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

NCT ID: NCT05407792

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

Oral staphylococcus albicans tablet group.

Group Type: EXPERIMENTAL

Staphylococcus and Neisseria Tablets

Intervention Type: DRUG

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.

Control group

On-demand treatment group

Group Type: OTHER

On-demand treatment

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: DRUG

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).

Intervention Type: OTHER

Other Intervention Names

H37023540

Eligibility Criteria

Inclusion Criteria

• Patients with bronchiectasis diagnosed by clinical manifestations and chest HRCT according to the diagnostic criteria for bronchiectasis;

• Patients with idiopathic or post-infectious bronchiectasis;

• 18years old;

• Patients should have at least 2 acute exacerbations within 1 year before enrollment;

• Patients in either acute exacerbation or stable period can be included.

Exclusion Criteria

• Cystic fibrosis;

• Immunodeficiency, allergic bronchopulmonary aspergillosis, etc.;

• Traction bronchiectasis caused by severe emphysema or advanced pulmonary fibrosis;

• Still smoking;

• Complicated with asthma or chronic obstructive disease Lung;

• Patients with severe cardiovascular disease, severe neurological disease, or severe liver or kidney damage;

• Malignant tumors;

• Allergy to Staphylococcus albicans tablets;

• Patients with a history of gastric ulcer or intestinal malabsorption;

• Pregnant or lactating women;

• patients with poor compliance;

• previous (within 6 months before the start of the study) or concurrently taking immunostimulating drugs (including thymosin, interferon, transfer factor, BCG, pneumonia vaccine and any kind of bacteria Extracts, such as Biostim, except for influenza vaccine) or immunosuppressants;

• Patients who are participating in or have participated in interventional clinical trials within 3 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qian Qi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qian Qi, Doctor

Role: primary

qiqianqlh@163.com

+86 13706380314

Other Identifiers

2022-5-26-QFS

Identifier Type: -

Identifier Source: org_study_id