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Chronic Obstructive Pulmonary DiseasePhase 4NCT05975788

Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease

A Phase 4 study testing Staphylococcus and Neisseria Tablets in people with Chronic Obstructive Pulmonary Disease, run by Peking University Third Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multi-center, prospective study. This study aims to investigate the incidence of acute exacerbation within 12 months, as well as the safety of Staphylococcus and Neisseria Tablets on patients with chronic obstructive pulmonary disease (COPD). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Staphylococcus and Neisseria Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
750 participants
Where
1 siteChina
Study dates
Nov 2023to Jul 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-80 years, males and females.
  • Clinical diagnosis of COPD, defined as FEV1/FVC<70% after inhaling bronchodilators.
  • At least 1 moderate to severe acute exacerbation of COPD in the past year.
  • Patient or their legal agent sign informed consent with a date after understanding the purpose and procedures of the research, and be willing to participate in the study.

Who cannot join

  • Patients with active pulmonary tuberculosis, asthma, or uncontrolled advanced malignant tumors; or after partial, lobar, or total pneumonectomy.
  • Patients with acute cardio cerebral vascular disease such as acute myocardial infarction, acute stroke and acute heart failure.
  • Patients with liver failure or renal failure and need blood purification treatment.
  • Patients with rheumatic diseases and autoimmune diseases.
  • Have participated or currently in interventional clinical trials within 30 days.
  • Patients with previous (within 3 months before signing the informed consent) or current use of immunomodulatory drugs (including thymosin, thymosin, interferon, transfer factor, BCG vaccine polysaccharide, and any kind of bacterial extract such as Biostim, pneumonia vaccine, and influenza vaccine).
  • Currently pregnant or breast-feeding women, or those who have fertility but cannot take contraceptive measures during the study period.
  • Other conditions that are not suitable for the trials according to investigator's judgement.

Trial locations and contacts

1 site in 1 country.

Yongchang Sun, M.D. contact

86-15611963697

suny@bjmu.edu.cn

China1 site

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease: A Multi-center, Prospective Study

This is a multi-center, prospective study. This study aims to investigate the incidence of acute exacerbation within 12 months, as well as the safety of Staphylococcus and Neisseria Tablets on patients with chronic obstructive pulmonary disease (COPD). In addition, this study investigates the improvement of hospitalization, improvement of pulmonary function, improvement of symptoms, and the use of anti-Infective drugs among COPD patients.

Read the detailed description

A total of 750 eligible COPD patients were enrolled, and were randomly divided into experimental group and control group with a ratio of 2:1. Experimental group will receive Staphylococcus and Neisseria Tablets (0.3mg/tablet) and standard care. Drug administration is 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months. Control group will receive standard care without interventions.

All participants have to sign informed consent. After baseline (V0/V1), participants will be followed up for 12 months with four follow-up visits at 4 weeks ± 14d (V2), 13 weeks ± 14d (V3), 26 weeks ± 14d (V4), and 52 weeks ± 14d (V5). Among them, V2 can be phone interview.

Being tested
Staphylococcus and Neisseria Tablets
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Staphylococcus and Neisseria TabletsDrug

    Staphylococcus and Neisseria tablets is used as an adjuvant treatment drug for respiratory disease in acute attack period, such as chronic tracheitis, bronchitis and various types of colds. It has been proved to effectively shorten the course of disease. In this study, Staphylococcus and Neisseria tablets will be administered with 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months according to clinicians.

Study groups in NCT05975788
Study groupRoleWhat they receive
Staphylococcus and Neisseria groupExperimentalExperimental group will receive Staphylococcus and Neisseria Tablets (0.3mg/tablet) and standard care. Administration Staphylococcus and Neisseria is 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months.
Receives: Drug: Staphylococcus and Neisseria Tablets
Standard care groupNo interventionStandard care based on clinical experience without interventions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AECOPD (Acute exacerbation COPD)

    Incidence of AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).

    • Mild：No respiratory failure. Respiratory rate 20-30 times/min; no use of ventilator or change in mental state; fraction of inspiration O2 (FiO2) improves after supplemental oxygen; no increase in partial pressure of CO2 in artery (PaCO2).
    • Moderate：Acute respiratory failure but not life threatening. Respiratory rate > 30 times/min; use of ventilator or change in mental state; FiO2>35% after supplemental oxygen, improved hypoxemia; hypercapnia, PaCO2 increases from baseline or increases to 50-60mmHg.
    • Severe：Acute respiratory failure and life threatening. Respiratory rate > 30 times/min; use of ventilator; acute changes in mental state; FiO2>45% after supplemental oxygen, no improvement in hypoxemia; PaCO2 increases by > 60mmHg from baseline or acidosis.

    Measured: 12 months

Secondary outcomes (12)

  1. Moderate or severe AECOPD

    Incidence of moderate or severe AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).

    Measured: 12 months

  2. Change in frequency of AECOPD

    Change in frequency of AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version).

    Measured: 12 months

  3. Hospitalization due to severe AECOPD

    Hospitalization due to severe AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version). Hospitalization include ICU admission.

    Measured: 12 months

  4. mMRC（modified Medical Research Council）

    Changes in mMRC during the observation period. mMRC score a 5-point (0-4) scale, and higher grades indicate higher severity of dyspnea.

    Measured: 1 month, 3 months, 6 months, and 12 months

  5. CAT（COPD Assessment Test）

    Changes in CAT during the observation period. CAT score ranges from 0 to 40 points, and higher scores indicate higher symptom burden of COPD on patients.

    Measured: 1 month, 3 months, 6 months, and 12 months

  6. TDI（Transition Dyspnea Index）

    Changes in TDI during the observation period. TDI score ranges from -9 to 9 points, and higher scores indicate more significant improvements from baseline.

    Measured: 1 month, 3 months, 6 months, and 12 months

  7. CET（Cough Evaluation Test）

    Changes in CET during the observation period. CET score ranges from 5 to 25 points, and higher scores indicate higher cough severity.

    Measured: 1 month, 3 months, 6 months, and 12 months

  8. Cough severity VAS（Visual Analog Scale）

    Changes in VAS during the observation period. VAS a 100-mm linear scale ranging from "no cough" (0 mm) to "worst cough" (100 mm), and higher scores indicate higher cough severity.

    Measured: 1 month, 3 months, 6 months, and 12 months

  9. Changes in the use of inhaled drugs

    According to the medication administration record, any changes in the use of inhaled drugs during the observation period, including dosage, frequency, duration, etc.

    Measured: 1 month, 3 months, 6 months, and 12 months

  10. Pulmonary function

    Changes in pulmonary function during the observation period. Pulmonary function is evaluated by the ratio of forced expiratory volume in the first second (FEV1) to forced vital capacity (FVC) (FEV1/FVC)

    Measured: 6 months, and 12 months

  11. Changes in the use of anti-infective drugs

    According to the medication administration record, any changes in the use of ianti-infective drugs within 12 months, including dosage, frequency, duration, etc.

    Measured: 12 months

  12. Adverse events

    Occurrence of any Staphylococcus and Neisseria related adverse events during the study period.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2023
  2. Study startNov 2023 (estimated)
  3. Primary completionFeb 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05975788
Sponsor's protocol ID
YL20230221
Status last verified
Nov 2023
First submitted
17 Jul 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Staphylococcus and Neisseria Tablets in people with Chronic Obstructive Pulmonary Disease, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongchang Sun, M.D. (86-15611963697, suny@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AECOPD (Acute exacerbation COPD) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05975788.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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