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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
630
Receipt of tablet with the equivalent of one double-strength (DS) TMP-SMX(TMP 160mg + SMZ 800mg) per day by mouth for 4 weeks
Receipt of tablet with placebo by mouth every day for 4 weeks
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Tongji Hospital
Wuhan, Hubei, China
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai, Shanghai Municipality, China
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital
Chengdu, Sichuan, China
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Red Cross Hospital, Hangzhou, China
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
...and 10 more locations
Annualized rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD) over one year
Time frame: Baseline (Day 1) to 12 months
The clearance rate of TMP-SMX in eliminating Pneumocystis jirovecii in the lower respiratory tract
Time frame: 1month
The duration of clearance of Pneumocystis jirovecii in the lower respiratory tract
Time frame: 3 months,12 months
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.
Time frame: 1month,3 months,6 months and 12 months
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.
Time frame: 1month,3 months,6 months and 12 months
All-cause mortality rate
Time frame: Baseline to 12 months
Airway microbiota analysis
The microbiome of qualified sputum will be measurable by metagenomic next-generation sequencing (mNGS) technologies. Its characteristic parameters include the alpha diversity and beta diversity of the microbiome.
Time frame: Baseline to 1month and 12 months
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline to 3 months,6 months and 12 months
Incidence rate of adverse events
Time frame: 2 weeks and 1 month
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