Learn about Research & Clinical Trials

A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Study Purpose

The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
  • - Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • - Women of childbearing potential (WOCBP)1 must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration.
A list of contraception methods meeting these criteria is provided in the patient information.

Exclusion Criteria:

  • - Any disease that may put the patient at risk when participating in this trial.
Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator's benefit-risk assessment remains favourable.
  • - Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  • - Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
  • - Previous enrolment in this trial.
Further exclusion criteria apply.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03820726
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lung Diseases, Interstitial
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: All subjects

Interventions

Drug: - Nintedanib

Bid

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Completed

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

University of California Los Angeles, Los Angeles, California

Status

Active, not recruiting

Address

University of California Los Angeles

Los Angeles, California, 90095

University of California Davis, Sacramento, California

Status

Completed

Address

University of California Davis

Sacramento, California, 95817

National Jewish Health, Denver, Colorado

Status

Active, not recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Yale University School of Medicine, New Haven, Connecticut

Status

Active, not recruiting

Address

Yale University School of Medicine

New Haven, Connecticut, 06510

Pulmonary and Sleep of Tampa Bay, Brandon, Florida

Status

Active, not recruiting

Address

Pulmonary and Sleep of Tampa Bay

Brandon, Florida, 33511

Jacksonville, Florida

Status

Active, not recruiting

Address

University of Florida College of Medicine

Jacksonville, Florida, 32209

Emory University, Atlanta, Georgia

Status

Completed

Address

Emory University

Atlanta, Georgia, 30322

University of Chicago, Chicago, Illinois

Status

Completed

Address

University of Chicago

Chicago, Illinois, 60637

Loyola University Medical Center, Maywood, Illinois

Status

Completed

Address

Loyola University Medical Center

Maywood, Illinois, 60153

University of Kansas Medical Center, Kansas City, Kansas

Status

Completed

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Johns Hopkins Hospital, Baltimore, Maryland

Status

Active, not recruiting

Address

Johns Hopkins Hospital

Baltimore, Maryland, 21224

Towson, Maryland

Status

Completed

Address

Pulmonary and Critical Care Associates of Baltimore

Towson, Maryland, 21286

Brigham and Women's Hospital, Boston, Massachusetts

Status

Active, not recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Active, not recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Henry Ford Health System, Detroit, Michigan

Status

Completed

Address

Henry Ford Health System

Detroit, Michigan, 48202

Mayo Clinic, Rochester, Rochester, Minnesota

Status

Completed

Address

Mayo Clinic, Rochester

Rochester, Minnesota, 55905

The Lung Research Center, LLC, Chesterfield, Missouri

Status

Completed

Address

The Lung Research Center, LLC

Chesterfield, Missouri, 63017

Creighton University, Omaha, Nebraska

Status

Completed

Address

Creighton University

Omaha, Nebraska, 68124

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Active, not recruiting

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Completed

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

New York, New York

Status

Active, not recruiting

Address

Columbia University Medical Center-New York Presbyterian Hospital

New York, New York, 10032

New York, New York

Status

Completed

Address

NewYork-Presbyterian/Weill Cornell Medical Center

New York, New York, 10065

Duke University Medical Center, Durham, North Carolina

Status

Active, not recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

The Oregon Clinic, Portland, Oregon

Status

Active, not recruiting

Address

The Oregon Clinic

Portland, Oregon, 97220

Hershey, Pennsylvania

Status

Completed

Address

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Completed

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Baylor University Medical Center, Dallas, Texas

Status

Completed

Address

Baylor University Medical Center

Dallas, Texas, 75246

Dallas, Texas

Status

Active, not recruiting

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Diagnostics Research Group, San Antonio, Texas

Status

Completed

Address

Diagnostics Research Group

San Antonio, Texas, 78229

Medical Arts and Research Center (MARC), San Antonio, Texas

Status

Completed

Address

Medical Arts and Research Center (MARC)

San Antonio, Texas, 78229

Salt Lake City, Utah

Status

Completed

Address

University of Utah Health Sciences Center

Salt Lake City, Utah, 84108

Inova Fairfax Medical Campus, Falls Church, Virginia

Status

Active, not recruiting

Address

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042

International Sites

Centro Dr. Lazaro Langer S.R.L, Alberdi Sur, Argentina

Status

Active, not recruiting

Address

Centro Dr. Lazaro Langer S.R.L

Alberdi Sur, , X5003DCE

C.a.b.a, Argentina

Status

Active, not recruiting

Address

Centro de Investigaciones Metabólicas (CINME)

C.a.b.a, , 1056

Florida, Argentina

Status

Active, not recruiting

Address

CEMER-Centro Medico De Enfermedades Respiratorias

Florida, , B1602DQD

INSARES, Mendoza, Argentina

Status

Active, not recruiting

Address

INSARES

Mendoza, , M5500CCG

Rosario, Argentina

Status

Active, not recruiting

Address

Instituto Médico de la Fundación Estudios Clínicos

Rosario, , S2000DEJ

ULB Hopital Erasme, Bruxelles, Belgium

Status

Completed

Address

ULB Hopital Erasme

Bruxelles, , 1070

UZ Leuven, Leuven, Belgium

Status

Active, not recruiting

Address

UZ Leuven

Leuven, , 3000

Liège, Belgium

Status

Active, not recruiting

Address

Centre Hospitalier Universitaire de Liège

Liège, , 4000

Yvoir - UNIV UCL de Mont-Godinne, Yvoir, Belgium

Status

Active, not recruiting

Address

Yvoir - UNIV UCL de Mont-Godinne

Yvoir, , 5530

Winnipeg Clinic, Winnipeg, Manitoba, Canada

Status

Completed

Address

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2

St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada

Status

Active, not recruiting

Address

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6

Toronto General Hospital, Toronto, Ontario, Canada

Status

Active, not recruiting

Address

Toronto General Hospital

Toronto, Ontario, M5G 2N2

CHUS Fleurimont, Sherbrooke, Quebec, Canada

Status

Active, not recruiting

Address

CHUS Fleurimont

Sherbrooke, Quebec, J1H 5N4

Concepción, Chile

Status

Active, not recruiting

Address

Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

Concepción, , 4070038

Instituto Nacional del Tórax, Providencia, Santiago De Chile, Chile

Status

Active, not recruiting

Address

Instituto Nacional del Tórax

Providencia, Santiago De Chile, , 7500691

Centro de Investigación del Maule, Talca, Chile

Status

Active, not recruiting

Address

Centro de Investigación del Maule

Talca, , 3465586

Peking Union Medical College Hospital, Beijing, China

Status

Active, not recruiting

Address

Peking Union Medical College Hospital

Beijing, , 100730

Nanjing Drum Tower Hospital, Nanjing, China

Status

Active, not recruiting

Address

Nanjing Drum Tower Hospital

Nanjing, , 210008

Shenyang, China

Status

Active, not recruiting

Address

The First Hospital of Chinese Medical University

Shenyang, , 110001

HOP Avicenne, Bobigny, France

Status

Active, not recruiting

Address

HOP Avicenne

Bobigny, , 93009

HOP Louis Pradel, Bron, France

Status

Active, not recruiting

Address

HOP Louis Pradel

Bron, , 69677

HOP Côte de Nacre, Caen, France

Status

Active, not recruiting

Address

HOP Côte de Nacre

Caen, , 14033

CHRU Lille, Lille, France

Status

Active, not recruiting

Address

CHRU Lille

Lille, , 59037

HOP Nord, Marseille, France

Status

Active, not recruiting

Address

HOP Nord

Marseille, , 13915

HOP Arnaud de Villeneuve, Montpellier, France

Status

Active, not recruiting

Address

HOP Arnaud de Villeneuve

Montpellier, , 34295

HOP Pasteur, Nice, France

Status

Completed

Address

HOP Pasteur

Nice, , 06001

HOP Bichat, Paris, France

Status

Active, not recruiting

Address

HOP Bichat

Paris, , 75018

HOP Maison Blanche, Reims, France

Status

Active, not recruiting

Address

HOP Maison Blanche

Reims, , 51092

HOP Pontchaillou, Rennes, France

Status

Active, not recruiting

Address

HOP Pontchaillou

Rennes, , 35033

HOP Civil, Strasbourg, France

Status

Completed

Address

HOP Civil

Strasbourg, , 67091

HOP Bretonneau, Tours, France

Status

Active, not recruiting

Address

HOP Bretonneau

Tours, , 37044

Universitätsklinikum Bonn AöR, Bonn, Germany

Status

Completed

Address

Universitätsklinikum Bonn AöR

Bonn, , 53105

Fachkrankenhaus Coswig GmbH, Coswig, Germany

Status

Active, not recruiting

Address

Fachkrankenhaus Coswig GmbH

Coswig, , 01640

Klinik Donaustauf, Donaustauf, Germany

Status

Completed

Address

Klinik Donaustauf

Donaustauf, , 93093

Essen, Germany

Status

Completed

Address

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, , 45239

Medizinische Hochschule Hannover, Hannover, Germany

Status

Completed

Address

Medizinische Hochschule Hannover

Hannover, , 30625

Heidelberg, Germany

Status

Completed

Address

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, , 69126

Petrus-Krankenhaus, Wuppertal, Germany

Status

Completed

Address

Petrus-Krankenhaus

Wuppertal, , 42283

A.O.U. Policlinico Vittorio Emanuele, Catania, Italy

Status

Active, not recruiting

Address

A.O.U. Policlinico Vittorio Emanuele

Catania, , 95124

FORLì, Italy

Status

Active, not recruiting

Address

Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

FORLì, , 47121

Modena, Italy

Status

Active, not recruiting

Address

Azienda Ospedaliera Policlinico di Modena

Modena, , 41100

A.O. San Gerardo di Monza, Monza, Italy

Status

Active, not recruiting

Address

A.O. San Gerardo di Monza

Monza, , 20052

Policlinico Gemelli, Roma, Italy

Status

Active, not recruiting

Address

Policlinico Gemelli

Roma, , 00168

Siena, Italy

Status

Active, not recruiting

Address

A.O.U. Senese Policlinico Santa Maria alle Scotte

Siena, , 53100

Tosei General Hospital, Aichi, Seto, Japan

Status

Completed

Address

Tosei General Hospital

Aichi, Seto, , 489-8642

Kurume University Hospital, Fukuoka, Kurume, Japan

Status

Completed

Address

Kurume University Hospital

Fukuoka, Kurume, , 830-0011

Sapporo Medical University Hospital, Hokkaido, Sapporo, Japan

Status

Completed

Address

Sapporo Medical University Hospital

Hokkaido, Sapporo, , 060-8543

Hyogo, Himeji, Japan

Status

Completed

Address

National Hospital Organization Himeji Medical Center

Hyogo, Himeji, , 670-8520

Hyogo, Kobe, Japan

Status

Completed

Address

Kobe City Medical Center General Hospital

Hyogo, Kobe, , 650-0047

Ibarakihigashi National Hospial, Ibaraki, Naka-gun, Japan

Status

Completed

Address

Ibarakihigashi National Hospial

Ibaraki, Naka-gun, , 319-1113

Kanagawa, Yokohama, Japan

Status

Completed

Address

Kanagawa Cardiovascular and Respiratory Center

Kanagawa, Yokohama, , 236-0051

Saiseikai Kumamoto Hospital, Kumamoto, Kumamoto, Japan

Status

Completed

Address

Saiseikai Kumamoto Hospital

Kumamoto, Kumamoto, , 861-4193

Tohoku University Hospital, Miyagi, Sendai, Japan

Status

Completed

Address

Tohoku University Hospital

Miyagi, Sendai, , 980-8574

Osaka, Sakai, Japan

Status

Completed

Address

National Hospital Organization Kinki-Chuo Chest Medical Center

Osaka, Sakai, , 591-8555

Osaka Medical College Hospital, Osaka, Takatsuki, Japan

Status

Completed

Address

Osaka Medical College Hospital

Osaka, Takatsuki, , 569-8686

Hamamatsu University Hospital, Shizuoka, Hamamatsu, Japan

Status

Completed

Address

Hamamatsu University Hospital

Shizuoka, Hamamatsu, , 431-3192

Tokushima University Hospital, Tokushima, Tokushima, Japan

Status

Completed

Address

Tokushima University Hospital

Tokushima, Tokushima, , 770-8503

Tokyo Medical and Dental University, Tokyo, Bunkyo-ku, Japan

Status

Completed

Address

Tokyo Medical and Dental University

Tokyo, Bunkyo-ku, , 113-8519

Toranomon Hospital, Tokyo, Minato-ku, Japan

Status

Completed

Address

Toranomon Hospital

Tokyo, Minato-ku, , 105-8470

JR Tokyo General Hospital, Tokyo, Shibuya-ku, Japan

Status

Completed

Address

JR Tokyo General Hospital

Tokyo, Shibuya-ku, , 151-8528

Tokyo, Shinjuku-ku, Japan

Status

Completed

Address

Center Hospital of the National Center for Global Health and Medicine

Tokyo, Shinjuku-ku, , 162-8655

Bucheon, Korea, Republic of

Status

Active, not recruiting

Address

The Catholic University of Korea, Bucheon St.Mary's Hospital

Bucheon, , 14647

Seongnam, Korea, Republic of

Status

Active, not recruiting

Address

Seoul National University Bundang Hospital

Seongnam, , 13620

Asan Medical Center, Seoul, Korea, Republic of

Status

Active, not recruiting

Address

Asan Medical Center

Seoul, , 05505

University Clinical Center, Gdansk, Gdansk, Poland

Status

Active, not recruiting

Address

University Clinical Center, Gdansk

Gdansk, , 80-214

Katowice, Poland

Status

Active, not recruiting

Address

Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.

Katowice, , 40-752

Lodz, Poland

Status

Active, not recruiting

Address

Norbert Barlicki University Clinical Hospital No.1, Lodz

Lodz, , 90-153

Warszawa, Poland

Status

Active, not recruiting

Address

Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa

Warszawa, , 01-138

Zabrze, Poland

Status

Active, not recruiting

Address

Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA

Zabrze, , 41-803

Res.Inst.-Compl.Iss.Cardi.Dis., Kemerovo, Russian Federation

Status

Active, not recruiting

Address

Res.Inst.-Compl.Iss.Cardi.Dis.

Kemerovo, , 650002

Moscow, Russian Federation

Status

Active, not recruiting

Address

Central Scientific Research Insitute of Tuberculosis

Moscow, , 107564

Moscow, Russian Federation

Status

Active, not recruiting

Address

Moscow 1st State Med.Univ.n.a.I.M.Sechenov

Moscow, , 119992

St. Petersburg, Russian Federation

Status

Active, not recruiting

Address

1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.

St. Petersburg, , 197022

Yaroslavl, Russian Federation

Status

Active, not recruiting

Address

Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl

Yaroslavl, , 150003

Hospital Santa Creu i Sant Pau, Barcelona, Spain

Status

Active, not recruiting

Address

Hospital Santa Creu i Sant Pau

Barcelona, , 08026

Hospital de Galdakao, Galdakao, Spain

Status

Active, not recruiting

Address

Hospital de Galdakao

Galdakao, , 48960

Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain

Status

Recruiting

Address

Hospital de Bellvitge

L'Hospitalet de Llobregat, , 08907

Site Contact

María Molina-Molina

mariamolinamolina@hotmail.com

+34932607089

Hospital La Princesa, Madrid, Spain

Status

Active, not recruiting

Address

Hospital La Princesa

Madrid, , 28006

Hospital Central de Asturias, Oviedo, Spain

Status

Active, not recruiting

Address

Hospital Central de Asturias

Oviedo, , 33011

Hospital Son Espases, Palma de Mallorca, Spain

Status

Completed

Address

Hospital Son Espases

Palma de Mallorca, , 07120

Hospital de Canarias, San Cristóbal de La Laguna, Spain

Status

Completed

Address

Hospital de Canarias

San Cristóbal de La Laguna, , 38320

Hospital Virgen del Rocío, Sevilla, Spain

Status

Active, not recruiting

Address

Hospital Virgen del Rocío

Sevilla, , 41013

Royal Infirmary of Edinburgh, Edinburgh, United Kingdom

Status

Active, not recruiting

Address

Royal Infirmary of Edinburgh

Edinburgh, , EH16 4SA

St James's University Hospital, Leeds, United Kingdom

Status

Active, not recruiting

Address

St James's University Hospital

Leeds, , LS9 7TF

Royal Brompton Hospital, London, United Kingdom

Status

Active, not recruiting

Address

Royal Brompton Hospital

London, , SW3 6NP

Wythenshawe Hospital, Manchester, United Kingdom

Status

Active, not recruiting

Address

Wythenshawe Hospital

Manchester, , M23 9LT

University Hospital Llandough, Penarth, United Kingdom

Status

Completed

Address

University Hospital Llandough

Penarth, , CF64 2XX

Royal Stoke University Hospital, Stoke-on-Trent, United Kingdom

Status

Active, not recruiting

Address

Royal Stoke University Hospital

Stoke-on-Trent, , ST4 6QG