Clinical trial NCT06134063: A Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Keywords: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Xuanfei Baidu granule
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 375
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Treatment failure rate.
timeFrame: within 21 days after enrollment
Secondary outcomes:
measure: Duration of acute exacerbation of COPD in this episode.
timeFrame: within 21 days after enrollment
measure: 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.
timeFrame: days 7, 14, and 21 after enrollment
measure: 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.
timeFrame: on days 7, 14, and 21 after enrollment
measure: Change in the mMRC score after treatment compared to baseline: Assessing the severity of breathlessness on days 7, 14, and 21 after enrollment.
timeFrame: on days 7, 14, and 21 after enrollment
measure: 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.
timeFrame: within 21 days after enrollment
measure: Change in the Clinical Symptom Score after treatment compared to baseline: Observing clinical symptom scores on days 7, 14, and 21 after enrollment.
timeFrame: on days 7, 14, and 21 after enrollment
measure: Incidence of clinical abnormalities in laboratory examination and electrocardiogram.
timeFrame: within 21 days after enrollment
measure: Incidence of adverse events and serious adverse events.
timeFrame: within 21 days after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References: