Clinical trial
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
Name
2022-5-26-QFS
Description
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.
Trial arms
Trial start
2022-06-06
Estimated PCD
2023-12-01
Trial end
2024-07-01
Status
Recruiting
Treatment
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.
Arms:
Experimental group
Other names:
H37023540
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).
Arms:
Control group
Size
134
Primary endpoint
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
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 134, 'type': 'ESTIMATED'}}
Updated at
2023-08-21
1 organization
1 product
1 indication
Organization
Qianfoshan HospitalProduct
Staphylococcus and NeisseriaIndication
Bronchiectasis