Clinical trial NCT05975788: Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease
Official title: Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease: A Multi-center, Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: AECOPD (Acute exacerbation COPD)
timeFrame: 12 months
Secondary outcomes:
measure: Moderate or severe AECOPD
timeFrame: 12 months
measure: Change in frequency of AECOPD
timeFrame: 12 months
measure: Hospitalization due to severe AECOPD
timeFrame: 12 months
measure: mMRC（modified Medical Research Council）
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: CAT（COPD Assessment Test）
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: TDI（Transition Dyspnea Index）
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: CET（Cough Evaluation Test）
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: Cough severity VAS（Visual Analog Scale）
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: Changes in the use of inhaled drugs
timeFrame: 1 month, 3 months, 6 months, and 12 months
measure: Pulmonary function
timeFrame: 6 months, and 12 months
measure: Changes in the use of anti-infective drugs
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yongchang Sun, M.D.
role: PRINCIPAL_INVESTIGATOR
References: