Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
The purpose of the study was to assess the clinical outcome of patients with a mild to moderate IPF after a one-year therapy with Esbriet® (Pirfenidone).
Interventions
DRUGPirfenidone
This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.
Sponsors
InterMune Deutschland GmbH
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Adult patients with confident diagnosis of mild to moderate IPF, who had previously not yet been treated with Pirfenidone
Exclusion criteria
Hypersensitivity to the active substance or one of the other excipients of Pirfenidone Concomitant use of Fluvoxamin Severe hepatic impairment or end stage liver disease Severe renal impairment (Creatinine-Clearance \<30 ml/min) or end stage renal disease requiring dialysis Simultaneous participation in interventional studies Previously treated with Pirfenidone for longer than 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Categorical Decrease Of The Vital Capacity And Forced Volume Capacity (>= 5 % Respectively 10% Compared To The Previous Examination Findings) Under Treatment | -3 to 8 months before inclusion, appointment 0, and 3, 6, 9 and 12 months after appointment |
| Categorical Decrease of the 6-Minute Walking Distance (>= 50 Metres Compared to the Previous Examination Findings) Under Treatment | Appointment 0, and 3, 6, 9 and 12 months after appointment 0 |
| Disease Progression | Appointment 0, and 3, 6, 9 and 12 months after appointment 0 |
Secondary
| Measure | Time frame |
|---|---|
| Cases Of Death (All, Idiopathic Pulmonary Fibrosis Associated) | Up to 12 months |
| Proportion of the Participants, who After the 3 Week Titration Phase Receive the Full Maintenance Dosage Of Pirfenidone | 3, 6, 9 and 12 months after appointment 0 |
| Dosage of Pirfenidone | Up to 12 months |
| Progression of the LCQ (Leicester Cough Questionnaire) | Appointment 0, and 3, 6, 9 and 12 months after appointment 0 |
| Reasons for the Dosage Change | Up to 12 months |
| Reasons for the Beginning, Change or Discontinuation of a Treatment of Comorbidities of Pirfenidone Associated Adverse Drug Reactions | Up to 12 months |
| Number of Participants With at Least one Adverse Drug Reaction Under the Therapy With Pirfenidone | Up to 12 months |
| Proportion of the Participants who Change the Dosage Of Pirfenidone | Up to 12 months |
| Progression of the SOBQ (Shortness of Breath Questionnaire) | Appointment 0, and 3, 6, 9 and 12 months after appointment 0 |
| Proportion of the Participants With Exacerbations | Appointment 0, and 3, 6, 9 and 12 months after appointment 0 |
Countries
Germany
Outcome results
None listed