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

Peking University

Status and phase: Not yet enrolling; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Staphylococcus and Neisseria Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05975788

YL20230221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Staphylococcus and Neisseria group

Experimental group

Description:

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.

Treatment:

Drug: Staphylococcus and Neisseria Tablets

Standard care group

No Intervention group

Description:

Standard care based on clinical experience without interventions.