Idiopathic pulmonary fibrosis Respiratory Other interstitial pulmonary diseases with fibrosis
Conditions
Interventions
The patients are not assigned to the treatment by the protocol but clinical practice and following the SmPC and clinical practice for dosing in both arms.
When a patient goes to the h
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants diagnosed with idiopathic pulmonary fibrosis 2. Participants in whom their treating physician has decided, in partnership with them, to prescribe pirfenidone in accordance with the approved labelling 3. Written informed consent provided
Exclusion criteria
Exclusion criteria: 1. Concurrent participation in a clinical trial 2. Participants unable to give consent as per investigator criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactClinical Trials
Outcome results
None listed