Previous researches have found the common colonization of Pneumocystis jirovecii (Pj) in the airways of people with chronic obstructive pulmonary disease (COPD). And this colonization may exacerbate airway inflammation and increase the frequency of acute exacerbation in people with COPD.
The goal of this clinical trial is to study if "decolonization treatment" (that is, removing these colonizing Pj) works to improve the prognosis of COPD colonized by Pj in adults. The main question it aims to answer is:
* Does the Trimethoprim-Sulfamethoxazole (TMP-SMX, an antibiotics) decolonization treatment reduce the frequency of acute exacerbation in participants with COPD colonized by Pj who have a high risk of acute exacerbation.
Researchers will compare TMP-SMX to a placebo (a look-alike substance that contains no drug) to see if TMP-SMX works to reduce the frequency of acute exacerbation of COPD.
Participants will:
* Take drug TMP-SMX or a placebo 2 tablet every day for 4 weeks. * Visit the clinic after 2 weeks, 1 month, 3 months, 6 months and 12 months for survey questions, checkups and tests. * Keep a diary of their symptoms and the number of times they experience acute exacerbations
Age 40 and above，male or female；
COPD who meet the diagnostic criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2026 ( post-bronchodilator FEV1/forced vital capacity [FVC] ratio < 0.7 and post-bronchodilator FEV1% predicted ≥ 30%), and have documented history of high exacerbation risk (Group E, defined as exacerbation history of ≥ 1 moderate or severe acute exacerbation within 12 months prior to inclusion)；
Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to inclusion; Double therapy (LABA + LAMA) allowed if ICS is contraindicated；
PCR detection of Pneumocystis jirovecii in induced sputum is positive；
Allergic to TMP, SMX or sulfonamide drugs；
There are pneumonia or other infections that require long-term use of antibacterial drugs (such as tuberculosis, NTM, other fungi, etc.)；
Having used antibiotics within the previous 4 weeks prior to screening；
Experience of AECOPD events within the previous 4 weeks prior to screening;
Parallel
Trimethoprim-Sulfamethoxazole (TMP-SMX)
DrugReceipt of tablet with the equivalent of one double-strength (DS) TMP-SMX（TMP 160mg + SMZ 800mg） per day by mouth for 4 weeks
Placebo
DrugReceipt of tablet with placebo by mouth every day for 4 weeks
Annualized rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD) over one year
The clearance rate of TMP-SMX in eliminating Pneumocystis jirovecii in the lower respiratory tract
The duration of clearance of Pneumocystis jirovecii in the lower respiratory tract
Change from baseline in COPD Assessment Test (CAT) total score
The test has a score of 0 (minimum) - 40 (maximum); a lower score means a better outcomes and a higher score means a worse outcome.Negative numbers indicate improvement of condition. Positive numbers indicate worsening of condition.
Change from baseline in modified Medical Research Council dyspnea scale (mMRC)
The mMRC scale consists of 5 grades (0-4), based on how much breathlessness limits physical activity. Higher mMRC scores mean a worse outcome.
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborator
Zhejiang Rongjun Hospital
Collaborator
Zhejiang Quhua Hospital
Collaborator
West China Hospital
Collaborator
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborator
Huzhou Central Hospital
Collaborator
Shaoxing People's Hospital
Collaborator
Affiliated Hospital of Jiaxing University
Collaborator
Red Cross Hospital, Hangzhou, China
Collaborator
Taizhou Hospital
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Zhejiang Hospital
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Lishui hospital of Zhejiang University
Collaborator
Tongji Hospital
Collaborator
The Sixth Affiliated Hospital of Wenzhou Medical University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
