A Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT06134063 | Unknown

• 1 other identifier: XFBD-AECOPD-001
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

Acute Exacerbation of Chronic Obstructive Pulmonary Disease; Xuanfei Baidu granule

Outcome Measures

Primary Outcomes (1)

• Treatment failure rate.

  Admission for acute exacerbation of COPD within 21 days after enrollment (excluding admission for reimbursement).

  within 21 days after enrollment

Secondary Outcomes (8)

• Duration of acute exacerbation of COPD in this episode.

  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.

  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.

  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.

  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.

  within 21 days after enrollment

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: Xuanfei Baidu granule

Control group

PLACEBO COMPARATOR

Drug: Xuanfei Baidu granule Placebo

Interventions

Xuanfei Baidu granule DRUG

Xuanfei Baidu granule will be administered twice daily for 7 days on the basis of basic treatment

Experimental group

Xuanfei Baidu granule Placebo DRUG

Xuanfei Baidu granule Placebo will be administered twice daily for 7 days on the basis of basic treatment

Control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

Central Study Contacts

Jingli Feng

CONTACT

18810535368; 20210941147@bucm.edu.cn

Cuiling Feng

CONTACT

15901341502; fengcuiling@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)