Idiopathic Pulmonary FibrosisNCT06200714
A Study Based on Medical Records in Spain That Looks at Diarrhoea Control in People With Pulmonary Fibrosis Who Are Taking Nintedanib
An observational study of Idiopathic Pulmonary Fibrosis and Diarrhoea, run by Boehringer Ingelheim at 8 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Diarrhoea
- What is being tested?
- Nintedanib
- How many people
- 18 participants
- Where
- 8 sitesSpain
- Study dates
- 16 Jul 2024to 29 Apr 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical management of interstitial lung diseases (IPF) or other progressive pulmonary fibrosis (PPF) patients who experienced nintedanib-associated diarrhoea.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916
Hospital Universitario de Cruces
Bizkaia, 48903
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital de La Princesa
Madrid, 28006
Hospital Clínico San Carlos
Madrid, 28040
Hospital Álvaro Cunqueiro
Pontevedra, 36312
Hospital Clínico Universitario de Valencia
Valencia, 46010
About this study
Official title: 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
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.
- Conditions
- Idiopathic Pulmonary Fibrosis, Diarrhoea
- Being tested
- Nintedanib
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
Also called OFEV
Participants received 150 milligrams (mg) Nintedanib, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after baseline visit.
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline visit, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start16 Jul 2024
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200714
- Sponsor's protocol ID
- 1199-0545
- Status last verified
- Mar 2026
- First submitted
- 29 Dec 2023
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06200714
- Acronym / sponsor ID
- 1199-0545
- Conditions
- Idiopathic Pulmonary Fibrosis, Diarrhoea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Posted 13 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPF/PPF Participants | – | Drug: NintedanibParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical management of interstitial lung diseases (IPF) or other progressive pulmonary fibrosis (PPF) patients who experienced nintedanib-associated diarrhoea.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NintedanibAlso: OFEVParticipants received 150 milligrams (mg) Nintedanib, twice daily. | Drug | IPF/PPF Participants |
Primary outcome
Achievement of Diarrhoea Control at Week 12 Follow-up While Taking the Optimal Nintedanib Dose
Time frame: 12 weeks after baseline visit.
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.
10 secondary outcomes
Absolute Change in the Proportion of Participants Taking the Optimal Nintedanib Dose at Week 12 Follow-up
Time frame: 12 weeks after baseline visit.
Absolute Change From Baseline in BSFS Score at Week 12 Follow-up
Time frame: At baseline and at Week 12.
Absolute Change From Baseline in Number of Stools Per Day at Week 12 Follow-up
Time frame: At baseline and at Week 12.
Absolute Change From Baseline in Current Body Weight at Week 12 Follow-up
Time frame: At baseline and at Week 12.
Proportion of Participants Who Used Carob Flour for the Treatment of Nintedanib-associated Diarrhoea
Time frame: From baseline visit, up to 12 weeks.
Number of Participants Per Treatment Category for Nintedanib-associated Diarrhoea at Diarrhoea Initiation
Time frame: At baseline visit.
Number of Participants Per Treatment Category for Nintedanib-associated Diarrhoea at Week 12 Follow-up
Time frame: 12 weeks after baseline visit.
Occurrence of at Least One Nintedanib Dose Reduction From Diarrhoea Initiation to Week 12 Follow-up
Time frame: From baseline visit, up to 12 weeks.
Occurrence of Permanent Withdrawal of Nintedanib
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
Time frame: From baseline visit, up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Diarrhoea, run by Boehringer Ingelheim at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of Diarrhoea Control at Week 12 Follow-up While Taking the Optimal Nintedanib Dose (time frame: 12 weeks after baseline visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.