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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-20

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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IPF

Keywords

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IPF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefano Nava, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status

Countries

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Italy

Other Identifiers

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EAD-IPF-N

Identifier Type: -

Identifier Source: org_study_id