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

NCT06714812 | Active Not Recruiting

• 1 other identifier: EAD-IPF-N
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IPF

Keywords

IPF

Outcome Measures

Primary Outcomes (1)

• 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

  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

  18 months

Secondary Outcomes (4)

• Identification of the functional parameters associated with the temporary dose reduction of nintedanib

  18 months

• 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

• Assessment of the effectiveness of different nintedanib dose reduction strategies in reducing diarrheal symptoms

  18 months

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Nintedanib for IPF who are seen 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.

You may qualify if:

• 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

You may not qualify if:

• clinical and functional data not availbale

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Study Officials

• Stefano Nava, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 4, 2024
• Study Start: August 20, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

IT (1)