Establishment of Diagnosis and Classification System for Lung Interstitial and Airway Diseases (LIAD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-80
SponsorXiangya Hospital of Central South University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
no intervention
Other interventionno ntervention
Treatment groups
900 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: COPD with ILA1 intervention
Group B: PF with emphysema syndrome1 intervention
Group C: NSIP1 intervention
Group D: IPF1 intervention
Group E: COPD1 intervention
Group F: NSIP with airway disease1 intervention
Group G: IPF with airway disease1 intervention
Trial outcomes
Primary outcomes
1
Number of acute exacerbation
Time frame
12 months，24 months2
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
Time frame
12 months，24 months3
Survival status
questionnaire
Time frame
12 months，24 months4
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.
Time frame
12 months，24 monthsSecondary outcomes
1
symptom assessment
Symptom assessment was performed using mMRC scale
Time frame
1 and 12 months, 24 months2
symptom assessment K-BILD scale
Symptom assessment was performed using K-BILD scale
Time frame
1 and 12 months, 24 months3
symptom assessment CAT scale
Symptom assessment was performed using CAT scale
Time frame
1 and 12 months, 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiangya Hospital of Central South University
Lead sponsor
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
Source ClinicalTrials.gov