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

Active, not recruiting

• Conditions: IPF

• Registration Number: NCT06714812
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The goal of this observational study is to 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 will consist 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 participation in the study will be obtained. Following the signing of the informed consent, the data of interest for 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.

Study Timeline

• Study Start: 2023-08-20
• Primary Completion: 2023-12-31
• Status Verified: 2024-10
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Caucasian ethnicity;
• Age ≥ 18 years;
• Subjects with a diagnosis of IPF who started antifibrotic therapy with nintedanib on or after 01/06/2020.
• Obtaining written informed consent

Exclusion Criteria

• clinical and functional data not availbale

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of the demographic and clinical characteristics associated with the development of diarrheal adverse events in a Caucasian population with IPF undergoing treatment with nintedanib	18 months	Presence and intensity of diarrheal adverse events defined according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, which defines diarrhea as 'frequent and watery bowel movements' and classifies it into the following grades: Grade 1 = Increase in the number of daily bowel movements \< 4 compared to baseline.; Grade 2 = Increase in the number of daily bowel movements from 4-6 compared to baseline.; Grade 3 = Increase in the number of daily bowel movements \> 7 compared to baseline.; Grade 4 = Requires urgent intervention, life-threatening. Grade 5 = Death

Secondary Outcome Measures

Name	Time	Method
Identification of the functional parameters associated with the temporary dose reduction of nintedanib	18 months	Temporary dose reduction of nintedanib
Evaluation of the proportion of patients requiring a permanent dose reduction of nintedanib (100 mg twice daily) or discontinuation of the drug, and comparison of their characteristics with those patients who did not require therapy modifications.	18 months	Permanent reduction or discontinuation of nintedanib. Dose reduction of nintedanib is defined as the transition from the 'full' dose-equivalent to taking one 150 mg capsule twice daily-to the 'reduced' dose-equivalent to taking one 100 mg capsule twice daily. 'Reduction' and 'discontinuation' of nintedanib are considered two distinct outcomes.
Assessment of the effectiveness of different nintedanib dose reduction strategies in reducing diarrheal symptoms	18 months	Effectiveness of the dose reduction strategy, defined as a decrease of at least 1 grade on the CTCAE scale.
Calculation of the incidence of diarrheal adverse events in a Caucasian population of patients with IPF undergoing antifibrotic treatment with nintedanib during the first year of therapy	18 months	Number of diarrheal adverse events.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliera-Universitaria di Bologna; 🇮🇹 Bologna, Italy