Real-life-persistence to Antifibrotic Treatments

Active, not recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Nintedanib; Drug: Pirfenidone

• Registration Number: NCT06485635
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Primary objective of the study is to measure the percentage of patients still treated up to 30 months after AF treatment initiation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-07-03
• Study Start: 2024-10-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-06-27
• Study Completion: 2025-06-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10646

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with a reimbursement of AF treatment	Nintedanib	-
Patients with a reimbursement of AF treatment	Pirfenidone	-

Primary Outcome Measures

Name	Time	Method
Persistence to antifibrotic (AF) treatment (measured as percentage of patients still treated up to 30 months after AF treatment initiation)	up to 30 months

Secondary Outcome Measures

Name	Time	Method
AF incidence in French population	up to 4 years
Number of AF treated patients split by indication	up to 2 years	Indications: * Idiopathic Pulmonary Fibrosis (IPF); * Interstitial Lung Disease associated with Systemic Sclerosis (SSc-ILD); * Progressive Pulmonary Fibrosis (PPF)
Number of patients adherent to AF treatment	up to 30 months	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.
Percentage of the target cumulative dose of treatment received by the patients	up to 30 months
Influence of factors (yes/no) associated with persistence to AF treatments	up to 30 months	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.
Number of patients at site of follow-up (identified as 2 lung function tests performed in the center)	up to 5 years
Overall Survival (defined as time from index date (first reimbursement of AF treatment) to death from any cause)	up to5 years
Event-free survival	up to 5 years	Defined as the time from index date to; * oxygenotherapy onset; * hospitalisation for respiratory exacerbations; * hospitalisation for other respiratory diseases; * ath from any cause
AF prevalence in French population	up to 5 years
Number of patients with switch from one AF treatment to the another with no treatment stop	up to 5 years

Trial Locations

Locations (1)

Clinityx; 🇫🇷 Boulogne-Billancourt, France