COPD Exacerbation AcuteNCT06869525
Study on Acupuncture Treatment of Chronic Airway Diseases(Asthma and Chronic Obstructive Pulmonary Disease)
A study testing Acupuncture in people with COPD Exacerbation Acute and Asthma Acute, run by Henan University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD Exacerbation Acute, Asthma Acute
- What is being tested?
- Acupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 576 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Efficacy and Mechanism of Acupuncture in the Acute Stage of Chronic Airway Diseases (Asthma and Chronic Obstructive Pulmonary Disease)
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.
Read the 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
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- COPD Exacerbation Acute, Asthma Acute, Acupuncture, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureBehavioural
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 AcupunctureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group for Asthma Acute/AECOPD | Experimental | Patients in the Asthma Acute/AECOPD experimental group were treated with Acupuncture Receives: Behavioral: Acupuncture |
| Sham Acupuncture group for Asthma Acute/AECOPD | Sham comparator | Patients in the Asthma Acute/AECOPD experimental group were treated with Sham Acupuncture Receives: Behavioral: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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) .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before treatment, and day 7
COPD part：Acute attack status
The number of acute attacks
Measured: 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
Measured: At 4 weeks of follow-up
COPD part：Tracheal intubation rate
The proportion of patients with tracheal intubation during the treatment period;
Measured: At 4 weeks of follow-up
COPD part: Arterial blood gas
The arterial blood PaO2, PaCO2 of the two groups of subjects were measured.
Measured: Before treatment, and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD Exacerbation AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Hebei Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Suyun Li, Professor, Study chair, First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869525
- Sponsor's protocol ID
- TCM for Chronic Airway Disease
- Status last verified
- Jan 2025
- First submitted
- 18 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu S, Yang Q, Zhang P, Xu J, Li S, Xie Y. Efficacy of electroacupuncture in the treatment of Acute Exacerbation of Chronic Obstructive Pulmonary disease: study protocol for a multicenter, randomized, sham-controlled trial. Front Med (Lausanne). 2026 Jul 13;13:1879332. doi: 10.3389/fmed.2026.1879332. eCollection 2026.
PubMed 42517050
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Mechanism of Acupuncture in the Acute Stage of Chronic Airway Diseases (Asthma and Chronic Obstructive Pulmonary Disease)
- ClinicalTrials.gov ID
- NCT06869525
- Acronym / sponsor ID
- TCM for Chronic Airway Disease
- Conditions
- COPD Exacerbation Acute, Asthma Acute
- Keywords
- COPD Exacerbation Acute, Asthma Acute, Acupuncture, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Hebei Provincial Hospital of Traditional Chinese Medicine
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group for Asthma Acute/AECOPD | Experimental | Behavioral: AcupuncturePatients in the Asthma Acute/AECOPD experimental group were treated with Acupuncture |
| Sham Acupuncture group for Asthma Acute/AECOPD | Sham comparator | Behavioral: Sham AcupuncturePatients in the Asthma Acute/AECOPD experimental group were treated with Sham Acupuncture |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureDingchuan, 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. | Behavioural | Acupuncture group for Asthma Acute/AECOPD |
| Sham AcupunctureDingchuan, 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. | Behavioural | Sham Acupuncture group for Asthma Acute/AECOPD |
Primary outcome
Astham part: PEF
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
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.
COPD part：CTA
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Record the COPD Assessment Test (CAT) for each patient, and evaluate the impact of acupuncture on improving the clinical symptoms of patients with AECOPD.
19 secondary outcomes
Astham part: the Asthma Control Test (ACT)
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Asthma part：Asthma Control Questionnaire(ACQ)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Before treatment, and day 7
Asthma part：Clinical symptom score
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
Asthma part：Acute attack status
Time frame: Follow-up at the 4th and 13th weeks
Asthma part：Hospitalization time
Time frame: At 4 weeks of follow-up
Asthma part：Fractional exhaled nitric oxide (FeNO)
Time frame: Before treatment, and day 7
COPD part：clinical symptoms and signs questionnaire
Time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
COPD part：mMRC
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Before treatment, and day 7
COPD part：Acute attack status
Time frame: Follow-up at the 4th and 13th weeks
COPD part：Hospitalization time
Time frame: At 4 weeks of follow-up
COPD part：Tracheal intubation rate
Time frame: At 4 weeks of follow-up
COPD part: Arterial blood gas
Time frame: Before treatment, and day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 42517050Zhu S, Yang Q, Zhang P, Xu J, Li S, Xie Y. Efficacy of electroacupuncture in the treatment of Acute Exacerbation of Chronic Obstructive Pulmonary disease: study protocol for a multicenter, randomized, sham-controlled trial. Front Med (Lausanne). 2026 Jul 13;13:1879332. doi: 10.3389/fmed.2026.1879332. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suyun Li, Professor study chair
First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with COPD Exacerbation Acute and Asthma Acute, run by Henan University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Xie, Professor (13526621325, xieyanghn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Astham part: PEF (time frame: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.