NCT06714812

Diarrheal Adverse Events in Caucasian Patients With Idiopathic Pulmonary Fibrosis Undergoing Treatment With Nintedanib

Characteristics of Diarrheal Adverse Events in a Caucasian Population of Patients With Idiopathic Pulmonary Fibrosis Undergoing Treatment With Nintedanib - Pilot Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to identify the demographic and clinical characteristics associated with the development of diarrheal adverse events in a Caucasian population with IPF undergoing treatment with nintedanib. Additionally this study aims to evaluate the different therapeutic strategies for dose reduction of nintedanib and assess the effectiveness of these strategies in reducing the occurrence of diarrhea.

Detailed description

The study population consists of patients treated with Nintedanib for IPF who are followed at the Interstitial Lung Disease Outpatient Clinic of the Pneumology and Respiratory Intensive Care Unit at the IRCCS Azienda Ospedaliero-Universitaria of Bologna, Policlinico di Sant'Orsola, and who have received the treatment for at least 12 consecutive months. At the first available visit (which will be conducted according to the routine follow-up schedule), informed consent for partecipation in the study will be obtained. Following the signing of the informed consent, the data relevant to the protocol will be collected retrospectively, concerning the visit at which nintedanib therapy was initiated and the follow-up visits conducted at 6 and 12 months from the start of the antifibrotic therapy, as per clinical practice.

Conditions

• IPF

Timeline

• Start date: 2023-08-20
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2024-12-04
• Last updated: 2025-12-19

Locations

1 site across 1 country: Italy