NCT05543343

Staphylococcus and Neisseria Tablets in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease.

Evaluating the Efficacy and Safety of Staphylococcus and Neisseria Tablets in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 495 (estimated)
• Sponsor: Qu Yiqing · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It is planned to enroll 495 acute exacerbation of chronic obstructive pulmonary disease patients, and they will be randomly assigned to the high-dose test group, normal dose test group or control group at a ratio of 1:1:1, with 165 patients in each group. The course of treatment is 90 days, and the total follow-up time is one year. The purpose of the study is to evaluate the effectiveness and safety of different doses of bacterial lysates (Staphylococcus and Neisseria Tablets) in the treatment of acute exacerbation of chronic obstructive pulmonary disease.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	High dose or normal dose staphylococcus albicans	8 staphylococcus albicans tablets(0.3 mg) 3 times daily or 4 staphylococcus albicans tablets(0.3 mg)+4 placebo tablets 3 times daily
DRUG	Placebo	8 placebo tablets 3 times daily

Timeline

• Start date: 2022-01-05
• Primary completion: 2023-03-01
• Completion: 2023-08-01
• First posted: 2022-09-16
• Last updated: 2022-09-16

Locations

1 site across 1 country: China