Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06714812

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

IPF

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: 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 outcomes

  1. Identification of the functional parameters associated with the temporary dose reduction of nintedanib

    Time frame: 18 months

    Temporary dose reduction of nintedanib

  2. 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.

    Time frame: 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.

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

    Time frame: 18 months

    Effectiveness of the dose reduction strategy, defined as a decrease of at least 1 grade on the CTCAE scale.

  4. 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

    Time frame: 18 months

    Number of diarrheal adverse events.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: EAD-IPF-N

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.