NCT05407792

Efficacy and Safety of Long-term Oral Staphylococcus Albicans Tablets in Patients With Bronchiectasis

Efficacy and Safety of Long-term Oral Administration of Staphylococcus Albicans Tablets in Patients With Acute Exacerbation and Stable Bronchiectasis: a Multicenter, Prospective Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to investigate whether long-term oral administration of Staphylococcus albicans tablets can significantly reduce the number of acute exacerbations in patients with bronchiectasis. Secondary objective is to explore whether long-term oral administration of Staphylococcus albicans tablets can reduce the risk of hospitalization in patients with bronchiectasis and whether it can improve the quality of life of patients. Other purpose is to explore the regulatory effect of long-term oral administration of Staphylococcus albicans tablets on the immune function of patients with bronchiectasis.

Detailed description

Bronchiectasis is a chronic airway purulent disease. The four factors of "vicious circle" play an important role in the occurrence, development and prognosis of bronchiectasis. Attempts to breaks the vicious circle may be beneficial to reduce the acute exacerbation of bronchiectasis. The main ingredients of Staphylococcus albicans tablets are the inactivated cells of Staphylococcus albus, Catarella catarrhalis and Bacillus subtilis. It may be beneficial to improve the non-specific immunity of patients and the specific immune function of respiratory mucosa, and reduce airway mucus secretion and secretion retention. There is not yet sufficient clinical evidence to support the immune function regulation and related efficacy of patients. Therefore, the efficacy of long-term oral administration of Staphylococcus albicans tablets in patients with bronchiectasis needs to be further confirmed by clinical studies.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	Staphylococcus and Neisseria Tablets	0.3 mg/ tablet, 4 tablets each time, 3 times a day (Shandong Qilu Pharmaceutical Co., LTD.), the course of treatment was more than 3 months.
OTHER	On-demand treatment	At the time of enrollment, patients with acute exacerbation of bronchiectasis were given routine treatment. For patients with stable bronchiectasis at the time of enrollment, they are treated as needed (that is, according to the needs of the disease, receive corresponding treatment).

Timeline

• Start date: 2022-06-06
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2022-06-07
• Last updated: 2025-02-28

Locations

1 site across 1 country: China