N/A
Completed N=18
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 · Diarrhoea
Source: ClinicalTrials.gov NCT06200714 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Achievement of Diarrhoea Control at Week 12 Follow-up While Taking the Optimal Nintedanib Dose — 70.59 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achievement of Diarrhoea Control at Week 12 Follow-up While Taking the Optimal Nintedanib Dose |
70.59 | — |
| SECONDARY Absolute Change in the Proportion of Participants Taking the Optimal Nintedanib Dose at Week 12 Follow-up |
76.47 | — |
| SECONDARY Absolute Change From Baseline in BSFS Score at Week 12 Follow-up |
-1.76 | — |
| SECONDARY Absolute Change From Baseline in Number of Stools Per Day at Week 12 Follow-up |
-2.09 | — |
| SECONDARY Absolute Change From Baseline in Current Body Weight at Week 12 Follow-up |
-0.66 | — |
| SECONDARY Proportion of Participants Who Used Carob Flour for the Treatment of Nintedanib-associated Diarrhoea |
88.24 | — |
| SECONDARY Number of Participants Per Treatment Category for Nintedanib-associated Diarrhoea at Diarrhoea Initiation |
0; 9; 3 | — |
| SECONDARY Number of Participants Per Treatment Category for Nintedanib-associated Diarrhoea at Week 12 Follow-up |
1; 11; 2 | — |
| SECONDARY Occurrence of at Least One Nintedanib Dose Reduction From Diarrhoea Initiation to Week 12 Follow-up |
4 | — |
| SECONDARY Occurrence of Permanent Withdrawal of Nintedanib |
4 | — |
| SECONDARY Occurrence of at Least One Nintedanib Dose Escalation From Diarrhoea Initiation to 12-week Follow-up |
4 | — |
Eligibility Criteria
Inclusion criteria
- 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
- 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.
- Participation in any clinical trial including a drug or device at any time before or at diarrhoea initiation.
- Participation in any Patient Support Programme (PSP) at diarrhoea initiation.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT06200714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.