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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Cystic fibrosis;
Immunodeficiency, allergic bronchopulmonary aspergillosis, etc.;
Traction bronchiectasis caused by severe emphysema or advanced pulmonary fibrosis;
Still smoking;
Trial design
Parallel
Treatments tested in this trial
Staphylococcus and Neisseria Tablets
Drug0.3 mg/ tablet, 4 tablets each time, 3 times a day (Shandong Qilu Pharmaceutical Co., LTD.), the course of treatment was more than 3 months.
On-demand treatment
Other interventionAt 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).
Treatment groups
Trial outcomes
Primary outcomes
Number of acute exacerbations
Time to first exacerbation
Rate of readmission at 12 months
Number of acute exacerbations
Secondary outcomes
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
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