Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease

Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease: A Multi-center, Prospective Study

This is a multi-center, prospective study. This study aims to investigate the incidence of acute exacerbation within 12 months, as well as the safety of Staphylococcus and Neisseria Tablets on patients with chronic obstructive pulmonary disease (COPD). In addition, this study investigates the improvement of hospitalization, improvement of pulmonary function, improvement of symptoms, and the use of anti-Infective drugs among COPD patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Staphylococcus and Neisseria Tablets

Detailed Description

A total of 750 eligible COPD patients were enrolled, and were randomly divided into experimental group and control group with a ratio of 2:1. Experimental group will receive Staphylococcus and Neisseria Tablets (0.3mg/tablet) and standard care. Drug administration is 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months. Control group will receive standard care without interventions.

All participants have to sign informed consent. After baseline (V0/V1), participants will be followed up for 12 months with four follow-up visits at 4 weeks ± 14d (V2), 13 weeks ± 14d (V3), 26 weeks ± 14d (V4), and 52 weeks ± 14d (V5). Among them, V2 can be phone interview.

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yongchang Sun, M.D.; Phone Number: 86-15611963697; Email: suny@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-80 years, males and females.
• Clinical diagnosis of COPD, defined as FEV1/FVC<70% after inhaling bronchodilators.
• At least 1 moderate to severe acute exacerbation of COPD in the past year.
• Patient or their legal agent sign informed consent with a date after understanding the purpose and procedures of the research, and be willing to participate in the study.

Exclusion Criteria:

• Patients with active pulmonary tuberculosis, asthma, or uncontrolled advanced malignant tumors; or after partial, lobar, or total pneumonectomy.
• Patients with acute cardio cerebral vascular disease such as acute myocardial infarction, acute stroke and acute heart failure.
• Patients with liver failure or renal failure and need blood purification treatment.
• Patients with rheumatic diseases and autoimmune diseases.
• Have participated or currently in interventional clinical trials within 30 days.
• Patients with previous (within 3 months before signing the informed consent) or current use of immunomodulatory drugs (including thymosin, thymosin, interferon, transfer factor, BCG vaccine polysaccharide, and any kind of bacterial extract such as Biostim, pneumonia vaccine, and influenza vaccine).
• Currently pregnant or breast-feeding women, or those who have fertility but cannot take contraceptive measures during the study period.
• Other conditions that are not suitable for the trials according to investigator's judgement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Staphylococcus and Neisseria group; Experimental group will receive Staphylococcus and Neisseria Tablets (0.3mg/tablet) and standard care. Administration Staphylococcus and Neisseria is 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months.	Drug: Staphylococcus and Neisseria Tablets; Staphylococcus and Neisseria tablets is used as an adjuvant treatment drug for respiratory disease in acute attack period, such as chronic tracheitis, bronchitis and various types of colds. It has been proved to effectively shorten the course of disease. In this study, Staphylococcus and Neisseria tablets will be administered with 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months according to clinicians.
No Intervention: Standard care group; Standard care based on clinical experience without interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AECOPD (Acute exacerbation COPD)	Incidence of AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).; Mild：No respiratory failure. Respiratory rate 20-30 times/min; no use of ventilator or change in mental state; fraction of inspiration O2 (FiO2) improves after supplemental oxygen; no increase in partial pressure of CO2 in artery (PaCO2).; Moderate：Acute respiratory failure but not life threatening. Respiratory rate > 30 times/min; use of ventilator or change in mental state; FiO2>35% after supplemental oxygen, improved hypoxemia; hypercapnia, PaCO2 increases from baseline or increases to 50-60mmHg.; Severe：Acute respiratory failure and life threatening. Respiratory rate > 30 times/min; use of ventilator; acute changes in mental state; FiO2>45% after supplemental oxygen, no improvement in hypoxemia; PaCO2 increases by > 60mmHg from baseline or acidosis.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate or severe AECOPD	Incidence of moderate or severe AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).	12 months
Change in frequency of AECOPD	Change in frequency of AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).	12 months
Hospitalization due to severe AECOPD	Hospitalization due to severe AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version). Hospitalization include ICU admission.	12 months
mMRC（modified Medical Research Council）	Changes in mMRC during the observation period. mMRC score a 5-point (0-4) scale, and higher grades indicate higher severity of dyspnea.	1 month, 3 months, 6 months, and 12 months
CAT（COPD Assessment Test）	Changes in CAT during the observation period. CAT score ranges from 0 to 40 points, and higher scores indicate higher symptom burden of COPD on patients.	1 month, 3 months, 6 months, and 12 months
TDI（Transition Dyspnea Index）	Changes in TDI during the observation period. TDI score ranges from -9 to 9 points, and higher scores indicate more significant improvements from baseline.	1 month, 3 months, 6 months, and 12 months
CET（Cough Evaluation Test）	Changes in CET during the observation period. CET score ranges from 5 to 25 points, and higher scores indicate higher cough severity.	1 month, 3 months, 6 months, and 12 months
Cough severity VAS（Visual Analog Scale）	Changes in VAS during the observation period. VAS a 100-mm linear scale ranging from "no cough" (0 mm) to "worst cough" (100 mm), and higher scores indicate higher cough severity.	1 month, 3 months, 6 months, and 12 months
Changes in the use of inhaled drugs	According to the medication administration record, any changes in the use of inhaled drugs during the observation period, including dosage, frequency, duration, etc.	1 month, 3 months, 6 months, and 12 months
Pulmonary function	Changes in pulmonary function during the observation period. Pulmonary function is evaluated by the ratio of forced expiratory volume in the first second (FEV1) to forced vital capacity (FVC) (FEV1/FVC)	6 months, and 12 months
Changes in the use of anti-infective drugs	According to the medication administration record, any changes in the use of ianti-infective drugs within 12 months, including dosage, frequency, duration, etc.	12 months
Adverse events	Occurrence of any Staphylococcus and Neisseria related adverse events during the study period.	12 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Yongchang Sun, M.D., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: YL20230221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No