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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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Peking University Third Hospital
Beijing, Beijing Municipality, China
Start Date
November 1, 2023
Primary Completion Date
February 1, 2025
Completion Date
July 1, 2025
Last Updated
November 18, 2023
750
ESTIMATED participants
Staphylococcus and Neisseria Tablets
DRUG
Lead Sponsor
Peking University Third Hospital
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
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