Interstitial Lung Diseases (ILD)EDCS-LIADNCT06987266
Establishment of Diagnosis and Classification System for Lung Interstitial and Airway Diseases (LIAD)
An observational study of Interstitial Lung Diseases (ILD) and Airway Disease, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study focuses on both hospitalized and outpatient populations. Through a multicenter, retrospective study, it aims to comprehensively characterize:The comorbidity of interstitial lung diseases (ILD) and airway diseases;The comorbidity of ILD with other intrapulmonary diseases;The comorbidity of airway diseases… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Interstitial Lung Diseases (ILD), Airway Disease
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 30 Nov 2028
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Among the inpatient or outpatient patients in 9 Grade A hospitals, at least 900 patients with COPD combined with/uncombined interstitial lung abnormalities, idiopathic pulmonary fibrosis combined with/uncombined airway disease, nonspecific interstitial pneumonia combined with/uncombined airway disease, pulmonary fibrosis combined with emphysema syndrome.
Who may be able to join
- age between 40-80 years old;
- inpatients with an admission diagnosis of COPD, Idiopathic pulmonary fibrosis, nonspecific interstitial pneumonia, patients with the following diagnoses were screened by chest CT (slice thickness ≤1.5 mm) during hospitalization and by in-hospital or prior pulmonary function;
- Inpatients who meet the criteria can complete pulmonary function tests and chest HRCT examinations within one month before expected discharge (excluding hospitalized patients with stable interstitial lung disease or airway disorders);
- among outpatients, patients with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, nonspecific interstitial pneumonia, COPD with pulmonary interstitial abnormalities, idiopathic pulmonary fibrosis with airway lesions, nonspecific interstitial pneumonia with airway lesions, pulmonary fibrosis with emphysema syndrome were diagnosed through chest CT (layer thickness ≤1.5mm) and lung function;
- provide informed consent.
Who cannot join
- expected survival less than 12 months;
- planned lung transplantation or pneumonectomy within 12 months;
- pregnant or lactating women;
- Has previously undergone lobectomy or received thoracic radiotherapy.
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
Xiangya Hospital
Changsha, Hunan, 410008
13974813903
urnotchengwei@163.com
About this study
This study focuses on both hospitalized and outpatient populations. Through a multicenter, retrospective study, it aims to comprehensively characterize:The comorbidity of interstitial lung diseases (ILD) and airway diseases;The comorbidity of ILD with other intrapulmonary diseases;The comorbidity of airway diseases with other intrapulmonary diseases;The comorbidity of ILD and airway diseases with extrapulmonary diseases.Based on these findings, the study seeks to propose classification and diagnostic criteria for ILD and airway disease comorbidities.Additionally, a multicenter, prospective, disease-specific cohort study will be conducted to observe the prognosis of patients with ILD and/or airway diseases, identify prognostic factors, and grade the severity of comorbid conditions based on these factors.Finally, the study will analyze the current state of interventions and the medical costs associated with ILD and airway disease comorbidities through a cost-effectiveness analysis, aiming to propose new strategies for integrated disease management.
Read the detailed description
This study is divided into two parts, the first part is a multi-center, retrospective study of 9 units in the past 36 months of medical records (10,000 cases) were analyzed; The second part is a multi-center, prospective, observational cohort study. A total of 900 patients with pulmonary interstitial and airway diseases were enrolled, including hospitalized patients, outpatients, and subjects to be confirmed for 2-year follow-up. The total study period was 4 years (2024 December to 2028 November) .
- A retrospective study was conducted in 9 tertiary hospitals across the country to collect data on cases discharged from respiratory and critical care medicine departments in the previous 36 months (2022 February to February 2025)(about 10,000 cases) , from which cases with a diagnosis of interstitial lung disease, airway disease were screened according to the discharge diagnosis ICD-10 code (disease classification and Code National Clinical Edition 2.0)(Table 1) , the clinical data, chest CT, lung function and intervention measures of the cases were collected to describe the comorbidity and intervention situation of hospitalized pulmonary interstitial and airway diseases in our country, and to put forward the classification and diagnostic criteria of pulmonary interstitial and airway diseases. By collecting data on patients with interstitial lung disease and airway disease who had been hospitalized in the respiratory and critical care unit in the previous 36 months at 9 tertiary hospitals, to describe the distribution of diseases, treatment and medical burden of pulmonary interstitial and airway diseases, pulmonary interstitial diseases, airway diseases and other intrapulmonary diseases, pulmonary interstitial diseases, airway diseases and extrapulmonary diseases in hospitalized patients, etc. , the classification and diagnostic criteria of pulmonary interstitial and airway diseases were proposed.
- A prospective cohort study of comorbidity pulmonary interstitial and airway diseases was conducted in 9 tertiary hospitals across the country. The cohort patients were from three sources, hospitalized in the department of respiratory and critical care medicine, and hospitalized in the department of respiratory and critical care medicine, or outpatient clinics and checkup centers. Part 1 and Part 2: Screening of COPD patients with and without interstitial lung disease, Idiopathic pulmonary fibrosis with and without airway disease, nonspecific interstitial pneumonia with and without airway disease, and pulmonary fibrosis with emphysema in the inpatient and outpatient departments of respiratory and critical care medicine. In the third part, patients with pulmonary interstitial and/or airway diseases requiring respiratory specialist diagnosis in the subject I physical examination population screening, and patients with pulmonary interstitial and/or airway diseases requiring treatment after specialist judgment, were included, the risk factors, clinical information and biological samples of the patients were collected and followed up for 2 years (once every 12 months) . The prognostic information of the patients was collected and the influencing factors related to the prognosis were identified. The severity of comorbidity pulmonary interstitial and airway diseases was graded by analyzing the prognostic factors. By analyzing the intervention status of pulmonary interstitial and airway comorbidity diseases and the cost-effectiveness of medical costs, a new strategy of co-management was proposed. At the same time, it provides data support for the research of the first, fourth, fifth and sixth topic, and provides biological sample support for the third topic.
Clinical data, healthcare resource use, and bio-specimens were collected at baseline and at 2-year follow-up (every 12 months) from 9 Grade III, Class A hospital of respiratory and critical care medicine inpatients, outpatients, and patients with specialty-diagnosed interstitial lung disease and airway disease in the subject 1 physical examination population, to conduct a multi-center, prospective cohort study of comorbidity pulmonary interstitial and airway diseases and identify the influencing factors related to the prognosis of patients with pulmonary interstitial and/or airway diseases. The severity of comorbidity pulmonary interstitial and airway diseases was graded by analyzing the prognostic factors. By analyzing the intervention status of pulmonary interstitial and airway comorbidity diseases and the cost-effectiveness of medical costs, a new strategy of co-management was proposed.
- Conditions
- Interstitial Lung Diseases (ILD), Airway Disease
- Being tested
- no intervention
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no ntervention
| Study group | Role | What they receive |
|---|---|---|
| COPD with ILA | Chronic obstructive pulmonary disease complicated with interstitial lung abnormalities: patients were treated routinely without additional intervention. Receives: Other: no intervention | |
| PF with emphysema syndrome | Pulmonary fibrosis with emphysema syndrome: patients were treated routinely without additional intervention. Receives: Other: no intervention | |
| NSIP | Nonspecific interstitial pneumonia: patients were treated routinely without additional intervention. Receives: Other: no intervention | |
| IPF | Idiopathic pulmonary fibrosis: patients were treated routinely without additional intervention. Receives: Other: no intervention | |
| COPD | Chronic obstructive pulmonary disease: patients were treated routinely without additional intervention. Receives: Other: no intervention | |
| NSIP with airway disease | Nonspecific interstitial pneumonia with airway disease: patients were treated routinely without additional intervention. Receives: Other: no intervention | |
| IPF with airway disease | Idiopathic pulmonary fibrosis with airway disease: patients were treated routinely without additional intervention. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acute exacerbation
Measured: 12 months，24 months
Annual rate/value of decline in lung function
The main indicators observed for the annual lung function decline rate include △FEV1/pred, △FVC/pred, △DLCO/pred, △FEF50%/pred, △FEF75%/pred, △MMEF/pred; the main indicators observed for the annual lung function decline value include △FEV1, △FVC, △DLCO
Measured: 12 months，24 months
Survival status
questionnaire
Measured: 12 months，24 months
Advances in chest imaging
Evaluation indicators of chest imaging advances include emphysema degree , airway wall thickness and Interstitial lung changes. Quantitative analysis of emphysema degree using Goddard score and FACT-Digital LungTM software. Quantitative analysis of airway wall thickness using FACT-Digital LungTM software (Pi10). Changes in lung interstitial mass were quantitatively analyzed using InferRead™ CT Lung mean log_jac.
Measured: 12 months，24 months
Secondary outcomes (3)
symptom assessment
Symptom assessment was performed using mMRC scale
Measured: 1 and 12 months, 24 months
symptom assessment K-BILD scale
Symptom assessment was performed using K-BILD scale
Measured: 1 and 12 months, 24 months
symptom assessment CAT scale
Symptom assessment was performed using CAT scale
Measured: 1 and 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start20 May 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Diseases (ILD)Studies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Henan Provincial People's Hospital, Zhejiang University, Zhongshan Hospital (Xiamen), Fudan University, The Affiliated Hospital of Qingdao University, The Affiliated Hospital Of Guizhou Medical University, China-Japan Friendship Hospital, First Hospital of China Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987266
- Sponsor's protocol ID
- 20250507
- Acronym
- EDCS-LIAD
- Status last verified
- Jun 2026
- First submitted
- 7 May 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Diagnosis and Classification System for Lung Interstitial and Airway Diseases (LIAD)
- ClinicalTrials.gov ID
- NCT06987266
- Acronym / sponsor ID
- EDCS-LIAD / 20250507
- Conditions
- Interstitial Lung Diseases (ILD), Airway Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Beijing Hospital, Henan Provincial People's Hospital, Zhejiang University, Zhongshan Hospital (Xiamen), Fudan University, The Affiliated Hospital of Qingdao University, The Affiliated Hospital Of Guizhou Medical University, China-Japan Friendship Hospital, First Hospital of China Medical University
- Study start
- 20 May 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 23 May 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.
This study focuses on both hospitalized and outpatient populations. Through a multicenter, retrospective study, it aims to comprehensively characterize:The comorbidity of interstitial lung diseases (ILD) and airway diseases;The comorbidity of ILD with other intrapulmonary diseases;The comorbidity of airway diseases with other intrapulmonary diseases;The comorbidity of ILD and airway diseases with extrapulmonary diseases.Based on these findings, the study seeks to propose classification and diagnostic criteria for ILD and airway disease comorbidities.Additionally, a multicenter, prospective, disease-specific cohort study will be conducted to observe the prognosis of patients with ILD and/or airway diseases, identify prognostic factors, and grade the severity of comorbid conditions based on these factors.Finally, the study will analyze the current state of interventions and the medical costs associated with ILD and airway disease comorbidities through a cost-effectiveness analysis, aiming to propose new strategies for integrated disease management.
Detailed description
This study is divided into two parts, the first part is a multi-center, retrospective study of 9 units in the past 36 months of medical records (10,000 cases) were analyzed; The second part is a multi-center, prospective, observational cohort study. A total of 900 patients with pulmonary interstitial and airway diseases were enrolled, including hospitalized patients, outpatients, and subjects to be confirmed for 2-year follow-up. The total study period was 4 years (2024 December to 2028 November) .
- A retrospective study was conducted in 9 tertiary hospitals across the country to collect data on cases discharged from respiratory and critical care medicine departments in the previous 36 months (2022 February to February 2025)(about 10,000 cases) , from which cases with a diagnosis of interstitial lung disease, airway disease were screened according to the discharge diagnosis ICD-10 code (disease classification and Code National Clinical Edition 2.0)(Table 1) , the clinical data, chest CT, lung function and intervention measures of the cases were collected to describe the comorbidity and intervention situation of hospitalized pulmonary interstitial and airway diseases in our country, and to put forward the classification and diagnostic criteria of pulmonary interstitial and airway diseases. By collecting data on patients with interstitial lung disease and airway disease who had been hospitalized in the respiratory and critical care unit in the previous 36 months at 9 tertiary hospitals, to describe the distribution of diseases, treatment and medical burden of pulmonary interstitial and airway diseases, pulmonary interstitial diseases, airway diseases and other intrapulmonary diseases, pulmonary interstitial diseases, airway diseases and extrapulmonary diseases in hospitalized patients, etc. , the classification and diagnostic criteria of pulmonary interstitial and airway diseases were proposed.
- A prospective cohort study of comorbidity pulmonary interstitial and airway diseases was conducted in 9 tertiary hospitals across the country. The cohort patients were from three sources, hospitalized in the department of respiratory and critical care medicine, and hospitalized in the department of respiratory and critical care medicine, or outpatient clinics and checkup centers. Part 1 and Part 2: Screening of COPD patients with and without interstitial lung disease, Idiopathic pulmonary fibrosis with and without airway disease, nonspecific interstitial pneumonia with and without airway disease, and pulmonary fibrosis with emphysema in the inpatient and outpatient departments of respiratory and critical care medicine. In the third part, patients with pulmonary interstitial and/or airway diseases requiring respiratory specialist diagnosis in the subject I physical examination population screening, and patients with pulmonary interstitial and/or airway diseases requiring treatment after specialist judgment, were included, the risk factors, clinical information and biological samples of the patients were collected and followed up for 2 years (once every 12 months) . The prognostic information of the patients was collected and the influencing factors related to the prognosis were identified. The severity of comorbidity pulmonary interstitial and airway diseases was graded by analyzing the prognostic factors. By analyzing the intervention status of pulmonary interstitial and airway comorbidity diseases and the cost-effectiveness of medical costs, a new strategy of co-management was proposed. At the same time, it provides data support for the research of the first, fourth, fifth and sixth topic, and provides biological sample support for the third topic.
Clinical data, healthcare resource use, and bio-specimens were collected at baseline and at 2-year follow-up (every 12 months) from 9 Grade III, Class A hospital of respiratory and critical care medicine inpatients, outpatients, and patients with specialty-diagnosed interstitial lung disease and airway disease in the subject 1 physical examination population, to conduct a multi-center, prospective cohort study of comorbidity pulmonary interstitial and airway diseases and identify the influencing factors related to the prognosis of patients with pulmonary interstitial and/or airway diseases. The severity of comorbidity pulmonary interstitial and airway diseases was graded by analyzing the prognostic factors. By analyzing the intervention status of pulmonary interstitial and airway comorbidity diseases and the cost-effectiveness of medical costs, a new strategy of co-management was proposed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| COPD with ILA | – | Other: no interventionChronic obstructive pulmonary disease complicated with interstitial lung abnormalities: patients were treated routinely without additional intervention. |
| PF with emphysema syndrome | – | Other: no interventionPulmonary fibrosis with emphysema syndrome: patients were treated routinely without additional intervention. |
| NSIP | – | Other: no interventionNonspecific interstitial pneumonia: patients were treated routinely without additional intervention. |
| IPF | – | Other: no interventionIdiopathic pulmonary fibrosis: patients were treated routinely without additional intervention. |
| COPD | – | Other: no interventionChronic obstructive pulmonary disease: patients were treated routinely without additional intervention. |
| NSIP with airway disease | – | Other: no interventionNonspecific interstitial pneumonia with airway disease: patients were treated routinely without additional intervention. |
| IPF with airway disease | – | Other: no interventionIdiopathic pulmonary fibrosis with airway disease: patients were treated routinely without additional intervention. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Among the inpatient or outpatient patients in 9 Grade A hospitals, at least 900 patients with COPD combined with/uncombined interstitial lung abnormalities, idiopathic pulmonary fibrosis combined with/uncombined airway disease, nonspecific interstitial pneumonia combined with/uncombined airway disease, pulmonary fibrosis combined with emphysema syndrome.
Key inclusion criteria (5 listed)
- age between 40-80 years old;
- inpatients with an admission diagnosis of COPD, Idiopathic pulmonary fibrosis, nonspecific interstitial pneumonia, patients with the following diagnoses were screened by chest CT (slice thickness ≤1.5 mm) during hospitalization and by in-hospital or prior pulmonary function;
- Inpatients who meet the criteria can complete pulmonary function tests and chest HRCT examinations within one month before expected discharge (excluding hospitalized patients with stable interstitial lung disease or airway disorders);
- among outpatients, patients with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, nonspecific interstitial pneumonia, COPD with pulmonary interstitial abnormalities, idiopathic pulmonary fibrosis with airway lesions, nonspecific interstitial pneumonia with airway lesions, pulmonary fibrosis with emphysema syndrome were diagnosed through chest CT (layer thickness ≤1.5mm) and lung function;
- provide informed consent.
Key exclusion criteria (4 listed)
- expected survival less than 12 months;
- planned lung transplantation or pneumonectomy within 12 months;
- pregnant or lactating women;
- Has previously undergone lobectomy or received thoracic radiotherapy.
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 interventionno ntervention | Other | COPD, COPD with ILA, IPF, IPF with airway disease, NSIP, NSIP with airway disease, PF with emphysema syndrome |
Primary outcome
Number of acute exacerbation
Time frame: 12 months，24 months
Annual rate/value of decline in lung function
Time frame: 12 months，24 months
The main indicators observed for the annual lung function decline rate include △FEV1/pred, △FVC/pred, △DLCO/pred, △FEF50%/pred, △FEF75%/pred, △MMEF/pred; the main indicators observed for the annual lung function decline value include △FEV1, △FVC, △DLCO
Survival status
Time frame: 12 months，24 months
questionnaire
Advances in chest imaging
Time frame: 12 months，24 months
Evaluation indicators of chest imaging advances include emphysema degree , airway wall thickness and Interstitial lung changes. Quantitative analysis of emphysema degree using Goddard score and FACT-Digital LungTM software. Quantitative analysis of airway wall thickness using FACT-Digital LungTM software (Pi10). Changes in lung interstitial mass were quantitatively analyzed using InferRead™ CT Lung mean log_jac.
3 secondary outcomes
symptom assessment
Time frame: 1 and 12 months, 24 months
symptom assessment K-BILD scale
Time frame: 1 and 12 months, 24 months
symptom assessment CAT scale
Time frame: 1 and 12 months, 24 months
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 24 Aug 2026.
- 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 Interstitial Lung Diseases (ILD) and Airway Disease, run by Xiangya Hospital of Central South University 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 5 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 24 Aug 2026. 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 Ruoxi He, MD (86+18874167666, heruoxi@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acute exacerbation (time frame: 12 months，24 months). The study lists 4 primary outcomes in all. 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 24 Aug 2026.