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

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Pirfenidone

• Registration Number: NCT02622477
• Lead Sponsor: Hoffmann-La Roche

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-04
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-26
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with idiopathic pulmonary fibrosis	Pirfenidone	Participants with idiopathic pulmonary fibrosis receiving Pirfenidone will be observed for treatment responses.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Number of Participants With at Least one Adverse Drug Reaction Under the Therapy With Pirfenidone	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

Trial Locations

Locations (17)

Praxis Dr. med. Wilhelm Ammenwerth; 🇩🇪 Bochum, Germany

Universitätsklinikum Freiburg, Abteilung Pneumologie; 🇩🇪 Freiburg, Germany

Kliniken der Stadt Köln gGmbH Krankenhaus Merheim; 🇩🇪 Köln, Germany

Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda; 🇩🇪 Fulda, Germany

Thoraxzentrum, Abt. Pneumologie; 🇩🇪 Münnerstadt, Germany

Praxis Dr. med. Matthias Waltert; 🇩🇪 Muenster, Germany

Evang. Lungenklinik Berlin Klinik für Pneumologie; 🇩🇪 Berlin, Germany

Fachkrankenhaus Coswig GmbH; 🇩🇪 Coswig, Germany

Klinikum Werra-Meißner GmbH; 🇩🇪 Eschwege, Germany

Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie; 🇩🇪 Magdeburg, Germany

Facharztzentrum üBAG; 🇩🇪 Sonneberg, Germany

Dr. med. Martin Hoster, Dr. Hans-G. Lange von Stocmeier, Michael Behn und w.; 🇩🇪 Bochum, Germany

Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie; 🇩🇪 Essen, Germany

Augusta Kranken-Anstalt gGmbH; 🇩🇪 Bochum, Germany

Praxis Dr. med. Mathias Rolke und Dr. med. Peter Rückert; 🇩🇪 Aschaffenburg, Germany

Ev. Krankenhaus Göttingen-Weende E.V.; 🇩🇪 Göttingen, Germany

Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II; 🇩🇪 Halle, Germany