Stable chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Placebo group:Routine basic treatment for chronic obstructive pulmonary disease (COPD)
Experimental group:Routine basic treatment for chronic obstructive pulmonary disease (COPD)
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. COPD was diagnosed for >=12 months at the time of screening (meeting the diagnostic criteria of the GOLD guidelines); 2. During the screening period, the forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) measured after the use of bronchodilators was less than 0.70, and the percentage of FEV1 to the predicted value after the use of bronchodilators was greater than or equal to 30% and less than 80%. 3. Age between 40 and 80 years old (including the boundary value), gender not limited; 4) There were >=2 records of moderate or >=1 record of severe acute exacerbation of COPD within 12 months prior to screening [previously received standard inhalation therapy] Such as triple inhalation therapy (ICS+LABA+LAMA) or ICS+LABA dual therapy, or for patients who are not suitable for ICS but are still at high risk of developing the disease after using LABA+LAMA dual therapy. High risk of disease is defined as a patient meeting one or more of the following criteria: having experienced >=2 moderate or >=1 severe exacerbation of the condition in the past year (defined as requiring systemic corticosteroids and/or antibiotics for at least 3 days or being hospitalized due to AECOPD within 1 year prior to screening). Frequent coughing with phlegm is defined as an affirmative answer to both of the following two questions: First, in the past three months, I have been coughing at least a few days a week; Secondly, in the past three months, I have coughed up phlegm for at least a few days a week. Forced expiratory volume in the first second after bronchiectasis is less than 50% of the predicted value. 5. No moderate or severe acute exacerbation of COPD occurred within 8 weeks before randomization or from the screening period to day 1. 6. Current smokers or those who have quit smoking with a history of 10 packs per year (" pack year "refers to the average daily smoking quantity multiplied by the number of years of smoking divided by 20, for example, 1 pack year equals smoking 20 cigarettes per day for 1 year, or smoking 10 cigarettes per day for 2 years); 7. Those who received background treatment for COPD for more than or equal to 3 months before randomization and had stable treatment doses one month before screening and during the screening period (defined as those who had been treated according to stable triple therapy or dual therapy and other standard treatments for more than or equal to 3 months before enrollment, where stable dose requirements met 80% of the regular treatment or were determined by the investigator to meet the regular treatment requirements); 8. Be willing to join and sign the written informed consent form;
Exclusion criteria
Exclusion criteria: 1.Presence of other clinically significant respiratory diseases (excluding COPD) at screening that, in the investigator’s judgment, may affect the study’s outcome measures, including but not limited to: a-1 antitrypsin deficiency, active pulmonary tuberculosis, bronchiectasis, sarcoidosis, pulmonary arterial hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans, or other active pulmonary diseases; 2.A history of bronchial asthma or current diagnosis of asthma (as per diagnostic criteria); 3.Comorbidity with other severe and/or uncontrolled major organ diseases or unstable systemic diseases, including but not limited to: uncontrolled diabetes mellitus, unstable angina pectoris, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), severe congestive heart failure (NYHA >= Class 3), uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg, regardless of antihypertensive treatment), uncontrolled active infections, severe hepatic/renal diseases (ALT or AST > 1.5 × upper limit of normal [ULN] and/or Cr > 1.5 × ULN), other severe metabolic diseases, severe gastrointestinal diseases, or any psychiatric disorders that impair the ability to comply with study procedures; 4.Presence of upper or lower respiratory tract infections within 4 weeks prior to screening or during the screening period; 5.A history of malignant tumors within the past 5 years; 6.Use of or need for long-term use of any non-invasive positive pressure ventilation (NIPPV) devices; 7.Pregnant or lactating women, women planning to become pregnant, or those unable to use effective contraceptive measures; 8.A history of hypersensitivity to the investigational product, background medications, or their excipients; 9.At screening, assessment indicating the need for systemic corticosteroid treatment; or current use of azithromycin maintenance therapy for more than 4 weeks with no plan to discontinue; or use of drugs affecting immune function within 7 days prior to randomization (immunosuppressants: systemic glucocorticoids, calcineurin inhibitors, etc.; immunostimulants: bacillus Calmette-Guérin [BCG], levamisole, thymosin, etc.; other immunotherapies: methotrexate, cyclosporine, tacrolimus, etc.; immunoglobulins or blood products; live vaccines, attenuated vaccines, or mRNA vaccines, etc.); 10.Presence of active autoimmune diseases or receipt of immunosuppressive therapy (e.g., patients with rheumatoid arthritis, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis); Positive human immunodeficiency virus antibody (HIV-Ab), active hepatitis B, or positive Treponema pallidum antibody; 11.Positive human immunodeficiency virus antibody (HIV-Ab), active hepatitis B, or positive Treponema pallidum antibody; 12.A history of pneumonectomy (excluding lobectomy or segmentectomy), or lung volume reduction surgery within 12 months prior to screening, or planned lung volume reduction surgery during the study period; 13.Receipt of live attenuated vaccine within 4 weeks prior to screening or during the screening period; 14.Receipt of any other investigational drug or participation in another interventional clinical trial within 3 months prior to screening; 15.Inability to comply with the study protocol or other circumstances deemed inappropriate for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized incidence rate of moderate to severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) during the 52-week treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in the scores of the Self-Assessment Test (CAT), the modified Medical Research Council Respiratory Questionnaire (mMRC), and the St. George Respiratory Questionnaire (SGRQ) during the 52-week treatment period compared to the baseline;Changes in immune indicators during the 52-week treatment period;The changes in pulmonary function (FEV1, FVC) before and after the use of bronchodilators during the 52-week treatment period compared with the baseline;The annualized incidence of CID during the 52-week treatment period;The time from the start of treatment to the occurrence of the first clinically significant deterioration indicator;The time from the start of treatment to the occurrence of the first moderate or severe AECOPD;The length of hospital stay for moderate or severe AECOPD during the 52-week treatment period; | — |
Countries
China
Contacts
Public ContactYongchang Sun
Peking University Third Hospital
Outcome results
None listed