Idiopathic Pulmonary FibrosisREPEATNCT06485635
Real-life-persistence to Antifibrotic Treatments
An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 1 site in France.
Trial summary
This study will help to better understand the persistence rate to antifibrotic (AF) treatment in real life in France and to identify potential areas for improvement by investigating the factors associated with a non-persistence rate to AF treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Nintedanib and Pirfenidone
- How many people
- 10,646 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2024to 7 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.
Who may be able to join
- All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.
Who cannot join
- No exclusion criteria will be applied.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-life-Persistence to Antifibrotic Treatments
This study will help to better understand the persistence rate to antifibrotic (AF) treatment in real life in France and to identify potential areas for improvement by investigating the factors associated with a non-persistence rate to AF treatment.
Primary objective of the study is to measure the percentage of patients still treated up to 30 months after AF treatment initiation.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Nintedanib, Pirfenidone
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
Nintedanib
PirfenidoneDrug
Pirfenidone
| Study group | Role | What they receive |
|---|---|---|
| Patients with a reimbursement of AF treatment | Not described Receives: Drug: Nintedanib; Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence to antifibrotic (AF) treatment (measured as percentage of patients still treated up to 30 months after AF treatment initiation)
Measured: up to 30 months
Secondary outcomes (10)
AF prevalence in French population
Measured: up to 5 years
AF incidence in French population
Measured: up to 4 years
Number of AF treated patients split by indication
Indications:
- Idiopathic Pulmonary Fibrosis (IPF)
- Interstitial Lung Disease associated with Systemic Sclerosis (SSc-ILD)
- Progressive Pulmonary Fibrosis (PPF)
Measured: up to 2 years
Number of patients adherent to AF treatment
In incident AF patients, percentage of days covered (PDC) will be calculated at different time point to measure the adherence to AF treatment for patients persistent to treatment at this time point.
The PDC is the ratio dividing the number of days exposed by the number of days in the period evaluated.
A PDC≥ 80% is considered as a good adherence to medication.
Measured: up to 30 months
Percentage of the target cumulative dose of treatment received by the patients
Measured: up to 30 months
Influence of factors (yes/no) associated with persistence to AF treatments
For a pre-determined list of variables (as defined in the study protocol) in incident AF patients, a multivariate time-dependant Cox model will test several covariates to check if they are associated with persistence to AF treatment.
Measured: up to 30 months
Number of patients with switch from one AF treatment to the another with no treatment stop
Measured: up to 5 years
Number of patients at site of follow-up (identified as 2 lung function tests performed in the center)
Measured: up to 5 years
Overall Survival (defined as time from index date (first reimbursement of AF treatment) to death from any cause)
Measured: up to5 years
Event-free survival
Defined as the time from index date to
- oxygenotherapy onset
- hospitalisation for respiratory exacerbations
- hospitalisation for other respiratory diseases
- ath from any cause
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start16 Oct 2024
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 10,646 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
- NCT06485635
- Sponsor's protocol ID
- 1199-0568
- Acronym
- REPEAT
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life-Persistence to Antifibrotic Treatments
- ClinicalTrials.gov ID
- NCT06485635
- Acronym / sponsor ID
- REPEAT / 1199-0568
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,646 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will help to better understand the persistence rate to antifibrotic (AF) treatment in real life in France and to identify potential areas for improvement by investigating the factors associated with a non-persistence rate to AF treatment.
Primary objective of the study is to measure the percentage of patients still treated up to 30 months after AF treatment initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a reimbursement of AF treatment | – | Drug: Nintedanib, Drug: Pirfenidone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.
Key inclusion criteria (1 listed)
- All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.
Key exclusion criteria (1 listed)
- No exclusion criteria will be applied.
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 |
|---|---|---|
| NintedanibNintedanib | Drug | Patients with a reimbursement of AF treatment |
| PirfenidonePirfenidone | Drug | Patients with a reimbursement of AF treatment |
Primary outcome
Persistence to antifibrotic (AF) treatment (measured as percentage of patients still treated up to 30 months after AF treatment initiation)
Time frame: up to 30 months
10 secondary outcomes
AF prevalence in French population
Time frame: up to 5 years
AF incidence in French population
Time frame: up to 4 years
Number of AF treated patients split by indication
Time frame: up to 2 years
Number of patients adherent to AF treatment
Time frame: up to 30 months
Percentage of the target cumulative dose of treatment received by the patients
Time frame: up to 30 months
Influence of factors (yes/no) associated with persistence to AF treatments
Time frame: up to 30 months
Number of patients with switch from one AF treatment to the another with no treatment stop
Time frame: up to 5 years
Number of patients at site of follow-up (identified as 2 lung function tests performed in the center)
Time frame: up to 5 years
Overall Survival (defined as time from index date (first reimbursement of AF treatment) to death from any cause)
Time frame: up to5 years
Event-free survival
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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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.
1 site 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, run by Boehringer Ingelheim at 1 site in France.
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 1 inclusion and 1 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Persistence to antifibrotic (AF) treatment (measured as percentage of patients still treated up to 30 months after AF treatment initiation) (time frame: up to 30 months). 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 15 Apr 2026.