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
1 other identifier
observational
12
1 country
17
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2014
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 2, 2015
CompletedFirst Posted
Study publicly available on registry
December 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 28, 2017
February 1, 2017
2.5 years
December 2, 2015
February 26, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (1)
Participants with idiopathic pulmonary fibrosis
Participants with idiopathic pulmonary fibrosis receiving Pirfenidone will be observed for treatment responses.
Interventions
This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.
Eligibility Criteria
Adult patients with diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF), who had previously not yet been treated with Pirfenidone
You may qualify if:
- Adult patients with confident diagnosis of mild to moderate IPF, who had previously not yet been treated with Pirfenidone
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- InterMune Deutschland GmbHcollaborator
Study Sites (17)
Praxis Dr. med. Mathias Rolke und Dr. med. Peter Rückert
Aschaffenburg, 63739, Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin, 13125, Germany
Dr. med. Martin Hoster, Dr. Hans-G. Lange von Stocmeier, Michael Behn und w.
Bochum, 44787, Germany
Praxis Dr. med. Wilhelm Ammenwerth
Bochum, 44787, Germany
Augusta Kranken-Anstalt gGmbH
Bochum, 44791, Germany
Kliniken der Stadt Köln gGmbH Krankenhaus Merheim
Cologne, 51109, Germany
Fachkrankenhaus Coswig GmbH
Coswig, 01640, Germany
Klinikum Werra-Meißner GmbH
Eschwege, 37269, Germany
Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
Essen, 45239, Germany
Universitätsklinikum Freiburg, Abteilung Pneumologie
Freiburg im Breisgau, 79106, Germany
Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda
Fulda, 36043, Germany
Ev. Krankenhaus Göttingen-Weende E.V.
Göttingen, 37075, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
Halle, 06120, Germany
Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie
Magdeburg, 39120, Germany
Thoraxzentrum, Abt. Pneumologie
Münnerstadt, Germany
Praxis Dr. med. Matthias Waltert
Münster, 48145, Germany
Facharztzentrum üBAG
Sonneberg, 96515, Germany
Related Publications (1)
Schreiber J, Schutte W, Koerber W, Seese B, Koschel D, Neuland K, Grohe C. Clinical course of mild-to-moderate idiopathic pulmonary fibrosis during therapy with pirfenidone: Results of the non-interventional study AERplus. Pneumologie. 2024 Apr;78(4):236-243. doi: 10.1055/a-2267-2074. Epub 2024 Apr 12.
PMID: 38608658DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2015
First Posted
December 4, 2015
Study Start
June 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 28, 2017
Record last verified: 2017-02