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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPF/PPF Participants | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | Participants received 150 milligrams (mg) Nintedanib, twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after baseline visit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after baseline visit. |
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Inclusion criteria
Exclusion criteria
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Clinical management of interstitial lung diseases (IPF) or other progressive pulmonary fibrosis (PPF) patients who experienced nintedanib-associated diarrhoea.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic i Provincial de Barcelona | Barcelona | 08036 | Spain | |||
| Hospital Universitari Germans Trias i Pujol |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents upon signing of a 'Document Sharing Agreement'. For study data 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. During the recruitment period, 20 participants were initially screened, with 18 considered for enrollment. One participant was excluded from the analysis set due to not fulfilling all inclusion criteria.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | IPF/PPF Participants | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 29, 2024 | Mar 30, 2026 |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From baseline visit, up to 12 weeks |
| Barcelona |
| 08916 |
| Spain |
| Hospital Universitario de Cruces | Bizkaia | 48903 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital de La Princesa | Madrid | 28006 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Álvaro Cunqueiro | Pontevedra | 36312 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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All patients who signed the informed consent and were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | IPF/PPF Participants | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Analysis set: all participants who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. One of the 18 enrolled participants was excluded due to not fulfilling the inclusion criteria. | Posted | Number | Percentage of participants | 12 weeks after baseline visit. |
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| Secondary | 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. | Analysis set: all participants who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. One of the 18 enrolled participants was excluded due to not fulfilling the inclusion criteria. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and at Week 12. |
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| Secondary | 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. | Analysis set: all participants who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. One of the 18 enrolled participants was excluded due to not fulfilling the inclusion criteria. | Posted | Mean | Standard Deviation | Stools per day | At baseline and at Week 12. |
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| Secondary | 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. | Analysis set: all participants who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. One of the 18 enrolled participants was excluded due to not fulfilling the inclusion criteria. | Posted | Mean | Standard Deviation | Kilograms | At baseline and at Week 12. |
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| Secondary | 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. | Analysis set: all participants who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. One of the 18 enrolled participants was excluded due to not fulfilling the inclusion criteria. | Posted | Number | Percentage of participants | From baseline visit, up to 12 weeks. |
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| Secondary | 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. | Analysis set: all participants who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. One of the 18 enrolled participants was excluded due to not fulfilling the inclusion criteria. Only participants who were undergoing treatment for nintedanib-associated diarrhoea at the time of baseline visit were included in the analysis. | Posted | Count of Participants | Participants | At baseline visit. |
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| |||||||||||||||||||||||||||
| Secondary | 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. | Analysis set: all participants who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. One of the 18 enrolled participants was excluded due to not fulfilling the inclusion criteria. Only participants under treatment for nintedanib-associated diarrhoea at the time of 12 week follow-up were included in the analysis. | Posted | Count of Participants | Participants | 12 weeks after baseline visit. |
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| Secondary | 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. | Analysis set: all participants who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. One of the 18 enrolled participants was excluded due to not fulfilling the inclusion criteria. Only participants who changed their nintedanib dose were included in this analysis. | Posted | Count of Participants | Participants | From baseline visit, up to 12 weeks. |
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| Secondary | 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. | Analysis set: all participants who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. One of the 18 enrolled participants was excluded due to not fulfilling the inclusion criteria. Only participants who changed their nintedanib dose were included in this analysis. | Posted | Count of Participants | Participants | From baseline visit, up to 12 weeks |
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| Secondary | 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. | Analysis set: all participants who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. One of the 18 enrolled participants was excluded due to not fulfilling the inclusion criteria. Only participants who changed their nintedanib dose were included in this analysis. | Posted | Count of Participants | Participants | From baseline visit, up to 12 weeks |
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| Primary | 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. | Analysis set: all participants who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. One of the 18 enrolled participants was excluded due to not fulfilling the inclusion criteria. | Posted | Number | Percentage of participants | 12 weeks after baseline visit. |
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From baseline visit until end of follow-up, up to 94 days.
All patients who signed the informed consent and were enrolled in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IPF/PPF Participants | 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. | 0 | 18 | 0 | 18 | 2 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.0 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2025 | Mar 30, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
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