Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00391443




Registration number
NCT00391443
Ethics application status
Date submitted
20/10/2006
Date registered
24/10/2006
Date last updated
28/09/2015

Titles & IDs
Public title
BUILD 3: Bosentan Use in Interstitial Lung Disease
Scientific 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.
Secondary ID [1] 0 0
AC-052-321
Universal Trial Number (UTN)
Trial acronym
BUILD 3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bosentan
Treatment: Drugs - Placebo

Experimental: Bosentan - 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)

Placebo comparator: Placebo - Subjects receive placebo matching the bosentan treatment regimen


Treatment: Drugs: Bosentan
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)

Treatment: Drugs: Placebo
Placebo matching bosentan 62.5 mg tablets and 125 mg tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Occurrence of Disease Worsening or Death up to End of Study.
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.
Timepoint [1] 0 0
12 months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
616
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine - Darlinghurst
Recruitment hospital [2] 0 0
Prince Charles Hospital - Lung Transplant, Thoraic Dept. - Chermside
Recruitment hospital [3] 0 0
Royal Adelaide Hospital-Respiratory Clinical Trials Unit - Adelaide
Recruitment hospital [4] 0 0
Royal Perth Hospital; Advanced Lung Disease Unit - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Vermont
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Austria
State/province [26] 0 0
Graz
Country [27] 0 0
Austria
State/province [27] 0 0
Grimmenstein
Country [28] 0 0
Austria
State/province [28] 0 0
Innsbruck
Country [29] 0 0
Austria
State/province [29] 0 0
Wien
Country [30] 0 0
Belgium
State/province [30] 0 0
Leuven
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
Newfoundland and Labrador
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Croatia
State/province [35] 0 0
Zagreb
Country [36] 0 0
Czech Republic
State/province [36] 0 0
Olomouc
Country [37] 0 0
Czech Republic
State/province [37] 0 0
Praha 4
Country [38] 0 0
Czech Republic
State/province [38] 0 0
Praha 8
Country [39] 0 0
France
State/province [39] 0 0
Bobigny
Country [40] 0 0
France
State/province [40] 0 0
Bron
Country [41] 0 0
France
State/province [41] 0 0
Grenoble
Country [42] 0 0
France
State/province [42] 0 0
Lille Cedex
Country [43] 0 0
France
State/province [43] 0 0
Montpellier
Country [44] 0 0
France
State/province [44] 0 0
Paris
Country [45] 0 0
Germany
State/province [45] 0 0
Berlin
Country [46] 0 0
Germany
State/province [46] 0 0
Coswig
Country [47] 0 0
Germany
State/province [47] 0 0
Donaustauf
Country [48] 0 0
Germany
State/province [48] 0 0
Essen
Country [49] 0 0
Germany
State/province [49] 0 0
Freiburg
Country [50] 0 0
Germany
State/province [50] 0 0
Giessen
Country [51] 0 0
Germany
State/province [51] 0 0
Heidelberg
Country [52] 0 0
Germany
State/province [52] 0 0
Immenhausen
Country [53] 0 0
Germany
State/province [53] 0 0
Löwenstein
Country [54] 0 0
Germany
State/province [54] 0 0
Munich
Country [55] 0 0
Ireland
State/province [55] 0 0
Dublin 7
Country [56] 0 0
Israel
State/province [56] 0 0
Haifa
Country [57] 0 0
Israel
State/province [57] 0 0
Jerusalem
Country [58] 0 0
Israel
State/province [58] 0 0
Petach Tikvah
Country [59] 0 0
Israel
State/province [59] 0 0
Rehovot
Country [60] 0 0
Israel
State/province [60] 0 0
Tel-Aviv
Country [61] 0 0
Israel
State/province [61] 0 0
Tel-Hashomer
Country [62] 0 0
Italy
State/province [62] 0 0
Forli
Country [63] 0 0
Italy
State/province [63] 0 0
Milan
Country [64] 0 0
Italy
State/province [64] 0 0
Orbassano (Torino)
Country [65] 0 0
Italy
State/province [65] 0 0
Padova
Country [66] 0 0
Italy
State/province [66] 0 0
Palermo
Country [67] 0 0
Italy
State/province [67] 0 0
Siena
Country [68] 0 0
Japan
State/province [68] 0 0
Aichi
Country [69] 0 0
Japan
State/province [69] 0 0
Hyogo
Country [70] 0 0
Japan
State/province [70] 0 0
Kanagawa
Country [71] 0 0
Japan
State/province [71] 0 0
Nara
Country [72] 0 0
Japan
State/province [72] 0 0
Osaka
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Incheon
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Seoul
Country [75] 0 0
Netherlands
State/province [75] 0 0
Amsterdam
Country [76] 0 0
Serbia
State/province [76] 0 0
Belgrade
Country [77] 0 0
Serbia
State/province [77] 0 0
Sremska Kamenica
Country [78] 0 0
Spain
State/province [78] 0 0
Barcelona
Country [79] 0 0
Spain
State/province [79] 0 0
Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
Valencia
Country [81] 0 0
Switzerland
State/province [81] 0 0
Basel
Country [82] 0 0
Switzerland
State/province [82] 0 0
Bern
Country [83] 0 0
Switzerland
State/province [83] 0 0
Zurich
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Aberdeen
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Bristol
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Cambridge
Country [87] 0 0
United Kingdom
State/province [87] 0 0
London
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Isabelle Leconte
Address 0 0
Actelion
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00391443