Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Fibrosis

Treatments: Drug: pirfenidone; Drug: nintedanib

Study type: Observational

Funder types: Industry

Identifiers

NCT03242759

1199-0303

Details and patient eligibility

About

This is a non-interventional, multi-center study to collect data from patients with idiopathic pulmonary fibrosis (IPF) in clinical practice in Taiwan. The study will be carried out at 10 medical centers, the expert centers where IPF patients are mainly managed in Taiwan.

Enrollment: 101 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients can be included if ALL the following criteria are met:

  1.Newly diagnosed with IPF within 6 months based upon recent ATS/ERS/JRS/ALAT IPF guideline (Ref 1, Raghu G, et al. 2011).

• Exclusion of other known causes of ILD (e.g. domestic and occupational environmental exposures, connective tissue disease, and drug toxicity).

• Assessment of IPF based on HRCT or HRCT and surgical lung biopsy, if available. 2.Patient ≥ 20 years of age 3.Written informed consent prior to participation 4.Patients with further follow-up possible with participating physician during planned study period 5.Ability to read and write in the local language

Exclusion criteria

• Patients should not be included if ANY of the following criteria is met:

  1. Lung transplantation expected within next 6 months.
  2. Inclusion in ongoing clinical trials.

Trial design

101 participants in 1 patient group

patients with idiopathic pulmonary fibrosis (IPF)

Treatment:

Drug: nintedanib

Drug: pirfenidone