Diarrheal Adverse Events in Caucasian Patients With Idiopathic Pulmonary Fibrosis Undergoing Treatment With Nintedanib
NCT06714812 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2025-12-19
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
Sponsors & Collaborators
-
IRCCS Azienda Ospedaliero-Universitaria di Bologna
lead OTHER
Principal Investigators
-
Stefano Nava, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-20
- Primary Completion
- 2023-12-31
- Completion
- 2025-12-31
Countries
- Italy
Study Locations
More Related Trials
-
A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
NCT03099187 ·Status: COMPLETED ·Phase: PHASE2
-
All-Case Surveillance of Ofev in Patients With IPF in Japan
NCT02607722 ·Status: COMPLETED
-
Efficacy & Safety of Nintedanib in Patients With Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease
NCT05067517 ·Status: WITHDRAWN ·Phase: PHASE3
-
Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain
NCT03281200 ·Status: COMPLETED
-
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
NCT06329401 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis
NCT04312594 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)
NCT00662805 ·Status: COMPLETED
-
A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD
NCT02986321 ·Status: COMPLETED ·Phase: PHASE2
-
Real-Life Use of Anti-fibrotic Drugs in Patients With Idiopathic Pulmonary Fibrosis in Sweden
NCT04019080 ·Status: UNKNOWN
-
An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities
NCT03843892 ·Status: APPROVED_FOR_MARKETING
-
Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)
NCT00821093 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)
NCT01089127 ·Status: COMPLETED ·Phase: PHASE3
-
A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients
NCT02671942 ·Status: TERMINATED ·Phase: PHASE2
-
Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993 in Healthy Volunteers
NCT02743013 ·Status: COMPLETED ·Phase: PHASE1
-
The BALANCE Study: A Study in Spain to Find Out Whether a Patient Support Program Helps People With Pulmonary Fibrosis Who Take Nintedanib
NCT06912659 ·Status: ACTIVE_NOT_RECRUITING
-
Study in Patients With COPD
NCT00215423 ·Status: COMPLETED ·Phase: PHASE2
-
Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease
NCT06714123 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis
NCT06736990 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)
NCT03725852 ·Status: COMPLETED ·Phase: PHASE2
-
Study in Patients With COPD
NCT00215384 ·Status: COMPLETED ·Phase: PHASE2
-
A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)
NCT00392587 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough
NCT04030026 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT05743075 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
NCT06025578 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Oral Cyclosporine in Chronic Obstructive Pulmonary Disease
NCT00974142 ·Status: COMPLETED ·Phase: PHASE1/PHASE2