Idiopathic Pulmonary Fibrosis Registry China Study

Dai Huaping800 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

Idiopathic Pulmonary Fibrosis

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Huaping Dai

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Demographic and clinical characteristic of newly diagnosed Chinese IPF patients

Data analyses will be mainly descriptive.

Time frame: up to 5 years

Secondary Outcomes

Mortality in Chinese patients with IPF

Mortality will be showed as percentage.

Time frame: up to 5 years

Cause of death in Chinese patients with IPF

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.

Time frame: up to 5 years

Progression-free survival in Chinese patients with IPF

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.

Time frame: up to 5 years

Description of the acute exacerbations in Chinese patients with IPF

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.

Data from ClinicalTrials.gov

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