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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.
Details
| Lead sponsor | Peking University Third Hospital |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 750 |
| Start date | 2023-11 |
| Completion | 2025-07 |
Conditions
- Chronic Obstructive Pulmonary Disease
Interventions
- Staphylococcus and Neisseria Tablets
Primary outcomes
- AECOPD (Acute exacerbation COPD) — 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.
Countries
China