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

Idiopathic Pulmonary Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06200714
• Other study ID #: 1199-0545
• Status: Recruiting
• Start date: April 30, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoea
• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Santiago	A Coruña
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario de Getafe	Madrid
Spain	Hospital Álvaro Cunqueiro	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 weeks
Secondary	Absolute change in the proportion of patients taking optimal nintedanib dose (150 mg bid) at 12- week follow-up referent to diarrhoea initiation		Up to 12 weeks
Secondary	Absolute change in Bristol Stool Form Scale (BSFS) score at week 12 follow-up referent to diarrhoea initiation		Up to 12 weeks
Secondary	Absolute change in number of stools per day at 12- week follow-up referent to diarrhoea initiation		Up to 12 weeks
Secondary	Absolute change in current body weight (in kilograms) at 12-week follow-up referent to diarrhoea initiation		Up to 12 weeks
Secondary	Proportion of patients using carob flour for the treatment of nintedanib-associated diarrhoea at any time from diarrhoea initiation to 12-week follow-up		Up to 12 weeks
Secondary	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)	Up to 12 weeks
Secondary	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).	Up to 12 weeks
Secondary	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		Up to 12 weeks
Secondary	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)		Up to 12 weeks
Secondary	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		Up to 12 weeks

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