IPF Italian Observational Study (FIBRONET) in Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Study type: Observational

Funder types: Industry

Identifiers

NCT02803580

1199.262

Details and patient eligibility

About

The purpose of the present study is to evaluate the characteristics, management and clinical course of patients with IPF as treated under real-world in Italian Pulmonary Centres, in terms of symptoms, lung function and exercise tolerance during 12 months of observation.

Enrollment: 209 patients

Sex: All

Ages: 40 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged>=40 years

2. Written informed consent to both participation in the study and privacy

3. Physician diagnosed IPF during the last 3 months based upon recent American Thoracic Society/European Resp. Society/Japanese Resp. Society/Latin American Thoracic Association guidelines 2011 (see Tables A1-A2 for High Resolution Chest Computer Tomography and histology criteria):

   • Exclusion of other known causes of Interstitial Lung Disease (e.g. domestic and occupational environmental exposures, connective tissue disease and drug toxicity)
   • Assessment of Idiopathic Pulmonary Fibrosis based on High Resolution Computed Tomography (HRCT) or HRCT and surgical lung biopsy if available.

4. Patient with further follow-up possible with enrolling investigator during planned study period

5. Patients capable of discernment and able to read or write in Italian language.

Exclusion criteria

1. Inclusion in clinical trials or other IPF/ILD registries
2. Lung transplantation expected within the next 6 months
3. Pregnancy or breast feeding

Trial design