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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622477
• Other study ID #: ML30016
• Status: Completed
• Phase: N/A
• First received: December 2, 2015
• Last updated: February 26, 2017
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Pirfenidone
This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	InterMune Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Disease Progression		Appointment 0, and 3, 6, 9 and 12 months after appointment 0
Secondary	Progression of the LCQ (Leicester Cough Questionnaire)		Appointment 0, and 3, 6, 9 and 12 months after appointment 0
Secondary	Progression of the SOBQ (Shortness of Breath Questionnaire)		Appointment 0, and 3, 6, 9 and 12 months after appointment 0
Secondary	Proportion of the Participants With Exacerbations		Appointment 0, and 3, 6, 9 and 12 months after appointment 0
Secondary	Cases Of Death (All, Idiopathic Pulmonary Fibrosis Associated)		Up to 12 months
Secondary	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
Secondary	Dosage of Pirfenidone		Up to 12 months
Secondary	Proportion of the Participants who Change the Dosage Of Pirfenidone		Up to 12 months
Secondary	Reasons for the Dosage Change		Up to 12 months
Secondary	Reasons for the Beginning, Change or Discontinuation of a Treatment of Comorbidities of Pirfenidone Associated Adverse Drug Reactions		Up to 12 months
Secondary	Number of Participants With at Least one Adverse Drug Reaction Under the Therapy With Pirfenidone		Up to 12 months