Can a patient assistance program reduce the proportion of people with idiopathic pulmonary fibrosis (IPF) who stop taking pirfenidone?

Time in days to permanent discontinuation of pirfenidone (i.e. time on pirfenidone) in participants allocated in PAP compared with participants who continue being followed-up as per the routine standard of care (SoC) up to 27 months

1. Percentage of participants who discontinue pirfenidone within the first 6 months of treatment up to 27 months]
2. Reasons for discontinuing pirfenidone: type and severity of adverse events (AEs) related to IPF treatment, type and severity of AEs unrelated to IPF treatment, worsening symptoms, physician’ s decision, patient’s decision, any other reason from baseline up to 27 months
3. Time and number of temporary interruptions of pirfenidone when they are communicated within the study duration from baseline up to 27 months
4. Time and number of dose-adjustments of pirfenidone (i.e. dose reductions) as per SmPC from baseline up to 27 months
5. Titrated-dose and full-dose of pirfenidone measured in mg from baseline up to 27 months
6. Adherence to pirfenidone measured by Morisky-Green (MG) questionnaire and by counting returned medication every month from baseline up to 27 months
7. Factors predicting adherence to and discontinuation of pirfenidone measured by patient activation measure (PAM) questionnaire at the inclusion and final visits from baseline up to 27 months
8. The role of psycho-morbidity (symptoms of depression and anxiety) on adherence to and discontinuation of pirfenidone measured by hospital anxiety and depression scale (HADS) score from baseline up to 27 months
9. Number and reasons for hospitalizations from baseline up to 27 months
10. Percentage of participants with adverse events (AE) from baseline up to 27 months
11. Functional respiratory changes of participants measured by forced vital capacity (FVC; absolute and % of predicted value), forced expiratory volume in one second (FEV1), FEV1/FVC ratio, diffusing capacity of the lungs for carbon monoxide (DLCO, percentage of predicted value), and distance on 6-min walking test (6MWT) at baseline, visits 1 and 3 and then at every 6-month visit (up to 27 months)
12. Degree of dyspnea and fatigue after the administration of pirfenidone measured by modified Medical Research Council (mMRC) and Fatigue Assessment Scale (FAS) score, respectively, at baseline, visits 1 and 3 and then at every 6-month visit (up to 27 months)
13. Severity of cough after the administration of pirfenidone measured by Visual Analog Scale (VAS) score at baseline, visits 1 and 3 and then at every 6-month visit (up to 27 months)
14. Quality of life of participants measured by King’s Brief Interstitial Lung Disease (K-BILD) score at baseline and at last study visit
15. Satisfaction of participants with PAP measured by a 5-point Likert scale at the last study visit
16. Time-dependent impact of PAP on persistence rate of pirfenidone measured by the percentage of participants in the PAP group that remain on pirfenidone at different time-points from baseline, up to 27 months