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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
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.
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).
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
RECRUITINGNumber of acute exacerbations
Time frame: Up to 12 months
Time to first exacerbation
Time frame: Up to 12 months
Rate of readmission at 12 months
Time frame: Up to 12 months
Number of acute exacerbations
Time frame: up to 6 months
Number of acute exacerbations
Time frame: Up to 3 months
Change from Baseline Life Quality Score at 12 months
Time frame: Up to 12 months
Change from Baseline FEV1 at 12 months
Time frame: Up to 12 months
Change from Baseline FEV1/FVC at 12 months
Time frame: Up to 12 months
Change from Baseline FEV1 % predicted at 12 months
Time frame: Up to 12 months
Change from Baseline sputum volume at 12 months
Time frame: Up to 12 months
Change from Baseline percentage of patients with yellow purulent sputum at 12 months
Time frame: Up to 12 months
Change from Baseline percentage of patients with immune dysfunction at 12 months
Time frame: Up to 12 months
Change from Baseline of percentage of patients with positive sputum culture
Time frame: Up to 12 months
Number of Participants with adverse reactions
Time frame: Up to 12 months
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