Clinical trial NCT06200714: A Study Based on Medical Records in Spain That Looks at Diarrhoea Control in People With Pulmonary Fibrosis Who Are Taking Nintedanib
Official title: Observational, Multicentre, Prospective, Real-world Post-authorization Safety Study Describing the Achievement of Nintedanib-associated DIArrhoea Control After 12 Weeks of Follow-up in Patients With Idiopathic puLmonary FIBrosis (IPF) and Progressive Pulmonary Fibrosis (Other Than IPF) in Spain: the DIALFIB Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Diarrhoea
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-01-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinical management of interstitial lung diseases (IPF) or other progressive pulmonary fibrosis (PPF) patients who experienced nintedanib-associated diarrhoea.

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Achievement of diarrhoea control (yes/no)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Absolute change in the proportion of patients taking optimal nintedanib dose (150 mg bid) at 12- week follow-up referent to diarrhoea initiation
timeFrame: Up to 12 weeks
measure: Absolute change in Bristol Stool Form Scale (BSFS) score at week 12 follow-up referent to diarrhoea initiation
timeFrame: Up to 12 weeks
measure: Absolute change in number of stools per day at 12- week follow-up referent to diarrhoea initiation
timeFrame: Up to 12 weeks
measure: Absolute change in current body weight (in kilograms) at 12-week follow-up referent to diarrhoea initiation
timeFrame: Up to 12 weeks
measure: Proportion of patients using carob flour for the treatment of nintedanib-associated diarrhoea at any time from diarrhoea initiation to 12-week follow-up
timeFrame: Up to 12 weeks
measure: Number of patients per treatment category for nintedanib-associated diarrhoea at diarrhoea initiation
timeFrame: Up to 12 weeks
measure: Number of patients per treatment category for nintedanib-associated diarrhoea at 12-week follow-up
timeFrame: Up to 12 weeks
measure: 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
timeFrame: Up to 12 weeks
measure: 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)
timeFrame: Up to 12 weeks
measure: 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
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Bizkaia
country: Spain
facility: Hospital Universitario de Cruces
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Pontevedra
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
References: