Lung FibrosisNCT07236541
Impact of Airway Mucus Plugs on Secondary Pulmonary Fibrosis in COPD Patients: A Single-Center Case-Control Study
An observational study of Lung Fibrosis, run by Ming Zhong at 1 site in China.
Trial summary
Chronic obstructive pulmonary disease (COPD) is frequently accompanied by airway mucus plugs, which are closely associated with airflow obstruction, acute exacerbations, and increased mortality. However, whether mucus plugs contribute to secondary pulmonary fibrosis remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Lung Fibrosis
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2025to 30 Jun 2026
- Phase
- Observational
- 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 18 to 89 years
- All sexes
- Adult, Older adult
Study population: The study population consists of adult patients undergoing lung cancer surgery at Zhongshan Hospital, Fudan University. Participants include two groups: (1) patients with chronic obstructive pulmonary disease (COPD), defined by a pre-operative post-bronchodilator FEV₁/FVC <0.70; and (2) non-COPD surgical controls with normal lung function. During clinically indicated lung cancer resection, distal non-tumorous lung tissue samples and airway mucus (if present) are collected without adding any additional surgical risk. All participants are ≥18 years old and able to provide informed consent.
Who may be able to join
- ① Age ≥ 18 years old;
- Planned radical resection for lung cancer, with postoperative pathological diagnosis of primary lung cancer;
- During surgery, non tumor lung tissue at a distance of ≥ 5 cm from the tumor edge can be obtained; ④ Case group: Preoperative pulmonary function examination confirmed diagnosis of COPD (FEV ₁/FVC<0.70); ⑤ Control group: Preoperative lung function was normal (FEV ₁/FVC ≥ 0.70), with no history of COPD; ⑥ The subjects are able to understand and sign the informed consent form
Who cannot join
- ① Clear presence of other interstitial lung diseases (ILD) or idiopathic pulmonary fibrosis before or during surgery （IPF）、 Fibrosis after pneumoconiosis or tuberculosis;
- Active pulmonary infections (such as bacterial pneumonia, fungal infections, active tuberculosis);
- Having received neoadjuvant radiotherapy or chemotherapy, which may affect the morphology or molecular results of distal lung tissue; ④ Combined severe immunodeficiency or long-term systemic immunosuppressive therapy (such as glucocorticoids ≥ 20 mg/d, More than 4 weeks);
- Merge with other serious systemic diseases (such as advanced heart failure, end-stage renal disease), affecting study compliance or Survival expectation; ⑥ Pregnant or lactating women; ⑦ Refusing to sign the informed consent form or deemed unsuitable by the researcher to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital
Shanghai, 200433
shengyu hao, 18359181031, janet9yu@163.com
About this study
Chronic obstructive pulmonary disease (COPD) is frequently accompanied by airway mucus plugs, which are closely associated with airflow obstruction, acute exacerbations, and increased mortality. However, whether mucus plugs contribute to secondary pulmonary fibrosis remains unclear. This single-center, prospective, case-control study aims to investigate the relationship between airway mucus plugs and lung fibrosis in patients with COPD undergoing lung cancer surgery.
During surgery, distal non-tumorous lung tissues and airway mucus will be collected for histological and molecular analyses. Mucus plug burden will be quantified using AB-PAS staining, and fibrosis will be assessed using Masson staining. Expression of epithelial-mesenchymal transition (EMT) markers, fibrotic markers, and the mechanosensitive ion channel Piezo1 will also be measured. COPD patients (FEV₁/FVC <0.70) will be compared with non-COPD surgical controls.
The study aims to clarify whether mucus plugs are associated with increased fibrosis and to explore the potential involvement of mechanical-signaling pathways, including Piezo1 activation. Findings may provide new clinical and pathological evidence for mucus-induced fibrotic remodeling in COPD and help identify novel therapeutic targets.
- Conditions
- Lung Fibrosis
- Being tested
- No intervention; observational biospecimen collection only
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; observational biospecimen collection onlyOther
No intervention; observational biospecimen collection only
| Study group | Role | What they receive |
|---|---|---|
| COPD（chronic hypoxia） | Not described Receives: Other: No intervention; observational biospecimen collection only | |
| Normal（Normoxia） | Not described Receives: Other: No intervention; observational biospecimen collection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clarify the relationship between airway mucus embolism and secondary pulmonary fibrosis in COPD patients
By comparing the distal lung tissue of patients undergoing COPD and non COPD lung cancer surgery, a systematic evaluation was conducted to determine the difference between airway mucus thrombus load and the degree of lung tissue fibrosis, and to answer whether airway mucus thrombus is an important pathological factor promoting secondary pulmonary fibrosis in COPD.
Measured: At the time of surgery and within 6 months after sample collection for laboratory analysis
Secondary outcomes (1)
The correlation between mucus plugs and clinical features
Explore the relationship between mucus clot burden and clinical characteristics (such as smoking history, lung function, hypoxic status) and pathological indicators of patients.
The association between mucus plugs and fibrosis molecular markers:
Detect and compare epithelial mesenchymal transition (EMT) related molecules (E-cadherin, Vimentin), fibrosis markers (α - SMA, COL1A1), inflammatory markers, etc., to clarify the association between mucosal thrombus load and molecular level fibrosis response.
Possible functions of Piezo1 channel:
Preliminary exploration of the correlation between mucus clot load and Piezo1 expression and activity, providing clinical pathological evidence for revealing the role of mechanical pathways in mucus induced fibrosis.
Measured: At the time of surgery and within 6 months after sample collection for laboratory analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start30 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming Zhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming Zhong, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236541
- Sponsor's protocol ID
- B2025-657
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Airway Mucus Plugs on Secondary Pulmonary Fibrosis in COPD Patients: A Single-Center Case-Control Study
- ClinicalTrials.gov ID
- NCT07236541
- Acronym / sponsor ID
- B2025-657
- Conditions
- Lung Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ming ZhongUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic obstructive pulmonary disease (COPD) is frequently accompanied by airway mucus plugs, which are closely associated with airflow obstruction, acute exacerbations, and increased mortality. However, whether mucus plugs contribute to secondary pulmonary fibrosis remains unclear. This single-center, prospective, case-control study aims to investigate the relationship between airway mucus plugs and lung fibrosis in patients with COPD undergoing lung cancer surgery.
During surgery, distal non-tumorous lung tissues and airway mucus will be collected for histological and molecular analyses. Mucus plug burden will be quantified using AB-PAS staining, and fibrosis will be assessed using Masson staining. Expression of epithelial-mesenchymal transition (EMT) markers, fibrotic markers, and the mechanosensitive ion channel Piezo1 will also be measured. COPD patients (FEV₁/FVC <0.70) will be compared with non-COPD surgical controls.
The study aims to clarify whether mucus plugs are associated with increased fibrosis and to explore the potential involvement of mechanical-signaling pathways, including Piezo1 activation. Findings may provide new clinical and pathological evidence for mucus-induced fibrotic remodeling in COPD and help identify novel therapeutic targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD（chronic hypoxia） | – | Other: No intervention; observational biospecimen collection only |
| Normal（Normoxia） | – | Other: No intervention; observational biospecimen collection only |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients undergoing lung cancer surgery at Zhongshan Hospital, Fudan University. Participants include two groups: (1) patients with chronic obstructive pulmonary disease (COPD), defined by a pre-operative post-bronchodilator FEV₁/FVC <0.70; and (2) non-COPD surgical controls with normal lung function. During clinically indicated lung cancer resection, distal non-tumorous lung tissue samples and airway mucus (if present) are collected without adding any additional surgical risk. All participants are ≥18 years old and able to provide informed consent.
Key inclusion criteria (3 listed)
- ① Age ≥ 18 years old;
Key exclusion criteria (4 listed)
- ① Clear presence of other interstitial lung diseases (ILD) or idiopathic pulmonary fibrosis before or during surgery （IPF）、 Fibrosis after pneumoconiosis or tuberculosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention; observational biospecimen collection onlyNo intervention; observational biospecimen collection only | Other | COPD（chronic hypoxia）, Normal（Normoxia） |
Primary outcome
Clarify the relationship between airway mucus embolism and secondary pulmonary fibrosis in COPD patients
Time frame: At the time of surgery and within 6 months after sample collection for laboratory analysis
By comparing the distal lung tissue of patients undergoing COPD and non COPD lung cancer surgery, a systematic evaluation was conducted to determine the difference between airway mucus thrombus load and the degree of lung tissue fibrosis, and to answer whether airway mucus thrombus is an important pathological factor promoting secondary pulmonary fibrosis in COPD.
1 secondary outcome
The correlation between mucus plugs and clinical features
Time frame: At the time of surgery and within 6 months after sample collection for laboratory analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Fibrosis, run by Ming Zhong at 1 site 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 shengyu hao (18359181031, janet9yu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clarify the relationship between airway mucus embolism and secondary pulmonary fibrosis in COPD patients (time frame: At the time of surgery and within 6 months after sample collection for laboratory analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025.