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

NCT05975788 | Unknown Phase 4

• 1 other identifier: YL20230221
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Moderate or severe AECOPD

  12 months

• Change in frequency of AECOPD

  12 months

• Hospitalization due to severe AECOPD

  12 months

• mMRC（modified Medical Research Council）

  1 month, 3 months, 6 months, and 12 months

• CAT（COPD Assessment Test）

  1 month, 3 months, 6 months, and 12 months

Study Arms (2)

Staphylococcus and Neisseria group

EXPERIMENTAL

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

Standard care group

NO INTERVENTION

Standard care based on clinical experience without interventions.

Interventions

Staphylococcus and Neisseria Tablets DRUG

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.

Staphylococcus and Neisseria group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yongchang Sun, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Sun, M.D.

CONTACT

86-15611963697; suny@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Respiratory Department

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 4, 2023
• Study Start: November 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)