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Status unknownNCT05543343Updated Sep 16, 2022

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

An interventional study of High dose or normal dose staphylococcus albicans and Placebo in Pulmonary Disease, Chronic Obstructive, sponsored by Qu Yiqing. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-16.

Sponsored by Qu Yiqing · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2022, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
495
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • COPD
  • Acute exacerbation
  • Bacterial lysates
03

In context

Pulmonary Disease, Chronic Obstructive

4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's planned enrollment of 495 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

This is the only study on the registry with Qu Yiqing as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
495 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugHigh 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

  • DrugPlacebo

    8 placebo tablets 3 times daily

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of the 1-year follow-up period

07

Study locations

1 of 1 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05543343
Lead sponsor
Qu Yiqing
Responsible party
Qu Yiqing (Professor, Qilu Hospital of Shandong University) — Sponsor-investigator
First posted
Sep 16, 2022
Start date
Jan 5, 2022
Primary completion
Mar 2023 (estimated)
Completion
Aug 2023 (estimated)
Last update
Sep 16, 2022

Study contacts

Yiqing Qu
Contact
quyiqing@sdu.edu.cn
+8618560082829
Yiqing Qu
study chair · Qilu Hospital of Shandong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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