---
title: Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease
nct_id: NCT05975788
overall_status: UNKNOWN
phase: PHASE4
sponsor: Peking University Third Hospital
study_type: INTERVENTIONAL
primary_condition: Chronic Obstructive Pulmonary Disease
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05975788.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05975788"
ct_last_update_post_date: 2023-11-18
last_seen_at: "2026-05-12T07:01:28.114Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease

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

**NCT ID:** [NCT05975788](https://clinicaltrials.gov/study/NCT05975788)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 750
- **Lead Sponsor:** Peking University Third Hospital
- **Conditions:** Chronic Obstructive Pulmonary Disease
- **Start Date:** 2023-11
- **Completion Date:** 2025-07
- **CT.gov Last Update:** 2023-11-18

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.
- **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.

## Primary Outcomes

- **AECOPD (Acute exacerbation COPD)** _(time frame: 12 months)_ — 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.

## Secondary Outcomes

- **Moderate or severe AECOPD** _(time frame: 12 months)_
- **Change in frequency of AECOPD** _(time frame: 12 months)_
- **Hospitalization due to severe AECOPD** _(time frame: 12 months)_
- **mMRC（modified Medical Research Council）** _(time frame: 1 month, 3 months, 6 months, and 12 months)_
- **CAT（COPD Assessment Test）** _(time frame: 1 month, 3 months, 6 months, and 12 months)_
- **TDI（Transition Dyspnea Index）** _(time frame: 1 month, 3 months, 6 months, and 12 months)_
- **CET（Cough Evaluation Test）** _(time frame: 1 month, 3 months, 6 months, and 12 months)_
- **Cough severity VAS（Visual Analog Scale）** _(time frame: 1 month, 3 months, 6 months, and 12 months)_
- **Changes in the use of inhaled drugs** _(time frame: 1 month, 3 months, 6 months, and 12 months)_
- **Pulmonary function** _(time frame: 6 months, and 12 months)_
- **Changes in the use of anti-infective drugs** _(time frame: 12 months)_
- **Adverse events** _(time frame: 12 months)_

## Locations (1)

- Peking University Third Hospital, Beijing, Beijing Municipality, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.peking university third hospital|beijing|beijing municipality|china` — added _(2026-05-12)_

---

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