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

NCT05407792 | Recruiting

• 1 other identifier: 2022-5-26-QFS
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (5)

• Number of acute exacerbations

  Up to 12 months

• Time to first exacerbation

  Up to 12 months

• Rate of readmission at 12 months

  Up to 12 months

• Number of acute exacerbations

  up to 6 months

• Number of acute exacerbations

  Up to 3 months

Secondary Outcomes (9)

• Change from Baseline Life Quality Score at 12 months

  Up to 12 months

• Change from Baseline FEV1 at 12 months

  Up to 12 months

• Change from Baseline FEV1/FVC at 12 months

  Up to 12 months

• Change from Baseline FEV1 % predicted at 12 months

  Up to 12 months

• Change from Baseline sputum volume at 12 months

  Up to 12 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Oral staphylococcus albicans tablet group.

Drug: Staphylococcus and Neisseria Tablets

Control group

OTHER

On-demand treatment group

Other: On-demand treatment

Interventions

Staphylococcus and Neisseria Tablets 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.

Also known as: H37023540

Experimental group

On-demand treatment 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).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bronchiectasis diagnosed by clinical manifestations and chest HRCT according to the diagnostic criteria for bronchiectasis;
• Patients with idiopathic or post-infectious bronchiectasis;
• years 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

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

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 7, 2022
• Study Start: June 6, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

CN (1)