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

Primary Purpose

Bronchiectasis

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Staphylococcus and Neisseria Tablets

On-demand treatment

About this trial

This is an interventional treatment trial for Bronchiectasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

Oral staphylococcus albicans tablet group.

On-demand treatment group

Outcomes

Primary Outcome Measures

Number of acute exacerbations

Time to first exacerbation

Rate of readmission at 12 months

Number of acute exacerbations

Secondary Outcome Measures

Change from Baseline Life Quality Score at 12 months

Change from Baseline FEV1 at 12 months

Change from Baseline FEV1/FVC at 12 months

Change from Baseline FEV1 % predicted at 12 months

Change from Baseline sputum volume at 12 months

Change from Baseline percentage of patients with yellow purulent sputum at 12 months

Change from Baseline percentage of patients with immune dysfunction at 12 months

Change from Baseline of percentage of patients with positive sputum culture

Number of Participants with adverse reactions

Full Information

NCT ID

NCT05407792

First Posted

May 26, 2022

Last Updated

August 17, 2023

Sponsor

Qianfoshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05407792

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 6, 2022 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Qianfoshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchiectasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Oral staphylococcus albicans tablet group.

Arm Title

Control group

Arm Type

Other

Arm Description

On-demand treatment group

Intervention Type

Drug

Intervention Name(s)

Staphylococcus and Neisseria Tablets

Other Intervention Name(s)

H37023540

Intervention Description

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

Other

Intervention Name(s)

On-demand treatment

Intervention Description

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).

Primary Outcome Measure Information:

Title

Number of acute exacerbations

Time Frame

Up to 12 months

Title

Time to first exacerbation

Time Frame

Up to 12 months

Title

Rate of readmission at 12 months

Time Frame

Up to 12 months

Title

Number of acute exacerbations

Time Frame

up to 6 months

Title

Number of acute exacerbations

Time Frame

Up to 3 months

Secondary Outcome Measure Information:

Title

Change from Baseline Life Quality Score at 12 months

Time Frame

Up to 12 months

Title

Change from Baseline FEV1 at 12 months

Time Frame

Up to 12 months

Title

Change from Baseline FEV1/FVC at 12 months

Time Frame

Up to 12 months

Title

Change from Baseline FEV1 % predicted at 12 months

Time Frame

Up to 12 months

Title

Change from Baseline sputum volume at 12 months

Time Frame

Up to 12 months

Title

Change from Baseline percentage of patients with yellow purulent sputum at 12 months

Time Frame

Up to 12 months

Title

Change from Baseline percentage of patients with immune dysfunction at 12 months

Time Frame

Up to 12 months

Title

Change from Baseline of percentage of patients with positive sputum culture

Time Frame

Up to 12 months

Title

Number of Participants with adverse reactions

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

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

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250014

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qian Qi, Doctor

Phone

+86 13706380314

qiqianqlh@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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