Status:
COMPLETED
A Study Based on Medical Records in Spain That Looks at Diarrhoea Control in People With Pulmonary Fibrosis Who Are Taking Nintedanib
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Idiopathic Pulmonary Fibrosis
Diarrhoea
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational, non-interventional, and prospective post authorization safety study (PASS) that will describe the real-world proportion of patients that achieve nintedanib-associated diarrho...
Eligibility Criteria
Inclusion
- Inclusion criteria/definition
- Adults (≥18 years old) at diarrhoea initiation.
- Ability to consent and to conduct all procedures of the study, as judged by the study investigator, and agreeing to participate providing informed consent at baseline.
- Diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) (other than IPF), as registered in electronic medical records (EMR) using free text or international statistical classification of diseases and related health problems (ICD) codes (ICD-9 and/or ICD-10), at least 1 day before diarrhoea initiation.
- Being treated with 150 milligram (mg) bid of nintedanib when initiating diarrhoea symptoms, defined as having a nintedanib anatomical therapeutic chemical (ATC) code (L01EX09) or the molecule/commercial name registered in the EMR, for at least 1 day before diarrhoea initiation.
- First pulmonologist consultation (face-to-face) at the time of recruitment due to a first diarrhoea episode as defined by the pulmonologist since nintedanib initiation. Diarrhoea defined as the passage of three or more loose or liquid stools in a 24-hour period (loose or liquid stools defined as stools with a Bristol Stool Form Scale (BSFS) of 6 or 7 points).
- Exclusion criteria
- Patients diagnosed with systemic sclerosis associated interstitial lung disease (SSc-ILD) as registered in EMR using free text or ICD codes (ICD-9 and ICD-10). Referent to any time before or at diarrhoea initiation.
- Participation in any clinical trial including a drug or device at any time before or at diarrhoea initiation.
- Participation in any Patient Support Programme (PSP) at diarrhoea initiation.
- Having history of chronic gastrointestinal disorder (e.g., inflammatory bowel disease or the short gut syndrome), pancreatic dysfunction/insufficiency, or colon cancer; due to the likelihood of faecal incontinence. Referent to any time before or at diarrhoea initiation.
- Having a performance status (PS) ≥3 points on the Eastern Cooperative Oncology Group scale (ECOG) scale at diarrhoea initiation, due to the likelihood of faecal incontinence.
Exclusion
Key Trial Info
Start Date :
July 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 29 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06200714
Start Date
July 16 2024
End Date
April 29 2025
Last Update
June 24 2025
Active Locations (8)
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1
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036
2
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain, 08916
3
Hospital Universitario de Cruces
Bizkaia, Spain, 48903
4
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014