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Chronic Obstructive Pulmonary Disease (COPD)NCT07665359

Study on the Impact of Decolonization Treatment of Pneumocystis Jirovecii on the Frequency of Acute Exacerbation in COPD

A study testing Trimethoprim-Sulfamethoxazole (TMP-SMX) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 20 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Trimethoprim-Sulfamethoxazole (TMP-SMX)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
630 participants
Where
20 sitesChina
Study dates
1 Jul 2026to 1 May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
  • Informed consent

Who cannot join

  • 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;
  • Having a definite immunodeficiency disorder or receiving immunosuppressive therapy (such as HIV, agranulocytosis, solid organ or hematopoietic stem cell transplantation, malignant tumors, using long-term high-dose hormones > 20mg/day prednisone equivalent for more than 4 weeks)；
  • Severe liver and kidney dysfunction (ALT/AST > 3 times the upper limit of normal value, eGFR < 60 mL/min/1.73m²)；
Show all 10Show fewer
  • Pregnant, lactating women or those planning to become pregnant;
  • Folic acid deficiency-induced microcytic anemia;
  • Currently using coumarin, phenytoin, pioglitazone, repaglinide, rosiglitazone, glipizide or glibenclamide;
  • Currently participating in other interventional clinical studies；

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hua Zhou, Doctor contact

+86 571 8723 6876

zhouhua1@zju.edu.cn

20 sites in 1 country

China20 sites

  • West China Hospital

    Chengdu, Sichuan

    Chengdi Wang

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Zhengtu Li

  • First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang

    Yinan Yao, yaoyinan@zju.edu.cn

  • Red Cross Hospital, Hangzhou, China

    Hangzhou, Zhejiang

    Chuhui Ru

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang

    Hequan Li

  • Zhejiang Hospital

    Hangzhou, Zhejiang

    Jian Ye

  • Huzhou Central Hospital

    Huzhou, Zhejiang

    Bin Wang

  • Affiliated Hospital of Jiaxing University

    Jiaxing, Zhejiang

    Wenyu Chen

  • Zhejiang Rongjun Hospital

    Jiaxing, Zhejiang

    Lixin Wu

  • Lishui hospital of Zhejiang University

    Lishui, Zhejiang

    Youyi Du

  • The Sixth Affiliated Hospital of Wenzhou Medical University

    Lishui, Zhejiang

    Jinwei Huang

  • Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Xinyi Zhang

  • Zhejiang Quhua Hospital

    Quzhou, Zhejiang

    Kai Fang

  • Shanghai Pulmonary Hospital, Shanghai, China

    Shanghai, Shanghai Municipality

    Shuyi Gu

  • Shanghai Tongji Hospital, Tongji University School of Medicine

    Shanghai, Shanghai Municipality

    Yingzhou Xie

  • Shaoxing People's Hospital

    Shaoxing, Zhejiang

    Xing Chen

  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

    Taizhou, Zhejiang

    Xiaomai Wu

  • Taizhou Hospital

    Taizhou, Zhejiang

    Junfei Zhu

  • First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Yuping Li

  • Tongji Hospital

    Wuhan, Hubei

    Yuanzhou He

Other trials in China

About this study

Official title: A Multicenter, Prospective, Double-blind, Randomized Controlled Study on the Impact of Decolonization Treatment on the Frequency of Acute Exacerbation in Patients With Chronic Obstructive Pulmonary Disease Colonized With Pneumocystis Jirovecii

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:

Read more
  • 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
Being tested
Trimethoprim-Sulfamethoxazole (TMP-SMX), Placebo
Keywords
Chronic Obstructive Pulmonary Disease, Pneumocystis jirovecii, Trimethoprim-Sulfamethoxazole
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trimethoprim-Sulfamethoxazole (TMP-SMX)Drug

    Also called Bactrim, Sulfatrim

    Receipt of tablet with the equivalent of one double-strength (DS) TMP-SMX（TMP 160mg + SMZ 800mg） per day by mouth for 4 weeks

  • PlaceboDrug

    Receipt of tablet with placebo by mouth every day for 4 weeks

Study groups in NCT07665359
Study groupRoleWhat they receive
TMP-SMXExperimentalTablet with the equivalent of one DS TMP-SMX per day by mouth for 4 weeks
Receives: Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)
placeboPlacebo comparatorTablet with placebo by mouth every day for 4 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD) over one year

    Measured: Baseline (Day 1) to 12 months

Secondary outcomes (8)

  1. The clearance rate of TMP-SMX in eliminating Pneumocystis jirovecii in the lower respiratory tract

    Measured: 1month

  2. The duration of clearance of Pneumocystis jirovecii in the lower respiratory tract

    Measured: 3 months，12 months

  3. 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.

    Measured: 1month，3 months，6 months and 12 months

  4. 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.

    Measured: 1month，3 months，6 months and 12 months

  5. All-cause mortality rate

    Measured: Baseline to 12 months

  6. 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.

    Measured: Baseline to 1month and 12 months

  7. Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    Measured: Baseline to 3 months，6 months and 12 months

  8. Incidence rate of adverse events

    Measured: 2 weeks and 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion1 May 2029 (estimated)
  4. Study completion1 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
630 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07665359
Sponsor's protocol ID
2026-0378
Status last verified
May 2026
First submitted
15 Jun 2026
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Trimethoprim-Sulfamethoxazole (TMP-SMX) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 20 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hua Zhou, Doctor (+86 571 8723 6876, zhouhua1@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07665359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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