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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: High dose or normal dose staphylococcus albicans; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 495
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yiqing Qu; Phone Number: +8618560082829; Email: quyiqing@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Yiqing Qu; Phone Number: +8618560082829; Email: quyiqing@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ntaphylococcus albicans tablets; 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; 8 staphylococcus albicans tablets(0.3 mg) 3 times daily or 4 staphylococcus albicans tablets(0.3 mg)+4 placebo tablets 3 times daily
PLACEBO_COMPARATOR: Placebo; Participants received placebo (8 tablets each time, 3 times a day, Shandong Qilu Pharmaceutical Co., Ltd., course of treatment 90 days).	Drug: Placebo; 8 placebo tablets 3 times daily

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qu Yiqing
• Collaborators: Qilu Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Yiqing Qu, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2022
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (ACTUAL): September 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: COPD; Acute exacerbation; Bacterial lysates
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: quyiqing@sdu.edu.cn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No