Characteristics of Diarrheal Adverse Events in a Caucasian Population of Patients With Idiopathic Pulmonary Fibrosis Undergoing Treatment With Nintedanib - Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Caucasian ethnicity;
- •Age ≥ 18 years;
- •Subjects with a diagnosis of IPF who started antifibrotic therapy with nintedanib on or after 01/06/
- •Obtaining written informed consent
Exclusion Criteria
- •clinical and functional data not availbale
Outcomes
Primary Outcomes
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
- 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)