Staphylococcus and Neisseria Tablets in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease.

Study Overview
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Brief Summary
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It is planned to enroll 495 acute exacerbation of chronic obstructive pulmonary disease patients, and they will be randomly assigned to the high-dose test group, normal dose test group or control group at a ratio of 1:1:1, with 165 patients in each group. The course of treatment is 90 days, and the total follow-up time is one year. The purpose of the study is to evaluate the effectiveness and safety of different doses of bacterial lysates (Staphylococcus and Neisseria Tablets) in the treatment of acute exacerbation of chronic obstructive pulmonary disease.

Official Title
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Evaluating the Efficacy and Safety of Staphylococcus and Neisseria Tablets in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease.

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: High dose or normal dose staphylococcus albicans
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 75 years old (including both ends), gender is not limited； Clinically diagnosed as chronic obstructive pulmonary disease (have a lung function test in the past year, after inhaling 400ug of salbutamol for 15 to 30 minutes, FEV1/FVC<0.70); The patient was in the acute exacerbation of chronic obstructive pulmonary disease at the time of enrollment (the patient's cough, sputum expectoration, and dyspnea exceeded any abnormal variation); At least one exacerbation of chronic obstructive pulmonary disease in the past year; The patient (or his legal representative) must sign and date the informed consent form, indicating that he/she understands the purpose of the study and the procedures to be carried out, and is willing to participate in the study. Exclusion Criteria: The investigator judges that the patient has serious diseases that are not suitable for inclusion in this study, including but not limited to the following diseases: Complicated with respiratory diseases that may affect the efficacy and safety evaluation of the experimental drugs (such as clinically significant: asthma, pneumonia, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, cystic fibrosis, bronchiolitis obliterans, etc.); Complicated with a history of severe cardiovascular disease (such as: coronary artery insufficiency), clinically significant arrhythmia (such as high-grade atrioventricular block, atrial flutter/atrial fibrillation, supraventricular/ventricular tachycardia, etc.), hypertension, heart failure that cannot be effectively controlled, myocardial infarction occurred in the first 6 months before enrollment, or the results of the electrocardiogram have been judged by the investigator to have medical problems that may affect the safety of the patient; Complicated with other serious diseases or mental disorders (such as: stroke, epilepsy, uncontrolled hyperthyroidism, malignant tumors, etc.); Performed lobectomy, or performed lung volume reduction surgery within 12 months before screening; With multiple drug allergies; Alcoholism or drug abuse; Participated in other clinical studies within 3 months; End-stage COPD patients; Previously (within 6 months before the start of the study) or currently taking immune stimulating drugs at the same time (including thymosin, interferon, transfer factor, BCG polysaccharide, pneumonia vaccine and any kind of bacterial extracts, such as Biostim, except influenza vaccine) or immunization inhibitor During the acute exacerbation hospitalization, use intravenous hormone for more than 7 days and/or continuous hospitalization for more than 15 days; Have fertility and have not taken effective contraceptive measures (contraceptive methods include barrier contraception or hormonal contraception; barrier contraception includes: cervical cap, condom, intrauterine device, vaginal sponge, spermicide; hormonal contraception includes: contraceptive) ； According to the judgment of the investigator, the patient is not suitable for research observation.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ntaphylococcus albicans tablets<br>Participants received High-dose Staphylococcus albicans tablets (0.3 mg/tablet, 8 tablets each time, 3 times a day, Qilu Pharmaceutical Co., Ltd., course of treatment 90 days) or Normal-doseStaphylococcus albicans tablets (0.3 mg/tablet, 4 tablets each time, 3 times a day, Qilu Pharmaceutical Co., Ltd., course of treatment 90 days)+ placebo (4 tablets each time, 3 times a day, Qilu Pharmaceutical Co., Ltd., course of treatment 90 days). | Drug: High dose or normal dose staphylococcus albicans<br>* 8 staphylococcus albicans tablets(0.3 mg) 3 times daily or 4 staphylococcus albicans tablets(0.3 mg)+4 placebo tablets 3 times daily<br>|
| Placebo Comparator: Placebo<br>Participants received placebo (8 tablets each time, 3 times a day, Shandong Qilu Pharmaceutical Co., Ltd., course of treatment 90 days). | Drug: Placebo<br>* 8 placebo tablets 3 times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of acute exacerbations of chronic obstructive pulmonary disease in 1 year | The number of acute exacerbations of COPD in one year since the patients were enrolled in the group. | From enrollment to the end of the 1-year follow-up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Acute exacerbation, Bacterial lysates