Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT06134063
A Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing Xuanfei Baidu granule in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial. This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- Xuanfei Baidu granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 1 siteChina
- Study dates
- Nov 2023to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 40 and 80 years old, including 40 and 80 years old, regardless of gender;
- Clinical records of traceable of the chronic obstructive pulmonary disease history records, after bronchodilator FEV1 less than 80% of the expected value;
- Comply with the definition of COPD acute exacerbations and with mild and moderate severity assessment;
- Symptoms of AECOPD time less than 48 h;
- "Shiduyufei" diagnostic standard;
- Volunteered for the study, signed informed consent, is willing to cooperate with the visitor.
Who cannot join
- Patients showing signs of hospitalization;
- With respiratory system diseases other than the AECOPD (for example, pneumonia, bronchiectasis, active tuberculosis, pneumothorax, pleural effusion, pulmonary embolism, or affect the respiratory movement function of neuromuscular diseases, etc.);
- Patients with severe basic diseases (for example, uncontrolled hypertension diabetes and complicated with heart failure (NYHA class IV), severe arrhythmia, acute coronary syndrome, hemodynamic instability, long-term use of immunosuppressive agents, etc.);
- With primary disease such as tumor or blood system;
- With severe liver disease (cirrhosis, portal hypertension, varices bleeding) or renal insufficiency;
- Pregnant women and breastfeeding mothers, those suspected of being pregnant, or women of childbearing age at risk of pregnancy who have not taken effective contraceptive measures;
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- Dementia, mental disorders, such as unable to read or understand the research content, the information collection;
- With drug allergy;
- 3 months prior to screening for other interventional clinical research and the research data information;
- Within 1 week before screening been oral Chinese medicine or other proprietary Chinese medicine treatment;
- Patient refused to sign a consent form, or estimate adherence is poor, or follow-up possibilities is poor.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Cuiling Feng, 15901341502, fengcuiling@sina.com
About this study
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial.
This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. On the basis of basic treatment, one group will receive Xuanfei Baidu granule, while the other group will receive Xuanfei Baidu granule placebo, with one sachet in the morning and one in the evening, for a duration of 7 days. Visits will be conducted on days 7, 14, and 21 after enrollment.
If any participant experiences an acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization during the treatment period, they will continue taking the medication until the 7-day course is completed. In case of a COPD exacerbation hospitalization event during the study, hospital admission date, duration of hospitalization, and the treatment regimen during hospitalization will be recorded.
Read the detailed description
This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial.
This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. On the basis of basic treatment, one group will receive Xuanfei Baidu granule, while the other group will receive Xuanfei Baidu granule placebo, with one sachet in the morning and one in the evening, for a duration of 7 days. Visits will be conducted on days 7, 14, and 21 after enrollment.
If any participant experiences an acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization during the treatment period, they will continue taking the medication until the 7-day course is completed. In case of a COPD exacerbation hospitalization event during the study, hospital admission date, duration of hospitalization, and the treatment regimen during hospitalization will be recorded.
- Being tested
- Xuanfei Baidu granule, Xuanfei Baidu granule Placebo
- Keywords
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Xuanfei Baidu granule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuanfei Baidu granuleDrug
Xuanfei Baidu granule will be administered twice daily for 7 days on the basis of basic treatment
Xuanfei Baidu granule PlaceboDrug
Xuanfei Baidu granule Placebo will be administered twice daily for 7 days on the basis of basic treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Xuanfei Baidu granule |
| Control group | Placebo comparator | Not described Receives: Drug: Xuanfei Baidu granule Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure rate.
Admission for acute exacerbation of COPD within 21 days after enrollment (excluding admission for reimbursement).
Measured: within 21 days after enrollment
Secondary outcomes (8)
Duration of acute exacerbation of COPD in this episode.
Duration of acute exacerbation of COPD in this episode.
Measured: within 21 days after enrollment
Change in the Dyspnea Visual Analog Scale (VAS) score after treatment compared to baseline: Assessing the severity of breathlessness on days 7, 14, and 21 after enrollment.
The minimum and maximum values for VAS scores are 0 and 10. A higher score indicates a worse outcome.
Measured: days 7, 14, and 21 after enrollment
Change in the COPD Assessment Test (CAT) score after treatment compared to baseline: Assessing the degree of health impairment on days 7, 14, and 21 after enrollment.
The CAT score ranges from 0 to 40. Patients scoring 0 to 10 points are classified as having "mild impact" of COPD, 11 to 20 points as "moderate impact," 21 to 30 points as "severe impact," and 31 to 40 points as "very severe impact.
Measured: on days 7, 14, and 21 after enrollment
Change in the mMRC score after treatment compared to baseline: Assessing the severity of breathlessness on days 7, 14, and 21 after enrollment.
The minimum and maximum values for mMRC scores are 0 and 4. A higher score indicates a worse outcome.
Grade 0 means I only get breathless with strenuous exercise; Grade 1 means I get short of breath when hurrying on the level or walking up a slight hill; Grade 2 means I walk slower than people of the same age on the level because of breathlessness, or I have to stop for rest when walking at my own pace on the level; Grade 3 means I stop for breath after walking about 100 meters or after a few minutes on the level; Grade 4 means I am too breathless to leave the house or I am breathless when dressing or undressing.
Measured: on days 7, 14, and 21 after enrollment
Change in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) score after treatment compared to baseline: Assessing daily COPD exacerbation events within 21 days after enrollment.
The minimum and maximum values for EXACT scores are 0 and 70. A higher score indicates a worse outcome.
Measured: within 21 days after enrollment
Change in the Clinical Symptom Score after treatment compared to baseline: Observing clinical symptom scores on days 7, 14, and 21 after enrollment.
The clinical symptom score is based on the individual symptoms of the patient graded as none, mild, moderate, or severe, with scores of 0, 1, 2, and 3, respectively. The scores for each individual symptom are then added up to obtain the total score, ranging from a minimum of 0 to a maximum of 27. A higher total score indicates a more severe outcome.
Measured: on days 7, 14, and 21 after enrollment
Incidence of clinical abnormalities in laboratory examination and electrocardiogram.
Incidence of clinical abnormalities in laboratory examination and electrocardiogram.
Measured: within 21 days after enrollment
Incidence of adverse events and serious adverse events.
Incidence of adverse events and serious adverse events.
Measured: within 21 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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, Care provider, Investigator
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cuiling Feng, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134063
- Sponsor's protocol ID
- XFBD-AECOPD-001
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06134063
- Acronym / sponsor ID
- XFBD-AECOPD-001
- Keywords
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Xuanfei Baidu granule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 18 Nov 2023 (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.
This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial.
This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. On the basis of basic treatment, one group will receive Xuanfei Baidu granule, while the other group will receive Xuanfei Baidu granule placebo, with one sachet in the morning and one in the evening, for a duration of 7 days. Visits will be conducted on days 7, 14, and 21 after enrollment.
If any participant experiences an acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization during the treatment period, they will continue taking the medication until the 7-day course is completed. In case of a COPD exacerbation hospitalization event during the study, hospital admission date, duration of hospitalization, and the treatment regimen during hospitalization will be recorded.
Detailed description
This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial.
This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. On the basis of basic treatment, one group will receive Xuanfei Baidu granule, while the other group will receive Xuanfei Baidu granule placebo, with one sachet in the morning and one in the evening, for a duration of 7 days. Visits will be conducted on days 7, 14, and 21 after enrollment.
If any participant experiences an acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization during the treatment period, they will continue taking the medication until the 7-day course is completed. In case of a COPD exacerbation hospitalization event during the study, hospital admission date, duration of hospitalization, and the treatment regimen during hospitalization will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Xuanfei Baidu granule |
| Control group | Placebo comparator | Drug: Xuanfei Baidu granule Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 40 and 80 years old, including 40 and 80 years old, regardless of gender;
- Clinical records of traceable of the chronic obstructive pulmonary disease history records, after bronchodilator FEV1 less than 80% of the expected value;
- Comply with the definition of COPD acute exacerbations and with mild and moderate severity assessment;
- Symptoms of AECOPD time less than 48 h;
- "Shiduyufei" diagnostic standard;
Key exclusion criteria (11 listed)
- Patients showing signs of hospitalization;
- With respiratory system diseases other than the AECOPD (for example, pneumonia, bronchiectasis, active tuberculosis, pneumothorax, pleural effusion, pulmonary embolism, or affect the respiratory movement function of neuromuscular diseases, etc.);
- Patients with severe basic diseases (for example, uncontrolled hypertension diabetes and complicated with heart failure (NYHA class IV), severe arrhythmia, acute coronary syndrome, hemodynamic instability, long-term use of immunosuppressive agents, etc.);
- With primary disease such as tumor or blood system;
- With severe liver disease (cirrhosis, portal hypertension, varices bleeding) or renal insufficiency;
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 |
|---|---|---|
| Xuanfei Baidu granuleXuanfei Baidu granule will be administered twice daily for 7 days on the basis of basic treatment | Drug | Experimental group |
| Xuanfei Baidu granule PlaceboXuanfei Baidu granule Placebo will be administered twice daily for 7 days on the basis of basic treatment | Drug | Control group |
Primary outcome
Treatment failure rate.
Time frame: within 21 days after enrollment
Admission for acute exacerbation of COPD within 21 days after enrollment (excluding admission for reimbursement).
8 secondary outcomes
Duration of acute exacerbation of COPD in this episode.
Time frame: within 21 days after enrollment
Change in the Dyspnea Visual Analog Scale (VAS) score after treatment compared to baseline: Assessing the severity of breathlessness on days 7, 14, and 21 after enrollment.
Time frame: days 7, 14, and 21 after enrollment
Change in the COPD Assessment Test (CAT) score after treatment compared to baseline: Assessing the degree of health impairment on days 7, 14, and 21 after enrollment.
Time frame: on days 7, 14, and 21 after enrollment
Change in the mMRC score after treatment compared to baseline: Assessing the severity of breathlessness on days 7, 14, and 21 after enrollment.
Time frame: on days 7, 14, and 21 after enrollment
Change in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) score after treatment compared to baseline: Assessing daily COPD exacerbation events within 21 days after enrollment.
Time frame: within 21 days after enrollment
Change in the Clinical Symptom Score after treatment compared to baseline: Observing clinical symptom scores on days 7, 14, and 21 after enrollment.
Time frame: on days 7, 14, and 21 after enrollment
Incidence of clinical abnormalities in laboratory examination and electrocardiogram.
Time frame: within 21 days after enrollment
Incidence of adverse events and serious adverse events.
Time frame: within 21 days after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xuanfei Baidu granule in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Peking University People's Hospital 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingli Feng (18810535368, 20210941147@bucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure rate. (time frame: within 21 days after enrollment). 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 18 Nov 2023.