A Study Based on Medical Records in Spain That Looks at Diarrhoea Control in People With Pulmonary Fibrosis Who Are Taking Nintedanib

N/ACompletedNCT06200714

Boehringer Ingelheim17 enrolled

Overview

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 diarrhoea control after 12 weeks of follow-up, in hospital settings in Spain. It will include outpatients (i.e., those attending ambulatory visits) with interstitial lung diseases (IPF) and other progressive pulmonary fibrosis (PPF) treated with nintedanib (150 mg bid) and having a first episode of diarrhoea after nintedanib initiation.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Idiopathic Pulmonary Fibrosis Diarrhoea

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 1. 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. 2. Participation in any clinical trial including a drug or device at any time before or at diarrhoea initiation. 3. Participation in any Patient Support Programme (PSP) at diarrhoea initiation. 4. 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. 5. 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.

Locations (8)

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain

Hospital Universitari Germans Trias i Pujol

Barcelona, Spain

Hospital Universitario de Cruces

Bizkaia, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital de La Princesa

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Álvaro Cunqueiro

Pontevedra, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Outcomes

Primary Outcomes

Achievement of diarrhoea control (yes/no)

Achievement of diarrhoea control (yes/no), defined as the passage of less than 3 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 while being treated with 150 mg bid of nintedanib, at 12-week follow-up.

Time frame: Up to 12 weeks

Secondary Outcomes

Absolute change in the proportion of patients taking optimal nintedanib dose (150 mg bid) at 12- week follow-up referent to diarrhoea initiation

Time frame: Up to 12 weeks

Absolute change in Bristol Stool Form Scale (BSFS) score at week 12 follow-up referent to diarrhoea initiation

Time frame: Up to 12 weeks

Absolute change in number of stools per day at 12- week follow-up referent to diarrhoea initiation

Time frame: Up to 12 weeks

Absolute change in current body weight (in kilograms) at 12-week follow-up referent to diarrhoea initiation

Time frame: Up to 12 weeks

Proportion of patients using carob flour for the treatment of nintedanib-associated diarrhoea at any time from diarrhoea initiation to 12-week follow-up

Time frame: Up to 12 weeks

Number of patients per treatment category for nintedanib-associated diarrhoea at diarrhoea initiation

Treatment categories of nintedanib-associated diarrhoea could include pharmacological treatments (e.g., loperamide) or non-pharmacological treatment (e.g., carob flour, zinc, probiotics, other dietary interventions, hydration)

Time frame: Up to 12 weeks

Number of patients per treatment category for nintedanib-associated diarrhoea at 12-week follow-up

Treatment categories of nintedanib-associated diarrhoea could include harmacological treatments (e.g., loperamide) or non-pharmacological treatment (e.g., carob flour, zinc, probiotics, other dietary interventions, hydration).

Time frame: Up to 12 weeks

Occurrence of at least one dose reduction (yes/no), defined as reduction of nintedanib dose from 150 mg bid to 100 mg bid, from diarrhoea initiation to 12-week follow-up

Time frame: Up to 12 weeks

Occurrence of permanent withdrawal, defined as discontinuing 150 mg bid or 100 mg bid of nintedanib and not reintroducing it before the 12- week follow-up)

Time frame: Up to 12 weeks

Occurrence of at least one dose escalation (yes/no), defined as an increase of nintedanib dose from 100 mg bid to 150 mg bid from diarrhoea initiation to 12-week follow-up

Time frame: Up to 12 weeks