Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone)

Study Overview
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Brief Summary
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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).

Official Title
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Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPF

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: Pirfenidone


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with idiopathic pulmonary fibrosis<br>Participants with idiopathic pulmonary fibrosis receiving Pirfenidone will be observed for treatment responses. | Drug: Pirfenidone<br>* This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of the LCQ (Leicester Cough Questionnaire) |  | Appointment 0, and 3, 6, 9 and 12 months after appointment 0 | 
| 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 | 
| 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 | 
| Proportion of the Participants who Change the Dosage Of Pirfenidone |  | Up to 12 months | 
| 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 |