A Study Based on Medical Records in Spain That Looks at Diarrhoea Control in People With Pulmonary Fibrosis Who Are Taking Nintedanib
- Conditions
- Idiopathic Pulmonary FibrosisDiarrhoea
- Registration Number
- NCT06200714
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Achievement of diarrhoea control (yes/no) Up to 12 weeks 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.
- Secondary Outcome Measures
Name Time Method 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 Absolute change in number of stools per day at 12- week follow-up referent to diarrhoea initiation 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 Up to 12 weeks Number of patients per treatment category for nintedanib-associated diarrhoea at diarrhoea initiation Up to 12 weeks 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)
Absolute change in Bristol Stool Form Scale (BSFS) score at week 12 follow-up referent to diarrhoea initiation Up to 12 weeks Absolute change in current body weight (in kilograms) at 12-week follow-up referent to diarrhoea initiation Up to 12 weeks Number of patients per treatment category for nintedanib-associated diarrhoea at 12-week follow-up Up to 12 weeks 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).
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 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 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
Trial Locations
- Locations (8)
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
Hospital Universitario de Cruces
🇪🇸Bizkaia, Spain
Hospital Clínic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Barcelona, Spain