Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment
- Registration Number
- NCT02788474
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Identifying biomarkers to predict the clinical course and benefits of therapy early in the course of the disease remains one of the most urgent and relevant challenges to improve overall patient management, to prevent treatment delay or overtreatment. This study is conducted to examine the effect of nintedanib treatment on change in biomarkers indicative of extracellular matrix turnover which have been shown recently to correlate with disease progression. This study further aims to confirm the association of biomarker course during the first three months of treatment and disease progression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 347
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - nintedanib nintedanib -
- Primary Outcome Measures
Name Time Method The Rate of Change (Slope) in Blood C-reactive Protein Degraded by Matrix Metalloproteinase-1/8 (CRPM) From Baseline to Week 12. baseline and 12 weeks The rate of change (slope) in blood C-reactive protein degraded by matrix metalloproteinase-1/8 (CRPM) from baseline to week 12 is presented. The mean presented is the adjusted rate based on a random coefficient regression (CRPM log 10 transformed) with fixed effects for gender, age, height and random effect of patient specific intercept and time.
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Disease Progression as Defined by Absolute Forced Vital Capacity (FVC) Decline >=10% or Death Until Week 52 52 weeks For this endpoint, disease progression was defined by absolute FVC (percentage of predicted) decline ≥10% or death up to Week 52 based on in-clinic supervised spirometry.
This is a key secondary endpoint of the trial. This outcome measure is "percentage of patients with disease progression" and CRPM is included in the various models as a factor/covariate, and that this outcome measure, the percentage of progressors are displayed under "Measured values"The Rate of Change in Blood Collagen 1 Degraded by Matrix Metalloproteinase-2/9/13 (C1M) From Baseline to Week 12 baseline and 12 weeks The rate of change in blood Collagen 1 degraded by matrix metalloproteinase-2/9/13 (C1M) from baseline to week 12 is presented.
The mean presented is the adjusted rate based on a random coefficient regression (C1M (negative reciprocal root transformation)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.The Rate of Change in Blood Collagen 3 Degraded by Matrix Metalloproteinase-9 (C3M) From Baseline to Week 12 baseline and 12 weeks The rate of change in blood Collagen 3 degraded by matrix metalloproteinase-9 (C3M) from baseline to week 12 is presented.
The mean presented is the adjusted rate based on a random coefficient regression (C3M- log 10 transformation) with fixed effects for gender, age, height and random effect of patient specific intercept and time.
Trial Locations
- Locations (86)
University Hospital Plzen, Plzen-Bory
🇨🇿Plzen, Czechia
Edegem - UNIV UZ Antwerpen
🇧🇪Edegem, Belgium
Kindai University Hospital
🇯🇵Osaka, Osakasayama, Japan
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium
Pulmonology Institute of Veszprem County, Farkasgyepu
🇭🇺Farkasgyepu, Hungary
Global Health and Medicine Ctr
🇯🇵Tokyo, Shinjuku-ku, Japan
Semmelweis University
🇭🇺Budapest, Hungary
Yvoir - UNIV UCL de Mont-Godinne
🇧🇪Yvoir, Belgium
Ibarakihigashi National Hospial
🇯🇵Ibaraki, Naka-gun, Japan
Non-pub.Health Care NZOZ Profilaktyka W. Pierzchala,Katowice
🇵🇱Katowice, Poland
John Paul II Cracovian Hosp
🇵🇱Krakow, Poland
UZ Leuven
🇧🇪Leuven, Belgium
Tosei General Hospital
🇯🇵Aichi, Seto, Japan
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Kanagawa, Yokohama, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
🇯🇵Osaka, Sakai, Japan
Our Doctor Clinical Trial Center, Department in Bydgoszcz
🇵🇱Bydgoszcz, Poland
Univ. Hospital in Krakow,Pulmonology Clinical Dept
🇵🇱Krakow, Poland
Practice of Internists "Nasz Lekarz", Torun
🇵🇱Torun, Poland
Toho University Omori Medical Center
🇯🇵Tokyo, Ota-ku, Japan
OYS, sisätautien klinikka
🇫🇮Oulu, Finland
Nippon Medical School Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
KYS, Keuhkosairauksien
🇫🇮Kuopio, Finland
St. Francis Medical Institute
🇺🇸Clearwater, Florida, United States
University Hospital Na Bulovce, Prague
🇨🇿Praha, Czechia
Clinical Research Solutions
🇺🇸Dayton, Ohio, United States
Pulmonary Associates of Richmond, Inc.
🇺🇸Richmond, Virginia, United States
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Masaryk Hospital, Usti nad Labem
🇨🇿Usti nad Labem, Czechia
ULB Hopital Erasme
🇧🇪Bruxelles, Belgium
Thomayer Hospital
🇨🇿Praha 4, Czechia
University Hospital Olomouc
🇨🇿Olomouc, Czechia
HYKS Keuhkosairauksien
🇫🇮Helsinki, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Helios Klinikum Emil von Behring
🇩🇪Berlin, Germany
BAZ County Central Hospital and University Teaching Hospital
🇭🇺Miskolc, Hungary
CIMS Studienzentrum Bamberg GmbH
🇩🇪Bamberg, Germany
Csongrad County's Hosp.
🇭🇺Deszk, Hungary
HOP de la Cavale Blanche
🇫🇷Brest, France
HOP Louis Pradel
🇫🇷Bron, France
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Puerta de Hierro
🇪🇸Majadahonda (Madrid), Spain
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Tokushima University Hospital
🇯🇵Tokushima, Tokushima, Japan
Papworth Hospital
🇬🇧Cambridge, United Kingdom
Hospital La Princesa
🇪🇸Madrid, Spain
Hospital Quirónsalud Madrid
🇪🇸Pozuelo de Alarcón, Spain
CS Parc Taulí
🇪🇸Sabadell, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Dr. Peset
🇪🇸Valencia, Spain
HOP Maison Blanche
🇫🇷Reims Cedex, France
HOP Pontchaillou
🇫🇷Rennes, France
HOP Civil
🇫🇷Strasbourg, France
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Universitätsmedizin Greifswald
🇩🇪Greifswald, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Gießen, Germany
Lungenfachklinik Immenhausen
🇩🇪Immenhausen, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital de Galdakao
🇪🇸Galdakao, Spain
Royal Prince Alfred Hospital
🇦🇺Camperdown, Sydney, New South Wales, Australia
University of Florida College of Medicine
🇺🇸Jacksonville, Florida, United States
Minnesota Lung Center
🇺🇸Minneapolis, Minnesota, United States
The Lung Research Center, LLC
🇺🇸Chesterfield, Missouri, United States
Western Connecticut Medical Group
🇺🇸Danbury, Connecticut, United States
Jasper Summit Research, LLC
🇺🇸Jasper, Alabama, United States
Concord General Repatriation Hospital -Ambulatory Care Unit
🇦🇺Concord, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
TYKS, Keuhkosairauksien klinikka, Turku
🇫🇮Turku, Finland
HOP Européen G. Pompidou
🇫🇷Paris, France
HOP Bretonneau
🇫🇷Tours, France
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
🇩🇪Grosshansdorf, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Klinikum der Universität München - Campus Großhadern
🇩🇪München, Germany
Kurume University Hospital
🇯🇵Fukuoka, Kurume, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Norbert Barlicki University Clinical Hospital No.1, Lodz
🇵🇱Lodz, Poland
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital de Bellvitge
🇪🇸L'Hospitalet Llobregat (bcn), Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Southmead Hospital
🇬🇧Bristol, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom