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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
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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
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

First Posted
May 26, 2022
Last Updated
August 17, 2023
Sponsor
Qianfoshan Hospital
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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
No
Studies a U.S. FDA-regulated Device Product
No

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
No
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
Email
qiqianqlh@163.com

12. IPD Sharing Statement

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

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