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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis
• Intervention / Treatment: Drug: Staphylococcus and Neisseria Tablets; Other: On-demand treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
      • Contact: Qian Qi, Doctor; Phone Number: +86 13706380314; Email: qiqianqlh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Oral staphylococcus albicans tablet group.	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 Names: H37023540
Other: Control group; On-demand treatment group	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Change from Baseline percentage of patients with yellow purulent sputum at 12 months	Up to 12 months
Change from Baseline percentage of patients with immune dysfunction at 12 months	Up to 12 months
Change from Baseline of percentage of patients with positive sputum culture	Up to 12 months
Number of Participants with adverse reactions	Up to 12 months

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: 2022-5-26-QFS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No