Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Experimental Group:The TMP-SMX decolonization regimen is as follows: 2 tablets (each tablet contains SMZ 400 mg + TMP 80 mg), taken orally once daily for 4 consecutive weeks.
Control Group:Placebo, 2 tablets, taken orally once daily for 4 consecutive weeks.
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 40 and above,male or female; 2. Patients with chronic obstructive pulmonary disease (COPD) who meet the diagnostic criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2026 ( post-bronchodilator FEV1/FVC = 30%), and are in the high-risk group for acute exacerbation (Group E, >= 1 moderate or severe acute exacerbation within 12 months before screening);B 3. ackground triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for >=1 month prior to the first visit; Double therapy (LABA + LAMA) allowed if ICS is contraindicated; 4. PCR detection of Pneumocystis jirovecii in induced sputum is positive; 5. The patient voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergic to TMP, SMX or sulfonamide drugs; 2. There are pneumonia or other infections that require long-term use of antibacterial drugs (such as tuberculosis, NTM, other fungi, etc.); 3. Having used antibiotics within the previous 4 weeks before screening; 4. Having a definite immunodeficiency disorder or undergoing immunosuppressive therapy (such as HIV, agranulocytosis, solid organ or hematopoietic stem cell transplantation, malignant tumors, long-term high-dose hormones > 20mg/day prednisone equivalent for more than 4 weeks); 5. Severe liver and kidney dysfunction (ALT/AST > 3 times the upper limit of normal value, eGFR < 60 mL/min/1.73m²); 6. Pregnant, lactating women or those planning to become pregnant; 7. Folic acid deficiency-induced microcytic anemia; 8. Currently using coumarin, phenytoin, pioglitazone, repaglinide, rosiglitazone, glipizide or glibenclamide; 9. Currently participating in other interventional clinical studies; 10. The researchers determined that there were other circumstances that made it unsuitable for individuals to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The annualized incidence rate of moderate to severe acute exacerbations in patients with COPD who had Pneumocystis colonization and had a high risk of acute exacerbation within one year; | — |
Secondary
| Measure | Time frame |
|---|---|
| TMP-SMX clearance and duration of maintenance for Pneumocystis jirovecii in the lower respiratory tract;Changes in symptom scores (CAT scores, mMRC scores) compared to the baseline level;All-cause mortality rate;Airway microbiota analysis;The changes in pulmonary function (FEV1% predicted value) of the two groups of patients compared to the baseline level;Incidence rate of adverse events; | — |
Countries
China
Contacts
Public ContactHua Zhou
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed