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Clinical Trial NCT06869525 for COPD Exacerbation Acute, Asthma Acute is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Study on Acupuncture Treatment of Chronic Airway Diseases(Asthma and Chronic Obstructive Pulmonary Disease) 576
Clinical Trial NCT06869525 is an interventional study for COPD Exacerbation Acute, Asthma Acute and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2025 and continue until the study accrues 576 participants. Led by Henan University of Traditional Chinese Medicine, this study is expected to complete by 1 December 2027. The latest data from ClinicalTrials.gov was last updated on 11 March 2025.
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 sa...Show More
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, t...Show More
Official Title
Study on the Efficacy and Mechanism of Acupuncture in the Acute Stage of Chronic Airway Diseases (Asthma and Chronic Obstructive Pulmonary Disease)
Conditions
COPD Exacerbation AcuteAsthma AcuteOther Study IDs
- TCM for Chronic Airway Disease
NCT ID Number
Start Date (Actual)
2025-03
Last Update Posted
2025-03-11
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
576
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
COPD Exacerbation Acute
Asthma Acute
Acupuncture
Randomized Controlled Trial
Asthma Acute
Acupuncture
Randomized Controlled Trial
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAcupuncture group for Asthma Acute/AECOPD Patients in the Asthma Acute/AECOPD experimental group were treated with Acupuncture | 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. |
Sham ComparatorSham Acupuncture group for Asthma Acute/AECOPD Patients in the Asthma Acute/AECOPD experimental group were treated with Sham Acupuncture | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Astham part: the Asthma Control Test (ACT) | ACT includes five questions. Every question will be assessed using a 5-point scale with scores ranging from 5 to 25. The higher the score, the better the symptom control.25 is considered complete control level, 20 \~ 24 is considered good control level, and \<20 is considered non-control level. | Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up |
Asthma part：Asthma Control Questionnaire(ACQ) | The content of ACQ involves the following aspects: asthma-related, symptoms, the use of first-aid drugs, the impact on daily life and lung function test results.The higher the score, the worse the state. | 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) | The asthma quality of life scale (5-point scale-RRB- consists of 35 items, including activity limitation (1-12) , asthma symptoms (13-20) , psychological status (22-26) , response to stimuli (27-31) , concern for one's own health (32-35) . On a 5-point scale, 1 is the worst and 5 is the best. | 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) | Each indicator of the patient is scored from 1 to 5 based on the severity. After reverse scoring, the lower the score, the more severe the airway mucus hypersecretion and the poorer the therapeutic effect. | 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 | The assessment includes: the difficulty of expectoration score, the sputum character score, and the sputum viscosity grading. They represent the nature of the sputum and the difficulty of coughing, ranging from 0 to 3 points. The higher the score, the more mucus secretion in the airway and the more severe the symptoms. | Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up |
Asthma part：Evaluation of Airway Mucus by CT Imaging | Airway mucus CT assessment evaluates the distribution characteristics of airway mucus through the imaging features of thin-layer CT. | Before treatment, and day 7 |
Asthma part：Clinical symptom score | Including wheezing, coughing, expectoration, chest tightness and wheezing sounds.A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin. | Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up |
Asthma part：Acute attack status | Including the number and severity of acute attacks, the re-admission rate after acute attacks, and the interval between the first acute attack and the subsequent ones. | Follow-up at the 4th and 13th weeks |
Asthma part：Hospitalization time | The time required from the point of enrollment to the attainment of the discharge criteria | At 4 weeks of follow-up |
Asthma part：Fractional exhaled nitric oxide (FeNO) | FeNO is measured by a FeNO detector. It is used to determine the concentration of nitric oxide in exhaled breath of the human body. As a biomarker of airway inflammation, its normal range is less than 25ppb (adults) . | Before treatment, and day 7 |
COPD part：clinical symptoms and signs questionnaire | Assessment will be performed by clinical symptoms and signs questionnaire. The clinical symptoms to be evaluated in this study include cough, phlegm, chest tightness, gasp,shortness of breath, feeble and cyanosis. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin. | Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up |
COPD part：mMRC | The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "4" means severe dyspnea perception. | Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up |
COPD part：The cough and expectoration assessment questionnaire (CASA-Q) | Each indicator of the patient is scored from 1 to 5 based on the severity. After reverse scoring, the lower the score, the more severe the airway mucus hypersecretion and the poorer the therapeutic effect. | Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up |
COPD part：Evaluation of Airway Mucus Hypersecretion | The assessment includes: the difficulty of expectoration score, the sputum character score, and the sputum viscosity grading. They represent the nature of the sputum and the difficulty of coughing, ranging from 0 to 3 points. The higher the score, the more mucus secretion in the airway and the more severe the symptoms. | Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up |
COPD part：Evaluation of Airway Mucus by CT Imaging | Airway mucus CT assessment evaluates the distribution characteristics of airway mucus through the imaging features of thin-layer CT. | Before treatment, and day 7 |
COPD part：Acute attack status | The number of acute attacks | Follow-up at the 4th and 13th weeks |
COPD part：Hospitalization time | The time required from the point of enrollment to the attainment of the discharge criteria | At 4 weeks of follow-up |
COPD part：Tracheal intubation rate | The proportion of patients with tracheal intubation during the treatment period; | At 4 weeks of follow-up |
COPD part: Arterial blood gas | The arterial blood PaO2, PaCO2 of the two groups of subjects were measured. | Before treatment, and day 7 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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);
Henan University of Traditional Chinese Medicine- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Hebei Provincial Hospital of Traditional Chinese Medicine
Study Central Contact
Contact: Yang Xie, Professor, 13526621325, [email protected]
No location data.