Establishment of Diagnosis and Classification System for Lung Interstitial and Airway Diseases (LIAD)

NCT06987266 | Not Yet Recruiting

• 1 other identifier: 20250507
• Study Type: observational
• Target: 900
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Interstitial Lung Diseases (ILD); Airway Disease

Outcome Measures

Primary Outcomes (4)

• Number of acute exacerbation

  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

  12 months，24 months

• Survival status

  questionnaire

  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.

  12 months，24 months

Secondary Outcomes (3)

• symptom assessment

  1 and 12 months, 24 months

• symptom assessment K-BILD scale

  1 and 12 months, 24 months

• symptom assessment CAT scale

  1 and 12 months, 24 months

Study Arms (7)

COPD with ILA

Chronic obstructive pulmonary disease complicated with interstitial lung abnormalities: patients were treated routinely without additional intervention.

Other: no intervention

PF with emphysema syndrome

Pulmonary fibrosis with emphysema syndrome: patients were treated routinely without additional intervention.

Other: no intervention

NSIP

Nonspecific interstitial pneumonia: patients were treated routinely without additional intervention.

Other: no intervention

IPF

Idiopathic pulmonary fibrosis: patients were treated routinely without additional intervention.

Other: no intervention

COPD

Chronic obstructive pulmonary disease: patients were treated routinely without additional intervention.

Other: no intervention

NSIP with airway disease

Nonspecific interstitial pneumonia with airway disease: patients were treated routinely without additional intervention.

Other: no intervention

IPF with airway disease

Idiopathic pulmonary fibrosis with airway disease: patients were treated routinely without additional intervention.

Other: no intervention

Interventions

no intervention OTHER

no ntervention

COPD; COPD with ILA; IPF; IPF with airway disease; NSIP; NSIP with airway disease; PF with emphysema syndrome

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Among the inpatient or outpatient patients in 9 Grade A hospitals, 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.

You may qualify if:

• 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;
• the inpatients could complete pulmonary function and chest CT examination within 1 month after discharge;
• 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.

You may not qualify if:

• expected survival less than 12 months;
• planned lung transplantation or pneumonectomy within 12 months;
• pregnant or lactating women.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Beijing Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• Zhejiang University: collaborator
• Zhongshan Hospital (Xiamen), Fudan University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• China-Japan Friendship Hospital: collaborator
• First Hospital of China Medical University: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum; alveolar lavage fluid; blood; urine; stool

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ruoxi He, MD

CONTACT

86+18874167666; heruoxi@csu.edu.cn

Wei Cheng, MD

CONTACT

86+18274860269; urnotchengwei@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 23, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share