthma part：Asthma Control Questionnaire(ACQ)
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
measure: Asthma part：Asthma Quality of Life Questionnaire(AQLQ)
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
measure: Asthma part：The cough and expectoration assessment questionnaire (CASA-Q)
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
measure: Asthma part：Evaluation of Airway Mucus Hypersecretion
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
measure: Asthma part：Evaluation of Airway Mucus by CT Imaging
timeFrame: Before treatment, and day 7
measure: Asthma part：Clinical symptom score
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
measure: Asthma part：Acute attack status
timeFrame: Follow-up at the 4th and 13th weeks
measure: Asthma part：Hospitalization time
timeFrame: At 4 weeks of follow-up
measure: Asthma part：Fractional exhaled nitric oxide (FeNO)
timeFrame: Before treatment, and day 7
measure: COPD part：clinical symptoms and signs questionnaire
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
measure: COPD part：mMRC
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
measure: COPD part：The cough and expectoration assessment questionnaire (CASA-Q)
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
measure: COPD part：Evaluation of Airway Mucus Hypersecretion
timeFrame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
measure: COPD part：Evaluation of Airway Mucus by CT Imaging
timeFrame: Before treatment, and day 7
measure: COPD part：Acute attack status
timeFrame: Follow-up at the 4th and 13th weeks
measure: COPD part：Hospitalization time
timeFrame: At 4 weeks of follow-up
measure: COPD part：Tracheal intubation rate
timeFrame: At 4 weeks of follow-up
measure: COPD part: Arterial blood gas
timeFrame: Before treatment, and day 7
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Suyun Li, Professor
role: STUDY_CHAIR
References: