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

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

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).

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Pirfenidone

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Germany
  • Aschaffenburg, Germany, 63739
    • Praxis Dr. med. Mathias Rolke und Dr. med. Peter Rückert
  • Berlin, Germany, 13125
    • Evang. Lungenklinik Berlin Klinik für Pneumologie
  • Bochum, Germany, 44791
    • Augusta Kranken-Anstalt gGmbH
  • Bochum, Germany, 44787
    • Dr. med. Martin Hoster, Dr. Hans-G. Lange von Stocmeier, Michael Behn und w.
  • Bochum, Germany, 44787
    • Praxis Dr. med. Wilhelm Ammenwerth
  • Coswig, Germany, 01640
    • Fachkrankenhaus Coswig GmbH
  • Eschwege, Germany, 37269
    • Klinikum Werra-Meißner GmbH
  • Essen, Germany, 45239
    • Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg, Abteilung Pneumologie
  • Fulda, Germany, 36043
    • Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda
  • Göttingen, Germany, 37075
    • Ev. Krankenhaus Göttingen-Weende E.V.
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
  • Köln, Germany, 51109
    • Kliniken der Stadt Köln gGmbH Krankenhaus Merheim
  • Magdeburg, Germany, 39120
    • Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie
  • Muenster, Germany, 48145
    • Praxis Dr. med. Matthias Waltert
  • Münnerstadt, Germany
    • Thoraxzentrum, Abt. Pneumologie
  • Sonneberg, Germany, 96515
    • Facharztzentrum üBAG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF), who had previously not yet been treated with Pirfenidone

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with idiopathic pulmonary fibrosis; Participants with idiopathic pulmonary fibrosis receiving Pirfenidone will be observed for treatment responses.	Drug: Pirfenidone; This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: InterMune Deutschland GmbH

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 4, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 26, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Pirfenidone
• Other Study ID Numbers: ML30016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided