Clinical trial NCT06714812: Diarrheal Adverse Events in Caucasian Patients With Idiopathic Pulmonary Fibrosis Undergoing Treatment With Nintedanib
Official title: Characteristics of Diarrheal Adverse Events in a Caucasian Population of Patients With Idiopathic Pulmonary Fibrosis Undergoing Treatment With Nintedanib - Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: IPF
Keywords: IPF
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 18 months
Secondary outcomes:
measure: Identification of the functional parameters associated with the temporary dose reduction of nintedanib
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
measure: Assessment of the effectiveness of different nintedanib dose reduction strategies in reducing diarrheal symptoms
timeFrame: 18 months
measure: 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
timeFrame: 18 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliera-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Stefano Nava, MD
role: PRINCIPAL_INVESTIGATOR
References: