Clinical trial NCT02622477: Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone)
Official title: Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: InterMune Deutschland GmbH
First posted: 2015-12-04
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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).


Eligibility criteria: 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

Primary outcomes:
measure: Categorical Decrease Of The Vital Capacity And Forced Volume Capacity (>= 5 % Respectively 10% Compared To The Previous Examination Findings) Under Treatment
timeFrame: -3 to 8 months before inclusion, appointment 0, and 3, 6, 9 and 12 months after appointment
measure: Categorical Decrease of the 6-Minute Walking Distance (>= 50 Metres Compared to the Previous Examination Findings) Under Treatment
timeFrame: Appointment 0, and 3, 6, 9 and 12 months after appointment 0
measure: Disease Progression
timeFrame: Appointment 0, and 3, 6, 9 and 12 months after appointment 0
Secondary outcomes:
measure: Progression of the LCQ (Leicester Cough Questionnaire)
timeFrame: Appointment 0, and 3, 6, 9 and 12 months after appointment 0
measure: Progression of the SOBQ (Shortness of Breath Questionnaire)
timeFrame: Appointment 0, and 3, 6, 9 and 12 months after appointment 0
measure: Proportion of the Participants With Exacerbations
timeFrame: Appointment 0, and 3, 6, 9 and 12 months after appointment 0
measure: Cases Of Death (All, Idiopathic Pulmonary Fibrosis Associated)
timeFrame: Up to 12 months
measure: Proportion of the Participants, who After the 3 Week Titration Phase Receive the Full Maintenance Dosage Of Pirfenidone
timeFrame: 3, 6, 9 and 12 months after appointment 0
measure: Dosage of Pirfenidone
timeFrame: Up to 12 months
measure: Proportion of the Participants who Change the Dosage Of Pirfenidone
timeFrame: Up to 12 months
measure: Reasons for the Dosage Change
timeFrame: Up to 12 months
measure: Reasons for the Beginning, Change or Discontinuation of a Treatment of Comorbidities of Pirfenidone Associated Adverse Drug Reactions
timeFrame: Up to 12 months
measure: Number of Participants With at Least one Adverse Drug Reaction Under the Therapy With Pirfenidone
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Praxis Dr. med. Mathias Rolke und Dr. med. Peter Rückert
city: Berlin
country: Germany
facility: Evang. Lungenklinik Berlin Klinik für Pneumologie
city: Bochum
country: Germany
facility: Dr. med. Martin Hoster, Dr. Hans-G. Lange von Stocmeier, Michael Behn und w.
city: Bochum
country: Germany
facility: Praxis Dr. med. Wilhelm Ammenwerth
city: Bochum
country: Germany
facility: Augusta Kranken-Anstalt gGmbH
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig GmbH
city: Eschwege
country: Germany
facility: Klinikum Werra-Meißner GmbH
city: Essen
country: Germany
facility: Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Abteilung Pneumologie
city: Fulda
country: Germany
facility: Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda
city: Göttingen
country: Germany
facility: Ev. Krankenhaus Göttingen-Weende E.V.
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
city: Köln
country: Germany
facility: Kliniken der Stadt Köln gGmbH Krankenhaus Merheim
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie
city: Muenster
country: Germany
facility: Praxis Dr. med. Matthias Waltert
city: Münnerstadt
country: Germany
facility: Thoraxzentrum, Abt. Pneumologie
city: Sonneberg
country: Germany
facility: Facharztzentrum üBAG
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: