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BUILD 3: Bosentan Use in Interstitial Lung Disease (BUILD 3)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bosentan
Placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring BUILD 3, Idiopathic Pulmonary Fibrosis, Tracleer, Interstitial Lung Disease, bosentan, Actelion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent
  • Male or female aged 18 years or older (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception.)
  • Proven diagnosis of IPF according to American Thoracic Society / European Respiratory Society (ATS-ERS) statement, of <3 years, with surgical lung biopsy (SLB)

Exclusion Criteria:

  • Interstitial lung disease due to conditions other than IPF.
  • Presence of extensive honeycombing (HC) on baseline high-resolution computed tomography (HRCT) scan.
  • Severe concomitant illness limiting life expectancy (<1 year).
  • Severe restrictive lung disease.
  • Obstructive lung disease.
  • Diffusing capacity of the lung for carbon monoxide <30% predicted.
  • Residual volume > or = 120% predicted.
  • Documented sustained improvement of patient's IPF condition up to 12 months prior to randomization with or without IPF-specific therapy.
  • Recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to randomization).
  • Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements.
  • Chronic heart failure with New York Heart Association (NYHA) class III/IV or known left ventricular ejection fraction <25%.
  • Alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) > 1.5 times the upper limit of the normal ranges.
  • Moderate to severe hepatic impairment.
  • Serum creatinine > or = 2.5 mg/dl or chronic dialysis.
  • Hemoglobin concentration <75% the lower limit of the normal ranges.
  • Systolic blood pressure <85 mmHg.
  • Pregnancy or breast-feeding.
  • Current drug or alcohol dependence.
  • Chronic treatment with the following drugs prescribed for IPF (within 4 weeks of randomization):oral corticosteroids (>20 mg/day of prednisone or equivalent), immunosuppressive or cytotoxic drugs, antifibrotic drugs, chronic use of N-acetylcysteine (prescribed for IPF).
  • Oral anticoagulants other than those indicated for a venous or arterial thrombotic disease.
  • Treatment with glibenclamide (glyburide) and calcineurin inhibitors (cyclosporine A, tacrolimus) up to 1 week prior to randomization.
  • Treatment with an endothelin receptor antagonist up to 3 months prior to randomization.
  • Participation in the BUILD 1 trial.
  • Treatment with another investigational drug up to 3 months prior to randomization or planned treatment.
  • Known hypersensitivity to bosentan or any of the excipients.

Sites / Locations

  • UAB Division of Pulmonary
  • Pulmonary Associates
  • Mayo Clinic
  • USC University Hospital
  • UCLA-Division of Pulmonary & Critical Care
  • UC Davis University of California
  • UCSD Medical Center
  • UCSF-Interstitial Lung Disease Center
  • Pulmonary and Critical Care Medicine-Stanford University Medical Center
  • National Jewish Medical & Research Center
  • Yale University School of Medicine-Dept of Internal Med-Pulmonary & Critical Care
  • PAB Clinical Research
  • Emory University
  • University of Chicago - Section of Pulmonary, Dept of Medicine, Respiratory Clinical Research
  • Consultants in Pulmonary Medicine
  • Wichita Clinic, P.A.
  • Boston University School of Medicine
  • Beth Israel Deaconess Medical Center
  • University of Minnesota
  • Mayo Clinic
  • St. Luke's Medical Group, Cardio-Pulmonary Research
  • Pulmonary & Allergy Associates, P.A.
  • Mount Sinai School of Medicine
  • Highland Hospital - Pulmonary Department
  • Duke University Medical Center
  • University of Cincinnati
  • The Cleveland Clinic Foundation
  • University of Pennsylvania Medical Center
  • Temple University Hospital
  • Medical University of South Carolina
  • Vanderbilt Medical Center - IPF Center
  • University of Texas-Southwestern Dallas-Div. of Pulm & Critical Care Unit
  • Baylor College of Medicine
  • University of Utah
  • Vermont Lung Center
  • University of Virginia - Div. of Pulmonary & Critical Care
  • Inova Heart and Vascular Institute
  • University of Washington Medical Center
  • University of Wisconsin-Madison
  • St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine
  • Prince Charles Hospital - Lung Transplant, Thoraic Dept.
  • Royal Adelaide Hospital-Respiratory Clinical Trials Unit
  • Royal Perth Hospital; Advanced Lung Disease Unit
  • Medizinische Universität Graz-Klinische Abteilung für Pulmonologie
  • Landesklinikum Thermenregion Hochegg
  • Medical University of Innsbruck-Div. of Clinical & Internal Medicine
  • Medical University of Vienna and AKH-Div of Pulmonology
  • Otto-Wagner Spital Wien
  • UZ Gasthuisberg
  • Walter C. Mackenzie Health Sciences Centre-Univeristy of Alberta
  • The Health Care Corporation of St. John's-Eastern Health
  • St. Joseph's Healthcare
  • Lawson Health Research Institute
  • Toronto General Hospital-Rosedale Medical Center PFT Lab
  • Hopital Notre Dame - Centre Hospitalier de L'Universit de Montreal
  • Institut de Cardiologie et de Pneumologie de l'Universite Laval
  • University Hospital for Lung Disease "Jordanovac"
  • University Hospital Olomouc - Dept of Respiratory Disease-IP Pavlova
  • Thomayer Faculty Hospital Prague-Dept of Respiratory Disease
  • University Hospital Na Bulovce
  • Hopital Avicenne
  • Hopital Louis Pradel
  • HYLAB, Clinique du Mail
  • CHRU de Lille-Hopital Albert Calmette
  • CHU Hôpital Arnaud de Villeneuve
  • Hôpital Bichat
  • HELIOS Klinikum Emil von Behring
  • Fachkrankenhaus Coswig; Centre for Pulmonology and Thoracic Surgery
  • Klinik Donaustauf-Zentrum für Pneumologie
  • Ruhrlandklinik, Pneumologie/Allergologie
  • Medizinische Universitätsklinik, Abteilung Pneumologie
  • Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin
  • Thoraxklinik Heidelberg GmbH
  • Fachklinik fur Lungenerkrankungen
  • Klinik Löwenstein GmbH-Medizinische Klinik 1 Pneumologie-Kardiologie
  • Klinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern
  • Mater Misicordiae Hospital
  • Rambam Medical Centre-Div. for Pulmonary Disease
  • Hadassah Medical Organization: Ein Karem-Institute of Pulmonology
  • Pulmonary Istitute-Rabin Medical Centre: Beilinson Campus
  • Kaplan Medical Centre-Pulmoary Istitute
  • Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergic Diseases
  • Chaim Sheba Medical Centre
  • Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento
  • Ospedale San Giuseppe Milanocuore, Unita Operativa di Pneumologia
  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
  • Azienda Ospedaliera di Padova - Immunologia Clinica
  • Pneumologia ISMETT
  • University degli Studi Siena, Policlinico le Scotte
  • Tosei General Hospital
  • Himeji medical center
  • Kanagawa Cardiovascular Respiratory Center
  • Tenri Hospital
  • Kinki - Chuo Chest Medical Center
  • Gil Medical Centre, Gachon University
  • Seoul National University Hospital
  • Samsung Medical Centre
  • Asan Medical Center
  • SoonChunHyang University Bucheon Hospital
  • Academisch Medisch Centrum Amsterdam
  • Institut za Plucne bolest l TBC Klinickog Centra Srbije
  • Institut za Plucne bolesti Vojvodine, Sremska Kamenica
  • Hospital Vall d'Hebron-Neumologia
  • Hospital Clinic Barcelona (Pneumology Service)
  • Hospital La Princesa
  • Hospital Universitario Ramon y Cajal
  • Hospital Clinico San Carlos
  • Hospital General de Valencia
  • Hospital Universitario Dr. Peset
  • University Hospital Basel-Div of Pneumology
  • Inselspital Bern-Div of Pulmonary Medicine
  • University Hopital Zurich-Clinic for Pneumology & Lung Transplant Program
  • Aberdeen Royal Infirmary
  • Southmead Hospital
  • Papworth Hospital
  • Royal Brompton Hospital
  • NWLC, Wythenshawe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bosentan

Placebo

Arm Description

Subjects receive bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg b.i.d (if body weight > 40 kg) or bosentan 62.5 mg b.i.d. (if body weight < 40 kg)

Subjects receive placebo matching the bosentan treatment regimen

Outcomes

Primary Outcome Measures

Time to Occurrence of Disease Worsening or Death up to End of Study.
Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).

Secondary Outcome Measures

Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.
Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).

Full Information

First Posted
October 20, 2006
Last Updated
September 9, 2015
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00391443
Brief Title
BUILD 3: Bosentan Use in Interstitial Lung Disease
Acronym
BUILD 3
Official Title
Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

5. Study Description

Brief Summary
BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
BUILD 3, Idiopathic Pulmonary Fibrosis, Tracleer, Interstitial Lung Disease, bosentan, Actelion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
616 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bosentan
Arm Type
Experimental
Arm Description
Subjects receive bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg b.i.d (if body weight > 40 kg) or bosentan 62.5 mg b.i.d. (if body weight < 40 kg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects receive placebo matching the bosentan treatment regimen
Intervention Type
Drug
Intervention Name(s)
Bosentan
Other Intervention Name(s)
Ro 47-0203, ACT-050088
Intervention Description
Bosentan 62.5 mg tablets twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg tablets b.i.d (if body weight > 40 kg) or bosentan 62.5 mg tablets b.i.d. (if body weight < 40 kg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching bosentan 62.5 mg tablets and 125 mg tablets
Primary Outcome Measure Information:
Title
Time to Occurrence of Disease Worsening or Death up to End of Study.
Description
Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.
Description
Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent Male or female aged 18 years or older (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception.) Proven diagnosis of IPF according to American Thoracic Society / European Respiratory Society (ATS-ERS) statement, of <3 years, with surgical lung biopsy (SLB) Exclusion Criteria: Interstitial lung disease due to conditions other than IPF. Presence of extensive honeycombing (HC) on baseline high-resolution computed tomography (HRCT) scan. Severe concomitant illness limiting life expectancy (<1 year). Severe restrictive lung disease. Obstructive lung disease. Diffusing capacity of the lung for carbon monoxide <30% predicted. Residual volume > or = 120% predicted. Documented sustained improvement of patient's IPF condition up to 12 months prior to randomization with or without IPF-specific therapy. Recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to randomization). Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements. Chronic heart failure with New York Heart Association (NYHA) class III/IV or known left ventricular ejection fraction <25%. Alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) > 1.5 times the upper limit of the normal ranges. Moderate to severe hepatic impairment. Serum creatinine > or = 2.5 mg/dl or chronic dialysis. Hemoglobin concentration <75% the lower limit of the normal ranges. Systolic blood pressure <85 mmHg. Pregnancy or breast-feeding. Current drug or alcohol dependence. Chronic treatment with the following drugs prescribed for IPF (within 4 weeks of randomization):oral corticosteroids (>20 mg/day of prednisone or equivalent), immunosuppressive or cytotoxic drugs, antifibrotic drugs, chronic use of N-acetylcysteine (prescribed for IPF). Oral anticoagulants other than those indicated for a venous or arterial thrombotic disease. Treatment with glibenclamide (glyburide) and calcineurin inhibitors (cyclosporine A, tacrolimus) up to 1 week prior to randomization. Treatment with an endothelin receptor antagonist up to 3 months prior to randomization. Participation in the BUILD 1 trial. Treatment with another investigational drug up to 3 months prior to randomization or planned treatment. Known hypersensitivity to bosentan or any of the excipients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Leconte
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
UAB Division of Pulmonary
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pulmonary Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
USC University Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA-Division of Pulmonary & Critical Care
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Davis University of California
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSF-Interstitial Lung Disease Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Pulmonary and Critical Care Medicine-Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
National Jewish Medical & Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Yale University School of Medicine-Dept of Internal Med-Pulmonary & Critical Care
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago - Section of Pulmonary, Dept of Medicine, Respiratory Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Consultants in Pulmonary Medicine
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Wichita Clinic, P.A.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Luke's Medical Group, Cardio-Pulmonary Research
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Pulmonary & Allergy Associates, P.A.
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
Highland Hospital - Pulmonary Department
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt Medical Center - IPF Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5735
Country
United States
Facility Name
University of Texas-Southwestern Dallas-Div. of Pulm & Critical Care Unit
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Vermont Lung Center
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Facility Name
University of Virginia - Div. of Pulmonary & Critical Care
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Heart and Vascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-3240
Country
United States
Facility Name
St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Prince Charles Hospital - Lung Transplant, Thoraic Dept.
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Adelaide Hospital-Respiratory Clinical Trials Unit
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Perth Hospital; Advanced Lung Disease Unit
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Landesklinikum Thermenregion Hochegg
City
Grimmenstein
ZIP/Postal Code
2840
Country
Austria
Facility Name
Medical University of Innsbruck-Div. of Clinical & Internal Medicine
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Medical University of Vienna and AKH-Div of Pulmonology
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Otto-Wagner Spital Wien
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Walter C. Mackenzie Health Sciences Centre-Univeristy of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
The Health Care Corporation of St. John's-Eastern Health
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Toronto General Hospital-Rosedale Medical Center PFT Lab
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4X 1W4
Country
Canada
Facility Name
Hopital Notre Dame - Centre Hospitalier de L'Universit de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Institut de Cardiologie et de Pneumologie de l'Universite Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
University Hospital for Lung Disease "Jordanovac"
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Olomouc - Dept of Respiratory Disease-IP Pavlova
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Thomayer Faculty Hospital Prague-Dept of Respiratory Disease
City
Praha 4
ZIP/Postal Code
140 59
Country
Czech Republic
Facility Name
University Hospital Na Bulovce
City
Praha 8
ZIP/Postal Code
180 81
Country
Czech Republic
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Hopital Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
HYLAB, Clinique du Mail
City
Grenoble
ZIP/Postal Code
38100
Country
France
Facility Name
CHRU de Lille-Hopital Albert Calmette
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Bichat
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
HELIOS Klinikum Emil von Behring
City
Berlin
ZIP/Postal Code
D-14165
Country
Germany
Facility Name
Fachkrankenhaus Coswig; Centre for Pulmonology and Thoracic Surgery
City
Coswig
Country
Germany
Facility Name
Klinik Donaustauf-Zentrum für Pneumologie
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Ruhrlandklinik, Pneumologie/Allergologie
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Medizinische Universitätsklinik, Abteilung Pneumologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Thoraxklinik Heidelberg GmbH
City
Heidelberg
ZIP/Postal Code
01640
Country
Germany
Facility Name
Fachklinik fur Lungenerkrankungen
City
Immenhausen
Country
Germany
Facility Name
Klinik Löwenstein GmbH-Medizinische Klinik 1 Pneumologie-Kardiologie
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Klinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Mater Misicordiae Hospital
City
Dublin 7
Country
Ireland
Facility Name
Rambam Medical Centre-Div. for Pulmonary Disease
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Organization: Ein Karem-Institute of Pulmonology
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Pulmonary Istitute-Rabin Medical Centre: Beilinson Campus
City
Petach Tikvah
Country
Israel
Facility Name
Kaplan Medical Centre-Pulmoary Istitute
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergic Diseases
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Chaim Sheba Medical Centre
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento
City
Forli
ZIP/Postal Code
47100
Country
Italy
Facility Name
Ospedale San Giuseppe Milanocuore, Unita Operativa di Pneumologia
City
Milan
ZIP/Postal Code
20123
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
City
Orbassano (Torino)
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera di Padova - Immunologia Clinica
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Pneumologia ISMETT
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
University degli Studi Siena, Policlinico le Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Tosei General Hospital
City
Seto
State/Province
Aichi
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Himeji medical center
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Kanagawa Cardiovascular Respiratory Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Tenri Hospital
City
Tenri
State/Province
Nara
ZIP/Postal Code
632-8552
Country
Japan
Facility Name
Kinki - Chuo Chest Medical Center
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Gil Medical Centre, Gachon University
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Centre
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
SoonChunHyang University Bucheon Hospital
City
Seoul
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Academisch Medisch Centrum Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Institut za Plucne bolest l TBC Klinickog Centra Srbije
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institut za Plucne bolesti Vojvodine, Sremska Kamenica
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Hospital Vall d'Hebron-Neumologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic Barcelona (Pneumology Service)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital General de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
University Hospital Basel-Div of Pneumology
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital Bern-Div of Pulmonary Medicine
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
University Hopital Zurich-Clinic for Pneumology & Lung Transplant Program
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Papworth Hospital
City
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
NWLC, Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21474646
Citation
King TE Jr, Brown KK, Raghu G, du Bois RM, Lynch DA, Martinez F, Valeyre D, Leconte I, Morganti A, Roux S, Behr J. BUILD-3: a randomized, controlled trial of bosentan in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 Jul 1;184(1):92-9. doi: 10.1164/rccm.201011-1874OC. Epub 2011 Apr 7.
Results Reference
derived

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BUILD 3: Bosentan Use in Interstitial Lung Disease

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