Chronic Obstructive Pulmoriary Disease (COPD)NCT06691802
Clinical Study on the Treatment of Chronic Airway Diseases (Asthma, Chronic Obstructive Pulmonary Disease) with Shu Fei Tie
A study testing Shu Fei Tie in people with Chronic Obstructive Pulmoriary Disease (COPD) and Asthma, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Conduct a multi-center, large-sample, randomized controlled clinical study of "winter disease being cared in summer" with Shu Fei Tie prevent recurrence of Asthma and COPD, scientifically evaluate the clinical efficacy and safety of Shu Fei Tie in reducing the recurrence of chronic airway diseases, identify target… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmoriary Disease (COPD), Asthma
- What is being tested?
- Shu Fei Tie
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,312 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to Jul 2028
- 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 asthma/COPD(Group E in the GOLD classification); ② 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 other pulmonary diseases (lung abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis，etc);
- Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, heart grade 3 or above, stroke, cerebral hemorrhage, etc.);
- Patients with severe liver diseases (liver cirrhosis, portal hypertension, and caused by esophageal and gastric varices) and severe kidney diseases (dialysis, kidney transplantation, etc.);
- Patients with impaired consciousness or various illnesses who cannot communicate normally; ⑤Pregnant and lactating women; ⑥Patients who are participating in other clinical trials within one month prior to enrollment; ⑦Patients who have received acupuncture or other traditional Chinese medicine external treatments within the past year; ⑧ Patients who are allergic to external patches
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan
Suyun Li PhD, 13938415502, lisuyun2000@126.com
About this study
Official title: Clinical Study on Reducing Recurrent Attacks of Chronic Airway Diseases (asthma, Chronic Obstructive Pulmonary Disease) with Shu Fei Tie Based on "winter Disease Being Cared in Summer"
Conduct a multi-center, large-sample, randomized controlled clinical study of "winter disease being cared in summer" with Shu Fei Tie prevent recurrence of Asthma and COPD, scientifically evaluate the clinical efficacy and safety of Shu Fei Tie in reducing the recurrence of chronic airway diseases, identify target population, clarify the mechanism of efficacy, and establish a prevention and treatment technology plan for Shu Fei Tie to reduce the recurrence of chronic airway diseases.
Read the detailed description
Asthma and Chronic obstructive pulmonary disease (COPD) are the most common chronic airway diseases, and their recurrent episodes or acute exacerbations are the main reasons for the decline in patients' quality of life and heavy economic burden. Based on the of "winter disease being cared in summer", traditional Chinese medicine (TCM) has a long history and wide application in preventing and treating the recurrence of chronic air diseases, with obvious advantages of combining TCM and Western medicine. However, there is a lack of integrated TCM and Western medicine technical schemes for chronic airway based on high-level evidence-based evidence. The Shu Fei Tie developed by our project team is a medical institution preparation that has been used clinically for a long. Therefore, this study conducted a multi-center, large-sample, randomized controlled clinical study of the Shu Fei Tie to prevent the recurrence of asthma and COPD. The study subjects were patients in the remission period of asthma (1332 cases) and the stable period of COPD (980 cases) On the basis of treatment guided by the guidelines, the experimental group was given the Shu Fei Tie, and the control group was given a placebo of theu Fei Tie. The treatment started 10 days before the " the first Fu" and was conducted every 10 days, A total of 5 times, Each treatment lasted 6-8 hours, and the follow-up period was 45 weeks, for a total of 3 cycles (3 years). The outcome indicators were the number of acute attacks per year for asthma and the number of acute exacerbations per year for COPD. The secondary outcome indicators for asthma included Asthma Control Test (ACT) score, the Asthma Control Questionnaire (ACQ), and the Asthma Quality of Life Questionnaire (AQLQ). For COPD, the secondary outcome indicators included clinical symptom scores and lung function. This study scientifically evaluated the clinical efficacy and safety of the Shu Fei Tie reducing the recurrence of chronic airway diseases, identified the advantageous population, elucidated the mechanism of efficacy, and established a technical scheme for preventing and treating the recurrence of chronic airway diseases with the Shu Fei Tie.
- Being tested
- Shu Fei Tie, Shu Fei Tie placebo
- Keywords
- Chronic Obstructive Pulmoriary Disease, Asthma, Shu Fei Tie, Winter disease being cared in summer, Randomized Controlled Trial
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shu Fei TieDrug
Optimize the extraction process and matrix formulation, and combine the use of traditional Chinese medicine volatile oil and chemical transdermal enhancers to develop adermal patch（Shu Fei Tie）
Shu Fei Tie placeboDrug
Shu Fei Tie Placebos are made using substances without active drug ingredients, following the same preparation procedures
| Study group | Role | What they receive |
|---|---|---|
| Shu Fei Tie group for Asthma/COPD | Experimental | Patients in the Asthma/COPD experimental group were treated with Shu Fei Tie Receives: Drug: Shu Fei Tie |
| Shu Fei Tie Placebo group for Asthma/COPD | Placebo comparator | Patients in the Asthma/COPD experimental group were treated with Shu Fei Tie Placebo Receives: Drug: Shu Fei Tie placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma part：Number of acute attacks per year
Record the number of acute attacks per year for each patient, and evaluate the effect of the lung-clearing patch on reducing the number of acute attacks
Measured: Count once a year for three consecutive years
COPD part：The number of acute exacerbations per year
Record the number of acute exacerbations in patients per year to evaluate the treatment effect of Shu Fei Tie on patients.
Measured: Count once a year for three consecutive years
COPD part：the interval between successive acute exacerbations
Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
Measured: at weeks 13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)，Until the first acute exacerbation occurs
COPD part:the number of rehospitalizations within a year
Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
Measured: Count once a year until the end of the 3-year cycle
Secondary outcomes (20)
Asthma part：Asthma Control Test
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: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Asthma Control Questionnaire
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: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Asthma Quality of Life Questionnaire
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: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Frequency of anti-inflammatory and analgesic use
Detailed record of the use of treatment drugs, evaluation of treatment effect
Measured: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Disease Control Rate
Based on the disease control situation, the disease control rate is calculated and the efficacy is evaluated.
Measured: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：readmission rate
The impact on patient prognosis was evaluated by calculating the number of readmissions.
Measured: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Forced expiratory volume in the first second
FEV1 will be applied to assess pulmonary function
Measured: Before treatment, at weeks 52, 104, and 156 of treatment
Asthma part：Peak expiratory flow
PEF will be applied to assess pulmonary function
Measured: Before treatment, at weeks 52, 104, and 156 of treatment
Asthma part：Fractional exhaled nitric oxide
PEF will be used to evaluate the patient's airway inflammation
Measured: Before treatment, at weeks 52, 104, and 156 of treatment
Asthma 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, expectoration, chest tightness, gasp and wheezing. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin.
Measured: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
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: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
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: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：CAT
0-40 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was >10, the participant needed to be seen by a physician for further testing to determine if they had COPD.
Measured: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：SGRQ
The evaluation content consists of three parts: respiratory symptoms, activity ability, and disease impact. The questionnaire is calculated using SGRQ software, and the symptom score, activity score, impact score, and total score are obtained separately. The score fluctuates between 0-100, and the quality of life is negatively correlated with the score.
Measured: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：Forced expiratory volume in the first second
FEV1 will be applied to assess pulmonary function
Measured: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced Vital Capacity
FVC will be applied to assess pulmonary function
Measured: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced expiratory volume in the first Second Percentage of predicted value
FEV1% will be applied to assess pulmonary function
Measured: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Maximal Mid-Expiratory Flow
MMEF will be applied to assess pulmonary function
Measured: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced expiratory flow at 50% of FVC exhaled
FEF50% will be applied to assess pulmonary function
Measured: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced expiratory flow at 75% of FVC exhaled
FEF75% will be applied to assess pulmonary function
Measured: Before treatment, at weeks 52, 104, and 156 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmoriary Disease (COPD)Studies 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
- 2,312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Qingdao Municipal Hospital of Traditional Chinese Medicine, Henan Lingrui Pharmaceutical Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691802
- Sponsor's protocol ID
- Chronic Airway Diseases
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Reducing Recurrent Attacks of Chronic Airway Diseases (asthma, Chronic Obstructive Pulmonary Disease) with Shu Fei Tie Based on "winter Disease Being Cared in Summer"
- ClinicalTrials.gov ID
- NCT06691802
- Acronym / sponsor ID
- Chronic Airway Diseases
- Keywords
- Chronic Obstructive Pulmoriary Disease, Asthma, Shu Fei Tie, Winter disease being cared in summer, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,312 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Qingdao Municipal Hospital of Traditional Chinese Medicine, Henan Lingrui Pharmaceutical Co., Ltd
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 15 Nov 2024 (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.
Conduct a multi-center, large-sample, randomized controlled clinical study of "winter disease being cared in summer" with Shu Fei Tie prevent recurrence of Asthma and COPD, scientifically evaluate the clinical efficacy and safety of Shu Fei Tie in reducing the recurrence of chronic airway diseases, identify target population, clarify the mechanism of efficacy, and establish a prevention and treatment technology plan for Shu Fei Tie to reduce the recurrence of chronic airway diseases.
Detailed description
Asthma and Chronic obstructive pulmonary disease (COPD) are the most common chronic airway diseases, and their recurrent episodes or acute exacerbations are the main reasons for the decline in patients' quality of life and heavy economic burden. Based on the of "winter disease being cared in summer", traditional Chinese medicine (TCM) has a long history and wide application in preventing and treating the recurrence of chronic air diseases, with obvious advantages of combining TCM and Western medicine. However, there is a lack of integrated TCM and Western medicine technical schemes for chronic airway based on high-level evidence-based evidence. The Shu Fei Tie developed by our project team is a medical institution preparation that has been used clinically for a long. Therefore, this study conducted a multi-center, large-sample, randomized controlled clinical study of the Shu Fei Tie to prevent the recurrence of asthma and COPD. The study subjects were patients in the remission period of asthma (1332 cases) and the stable period of COPD (980 cases) On the basis of treatment guided by the guidelines, the experimental group was given the Shu Fei Tie, and the control group was given a placebo of theu Fei Tie. The treatment started 10 days before the " the first Fu" and was conducted every 10 days, A total of 5 times, Each treatment lasted 6-8 hours, and the follow-up period was 45 weeks, for a total of 3 cycles (3 years). The outcome indicators were the number of acute attacks per year for asthma and the number of acute exacerbations per year for COPD. The secondary outcome indicators for asthma included Asthma Control Test (ACT) score, the Asthma Control Questionnaire (ACQ), and the Asthma Quality of Life Questionnaire (AQLQ). For COPD, the secondary outcome indicators included clinical symptom scores and lung function. This study scientifically evaluated the clinical efficacy and safety of the Shu Fei Tie reducing the recurrence of chronic airway diseases, identified the advantageous population, elucidated the mechanism of efficacy, and established a technical scheme for preventing and treating the recurrence of chronic airway diseases with the Shu Fei Tie.
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 |
|---|---|---|
| Shu Fei Tie group for Asthma/COPD | Experimental | Drug: Shu Fei TiePatients in the Asthma/COPD experimental group were treated with Shu Fei Tie |
| Shu Fei Tie Placebo group for Asthma/COPD | Placebo comparator | Drug: Shu Fei Tie placeboPatients in the Asthma/COPD experimental group were treated with Shu Fei Tie Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meets the diagnostic criteria for asthma/COPD(Group E in the GOLD classification); ② Age range from18 years to 80 years(asthma) and 40 yesrs to 80 years(COPD);
Key exclusion criteria (4 listed)
- Patients with other pulmonary diseases (lung abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis，etc);
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 |
|---|---|---|
| Shu Fei TieOptimize the extraction process and matrix formulation, and combine the use of traditional Chinese medicine volatile oil and chemical transdermal enhancers to develop adermal patch（Shu Fei Tie） | Drug | Shu Fei Tie group for Asthma/COPD |
| Shu Fei Tie placeboShu Fei Tie Placebos are made using substances without active drug ingredients, following the same preparation procedures | Drug | Shu Fei Tie Placebo group for Asthma/COPD |
Primary outcome
Asthma part：Number of acute attacks per year
Time frame: Count once a year for three consecutive years
Record the number of acute attacks per year for each patient, and evaluate the effect of the lung-clearing patch on reducing the number of acute attacks
COPD part：The number of acute exacerbations per year
Time frame: Count once a year for three consecutive years
Record the number of acute exacerbations in patients per year to evaluate the treatment effect of Shu Fei Tie on patients.
COPD part：the interval between successive acute exacerbations
Time frame: at weeks 13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)，Until the first acute exacerbation occurs
Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
COPD part:the number of rehospitalizations within a year
Time frame: Count once a year until the end of the 3-year cycle
Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
20 secondary outcomes
Asthma part：Asthma Control Test
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Asthma Control Questionnaire
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Asthma Quality of Life Questionnaire
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Frequency of anti-inflammatory and analgesic use
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Disease Control Rate
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：readmission rate
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
Asthma part：Forced expiratory volume in the first second
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
Asthma part：Peak expiratory flow
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
Asthma part：Fractional exhaled nitric oxide
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
Asthma part：clinical symptoms and signs questionnaire
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：clinical symptoms and signs questionnaire
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：mMRC
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：CAT
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：SGRQ
Time frame: at weeks 0,13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)
COPD part：Forced expiratory volume in the first second
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced Vital Capacity
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced expiratory volume in the first Second Percentage of predicted value
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Maximal Mid-Expiratory Flow
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced expiratory flow at 50% of FVC exhaled
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
COPD part：Forced expiratory flow at 75% of FVC exhaled
Time frame: Before treatment, at weeks 52, 104, and 156 of treatment
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 15 Nov 2024.
Related trials for Chronic Obstructive Pulmoriary Disease (COPD)
Not yet recruitingObservational study
Respiratory Disease Cohort Studies of Chinese Medicine for COPD(RESEARCH-COPD)
Chronic Obstructive Pulmoriary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shu Fei Tie in people with Chronic Obstructive Pulmoriary Disease (COPD) and Asthma, run by Henan University of Traditional Chinese Medicine at 1 site in China.
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 2 inclusion and 4 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 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 suyun Li PhD (13938415502, lisuyun2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma part：Number of acute attacks per year (time frame: Count once a year for three consecutive years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.