An observational study in Idiopathic Pulmonary Fibrosis and Diarrhoea, sponsored by Boehringer Ingelheim. Completed at 8 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Boehringer Ingelheim · Observational
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.
551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's enrollment of 18 is below the median of 158 across 154 observational studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Clinical management of interstitial lung diseases (IPF) or other progressive pulmonary fibrosis (PPF) patients who experienced nintedanib-associated diarrhoea.
Exclusion criteria
Participants with idiopathic pulmonary fibrosis (IPF) or other progressive pulmonary fibrosis (PPF) who experienced treatment-associated diarrhoea while being treated with 150 milligrams (mg) nintedanib twice daily. Participants were observed for 12 weeks from the time of first diarrhoea occurrence.
Drug: Nintedanib
Participants received 150 milligrams (mg) Nintedanib, twice daily.
Also known as: OFEV
Achievement of Diarrhoea Control at Week 12 Follow-up While Taking the Optimal Nintedanib Dose
The percentage of participants who achieved diarrhoea control while taking the optimal nintedanib dose (150 milligrams, twice a day) at 12-week follow-up referent to diarrhoea initiation is described. Achievement of diarrhoea control (yes/no) is defined as the passage of fewer than 3 loose or liquid stools in a 24-hour period. Loose or liquid stools were defined as stools with a Bristol Stool Form Scale (BSFS) score of 6 or 7. The BSFS classifies stool into seven categories based on their consistency. The scale ranges from 1 (hard, separate lumps) to 7 (entirely liquid), with scores 1 and 2 indicating constipation and scores 6 and 7 indicating diarrhoea.
Time frame: 12 weeks after baseline visit.
Absolute Change in the Proportion of Participants Taking the Optimal Nintedanib Dose at Week 12 Follow-up
The proportion of participants, presented as percentage, taking the optimal nintedanib dose (150 milligrams, twice a day) at 12-week follow-up referent to diarrhoea initiation is described.
Time frame: 12 weeks after baseline visit.
Absolute Change From Baseline in BSFS Score at Week 12 Follow-up
The absolute change in Bristol Stool Form Scale (BSFS) score at the 12-week follow-up, as compared to the baseline visit, is reported. The BSFS classifies stool into seven categories based on their consistency. The scale ranges from 1 (hard, separate lumps) to 7 (entirely liquid), with scores 1 and 2 indicating constipation and scores 6 and 7 indicating diarrhoea. The baseline value was measured referent to the day of diarrhoea initiation, while the Week 12 timepoint was measured as the mean value from the last 7 days.
Time frame: At baseline and at Week 12.
Absolute Change From Baseline in Number of Stools Per Day at Week 12 Follow-up
The absolute change from baseline in number of stools per day at 12-week follow-up is reported. The baseline value was measured referent to the day of diarrhoea initiation, while the Week 12 timepoint value was collected as a mean number per patient in the last 7 days.
Time frame: At baseline and at Week 12.
Absolute Change From Baseline in Current Body Weight at Week 12 Follow-up
The absolute change from baseline in current body weight (kilograms) at Week 12 follow-up is reported. The baseline value was measured referent to the day of diarrhoea initiation, while the Week 12 timepoint was measured as the mean value from the last 7 days.
Time frame: At baseline and at Week 12.
Proportion of Participants Who Used Carob Flour for the Treatment of Nintedanib-associated Diarrhoea
The proportion of participants, presented as percentage, who used carob flour for the treatment of nintedanib-associated diarrhoea at any time from diarrhoea initiation to Week 12 follow-up is reported.
Time frame: From baseline visit, up to 12 weeks.
Number of Participants Per Treatment Category for Nintedanib-associated Diarrhoea at Diarrhoea Initiation
The number of participants per treatment category for nintedanib-associated diarrhea is reported. Treatment categories of nintedanib-associated diarrhoea include pharmacological treatments (e.g., loperamide, oral rehydration salt formulations, tannate), non-pharmacological treatments (e.g., carob flour, zinc, probiotics, other dietary interventions, hydration), and a combination of both pharmacological and non-pharmacological treatments.
Time frame: At baseline visit.
Number of Participants Per Treatment Category for Nintedanib-associated Diarrhoea at Week 12 Follow-up
The number of participants per treatment category for nintedanib-associated diarrhea is reported. Treatment categories of nintedanib-associated diarrhoea include pharmacological treatments (e.g., loperamide, oral rehydration salt formulations, tannate), non-pharmacological treatments (e.g., carob flour, zinc, probiotics, other dietary interventions, hydration), and a combination of both pharmacological and non-pharmacological treatments.
Time frame: 12 weeks after baseline visit.
Occurrence of at Least One Nintedanib Dose Reduction From Diarrhoea Initiation to Week 12 Follow-up
The occurrence of at least one nintedanib dose reduction is reported as the number of study participants, among those who changed their nintedanib dose, who had at least one dose reduction of nintedanib over the course of the study. Dose reduction is defined as a reduction from 150 milligrams, twice daily to 100 milligrams, twice daily.
Time frame: From baseline visit, up to 12 weeks.
Occurrence of Permanent Withdrawal of Nintedanib
The occurrence of permanent withdrawal of nintedanib is reported as the number of participants who permanently withdrew nintedanib treatment between diarrhoea initiation and 12-week follow-up. Permanent withdrawal is defined as discontinuing nintedanib treatment (either 150 milligrams or 100 milligrams, twice daily) and not reintroducing it before the 12-week follow-up.
Time frame: From baseline visit, up to 12 weeks
Occurrence of at Least One Nintedanib Dose Escalation From Diarrhoea Initiation to 12-week Follow-up
The occurrence of at least one nintedanib dose escalation is reported as the number of participants who had at least one nintedanib dose escalation from diarrhoea initiation to 12-week follow-up. Dose escalation is defined as an increase of nintedanib dose from 100 milligrams to 150 milligrams, twice daily.
Time frame: From baseline visit, up to 12 weeks
This was an observational, post authorization safety study based on newly collected data in patients in Spain with idiopathic pulmonary fibrosis (IPF) and other progressive pulmonary fibrosis (PPF) who were treated with 150 milligrams (mg) of nintedanib twice daily and had suffered a first episode of nintedanib-associated diarrhoea. The study baseline was the first pulmonologist visit due to a first episode of diarrhoea after the initiation of nintedanib treatment.
| Milestone | IPF/PPF Participants |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
The proportion of participants, presented as percentage, taking the optimal nintedanib dose (150 milligrams, twice a day) at 12-week follow-up referent to diarrhoea initiation is described.
| Percentage of participants | IPF/PPF Participants |
|---|---|
| Absolute Change in the Proportion of Participants Taking the Optimal Nintedanib Dose at Week 12 Follow-up | 76.47 |
The absolute change in Bristol Stool Form Scale (BSFS) score at the 12-week follow-up, as compared to the baseline visit, is reported. The BSFS classifies stool into seven categories based on their consistency. The scale ranges from 1 (hard, separate lumps) to 7 (entirely liquid), with scores 1 and 2 indicating constipation and scores 6 and 7 indicating diarrhoea. The baseline value was measured referent to the day of diarrhoea initiation, while the Week 12 timepoint was measured as the mean value from the last 7 days.
| Score on a scale | IPF/PPF Participants |
|---|---|
| Absolute Change From Baseline in BSFS Score at Week 12 Follow-up | -1.76 ± 1.60 |
The absolute change from baseline in number of stools per day at 12-week follow-up is reported. The baseline value was measured referent to the day of diarrhoea initiation, while the Week 12 timepoint value was collected as a mean number per patient in the last 7 days.
| Stools per day | IPF/PPF Participants |
|---|---|
| Absolute Change From Baseline in Number of Stools Per Day at Week 12 Follow-up | -2.09 ± 1.27 |
The absolute change from baseline in current body weight (kilograms) at Week 12 follow-up is reported. The baseline value was measured referent to the day of diarrhoea initiation, while the Week 12 timepoint was measured as the mean value from the last 7 days.
| Kilograms | IPF/PPF Participants |
|---|---|
| Absolute Change From Baseline in Current Body Weight at Week 12 Follow-up | -0.66 ± 1.93 |
The proportion of participants, presented as percentage, who used carob flour for the treatment of nintedanib-associated diarrhoea at any time from diarrhoea initiation to Week 12 follow-up is reported.
| Percentage of participants | IPF/PPF Participants |
|---|---|
| Proportion of Participants Who Used Carob Flour for the Treatment of Nintedanib-associated Diarrhoea | 88.24 |
The number of participants per treatment category for nintedanib-associated diarrhea is reported. Treatment categories of nintedanib-associated diarrhoea include pharmacological treatments (e.g., loperamide, oral rehydration salt formulations, tannate), non-pharmacological treatments (e.g., carob flour, zinc, probiotics, other dietary interventions, hydration), and a combination of both pharmacological and non-pharmacological treatments.
| Participants | IPF/PPF Participants |
|---|---|
| Only Pharmacological | 0 |
| Only Non-Pharmacological | 9 |
| Both Pharmacological and Non-Pharmacological | 3 |
The number of participants per treatment category for nintedanib-associated diarrhea is reported. Treatment categories of nintedanib-associated diarrhoea include pharmacological treatments (e.g., loperamide, oral rehydration salt formulations, tannate), non-pharmacological treatments (e.g., carob flour, zinc, probiotics, other dietary interventions, hydration), and a combination of both pharmacological and non-pharmacological treatments.
| Participants | IPF/PPF Participants |
|---|---|
| Only Pharmacological | 1 |
| Only Non-Pharmacological | 11 |
| Both Pharmacological and Non-Pharmacological | 2 |
The occurrence of at least one nintedanib dose reduction is reported as the number of study participants, among those who changed their nintedanib dose, who had at least one dose reduction of nintedanib over the course of the study. Dose reduction is defined as a reduction from 150 milligrams, twice daily to 100 milligrams, twice daily.
| Participants | IPF/PPF Participants |
|---|---|
| Occurrence of at Least One Nintedanib Dose Reduction From Diarrhoea Initiation to Week 12 Follow-up | 4 |
The occurrence of permanent withdrawal of nintedanib is reported as the number of participants who permanently withdrew nintedanib treatment between diarrhoea initiation and 12-week follow-up. Permanent withdrawal is defined as discontinuing nintedanib treatment (either 150 milligrams or 100 milligrams, twice daily) and not reintroducing it before the 12-week follow-up.
| Participants | IPF/PPF Participants |
|---|---|
| Occurrence of Permanent Withdrawal of Nintedanib | 4 |
The occurrence of at least one nintedanib dose escalation is reported as the number of participants who had at least one nintedanib dose escalation from diarrhoea initiation to 12-week follow-up. Dose escalation is defined as an increase of nintedanib dose from 100 milligrams to 150 milligrams, twice daily.
| Participants | IPF/PPF Participants |
|---|---|
| Occurrence of at Least One Nintedanib Dose Escalation From Diarrhoea Initiation to 12-week Follow-up | 4 |
The percentage of participants who achieved diarrhoea control while taking the optimal nintedanib dose (150 milligrams, twice a day) at 12-week follow-up referent to diarrhoea initiation is described. Achievement of diarrhoea control (yes/no) is defined as the passage of fewer than 3 loose or liquid stools in a 24-hour period. Loose or liquid stools were defined as stools with a Bristol Stool Form Scale (BSFS) score of 6 or 7. The BSFS classifies stool into seven categories based on their consistency. The scale ranges from 1 (hard, separate lumps) to 7 (entirely liquid), with scores 1 and 2 indicating constipation and scores 6 and 7 indicating diarrhoea.
| Percentage of participants | IPF/PPF Participants |
|---|---|
| Achievement of Diarrhoea Control at Week 12 Follow-up While Taking the Optimal Nintedanib Dose | 70.59 |
Collected over From baseline visit until end of follow-up, up to 94 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IPF/PPF Participants | 0/18 (0%) | 0/18 (0%) | 2/18 (11.1%) |
| Event | IPF/PPF Participants |
|---|---|
| DiarrhoeaGastrointestinal disorders | 2/18 |
All patients who signed the informed consent and were enrolled in the study.
| Age, Continuous(Years) | IPF/PPF Participants |
|---|---|
| Mean | 70.28 ± 6.88 |
| Sex: Female, Male(Participants) | IPF/PPF Participants |
|---|---|
| Female | 4 |
| Male | 14 |
| Race/Ethnicity, Customized(Participants) | IPF/PPF Participants |
|---|---|
| Latino | 1 |
| White | 16 |
| Black | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Once the criteria in section 'time frame frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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