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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Idiopathic Pulmonary Fibrosis
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 17
- Locations
- 8
- Primary Endpoint
- Achievement of diarrhoea control (yes/no)
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Achievement of diarrhoea control (yes/no)
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)