Clinical trial NCT05543343: Staphylococcus and Neisseria Tablets in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease.
Official title: Evaluating the Efficacy and Safety of Staphylococcus and Neisseria Tablets in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Acute exacerbation
Bacterial lysates
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Qilu Pharmaceutical Co., Ltd.
First posted: 2022-09-16
Enrollment: 495
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age 40\~75 years old (including both ends), gender is not limited；
2. 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);
3. 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);
4. 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:

1. 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:

   1. 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.);
   2. 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;
   3. Complicated with other serious diseases or mental disorders (such as: stroke, epilepsy, uncontrolled hyperthyroidism, malignant tumors, etc.);
   4. Performed lobectomy, or performed lung volume reduction surgery within 12 months before screening;
   5. With multiple drug allergies;
   6. Alcoholism or drug abuse;
   7. Participated in other clinical studies within 3 months;
   8. End-stage COPD patients;
   9. 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
2. During the acute exacerbation hospitalization, use intravenous hormone for more than 7 days and/or continuous hospitalization for more than 15 days;
3. 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.

Primary outcomes:
measure: Number of acute exacerbations of chronic obstructive pulmonary disease in 1 year
timeFrame: From enrollment to the end of the 1-year follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yiqing Qu
role: STUDY_CHAIR
References: