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| Name | Class |
|---|---|
| InterMune Deutschland GmbH | INDUSTRY |
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with idiopathic pulmonary fibrosis | Participants with idiopathic pulmonary fibrosis receiving Pirfenidone will be observed for treatment responses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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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
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Adult patients with diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF), who had previously not yet been treated with Pirfenidone
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Dr. med. Mathias Rolke und Dr. med. Peter Rückert | Aschaffenburg | 63739 | Germany | |||
| Evang. Lungenklinik Berlin Klinik für Pneumologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38608658 | Derived | 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. |
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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