Idiopathic Pulmonary Fibrosis Registry China Study

• Conditions: Idiopathic Pulmonary Fibrosis

• Registration Number: NCT03666234
• Lead Sponsor: Dai Huaping

Brief Summary

By mean of registry of newly diagnosed Chinese IPF patients from more than 15 sites, this study aims to build IPF prospective cohort, set up normative clinical database and a biological specimen bank, and examine the clinical characteristics of newly diagnosed Chinese IPF patients, as well as the nature history, prognosis, comorbidities and complications of IPF patients in China, the current treatment pattern, burden of illness, and quality of life of Chinese IPF patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-20
• Study Start: 2018-07-01
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-10
• Last Update Submitted: 2018-09-10
• Study First Posted: 2018-09-11
• Last Update Posted: 2018-09-11
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011
• Aged 40 years and above at recruitment
• Willing and able to sign an informed consent

Exclusion Criteria

• Inclusion in any interventional clinical trials
• Lung transplantation expected within the next 6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographic and clinical characteristic of newly diagnosed Chinese IPF patients	up to 5 years	Data analyses will be mainly descriptive.

Secondary Outcome Measures

Name	Time	Method
Cause of death in Chinese patients with IPF	up to 5 years	Cause of death: a. IPF-related: i. Respiratory failure: Pulmonary failure leads to impaired gas exchange, i.e. hypoxemia and/or hypercapnia ii. Acute exacerbation of IPF (as defined below) iii. Other aspects related to IPF (please specify); b. Concomitant conditions: i. Coronary heart disease ii. Cerebrovascular disease iii. Pneumonia/respiratory tract infection iv. Pulmonary embolism v. Pulmonary hypertension or pulmonary hypertension/right heart failure vi. Lung cancer; c. Other causes; d. Unknown.; Cause of death will be showed as categorical variable, and the counts and percentile ratios will be statistically counted.
Progression-free survival in Chinese patients with IPF	up to 5 years	Patients without the following events: 1. Death; 2. Lung transplantation; 3. Acute exacerbation; 4. Require long-term oxygen therapy; 5. Hospitalization for respiratory reasons; The unit of progression-free survival is day.
Mortality in Chinese patients with IPF	up to 5 years	Mortality will be showed as percentage.
Description of the acute exacerbations in Chinese patients with IPF	up to 5 years	Acute exacerbation of IPF (AE-IPF); 1. Previous diagnosis or simultaneous diagnosis of IPF; 2. Symptoms generally manifest as dyspnea with acute exacerbations or progression within 1 month; 3. Chest CT shows new bilateral glass ground or solid shadows on the basis of usual interstitial pneumonia (UIP); 4. Exacerbations cannot be completely explained by heart failure or increased volume load.; The incidence of the acute exacerbation will be showed as percentage.

Trial Locations

Locations (1)

Huaping Dai; 🇨🇳 Beijing, Beijing, China