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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staphylococcus and Neisseria group | Experimental | Experimental 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. |
|
| Standard care group | No Intervention | Standard care based on clinical experience without interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staphylococcus and Neisseria Tablets | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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).
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Change in frequency of AECOPD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongchang Sun, M.D. | Contact | 86-15611963697 | suny@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongchang Sun, M.D. | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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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).
| 12 months |
| 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. | 12 months |
| 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. | 1 month, 3 months, 6 months, and 12 months |
| 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. | 1 month, 3 months, 6 months, and 12 months |
| 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. | 1 month, 3 months, 6 months, and 12 months |
| 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. | 1 month, 3 months, 6 months, and 12 months |
| 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. | 1 month, 3 months, 6 months, and 12 months |
| 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. | 1 month, 3 months, 6 months, and 12 months |
| 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) | 6 months, and 12 months |
| 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. | 12 months |
| Adverse events | Occurrence of any Staphylococcus and Neisseria related adverse events during the study period. | 12 months |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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