RECRUITINGINTERVENTIONAL

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

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Cystic fibrosis; - weakened immune system, 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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

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).

Locations (1)

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

Jinan, Shandong, China