BUILD 3: Bosentan Use in Interstitial Lung Disease

NCT00391443 | Completed Phase 3 Results

• 1 other identifier: AC-052-321
• Study Type: interventional
• Target: 616
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

BUILD 3; Idiopathic Pulmonary Fibrosis; Tracleer; Interstitial Lung Disease; bosentan; Actelion

Outcome Measures

Primary Outcomes (1)

• 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).

  36 months

Secondary Outcomes (1)

• Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year.

  12 months

Study Arms (2)

Bosentan

EXPERIMENTAL

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)

Drug: Bosentan

Placebo

PLACEBO COMPARATOR

Subjects receive placebo matching the bosentan treatment regimen

Drug: Placebo

Interventions

Bosentan DRUG

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)

Also known as: Ro 47-0203, ACT-050088

Bosentan

Placebo DRUG

Placebo matching bosentan 62.5 mg tablets and 125 mg tablets

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actelion: lead

Related Publications (1)

• 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.

  PMID: 21474646 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Isabelle Leconte,PhD -Data Science Group Leader, Director
• Organization: Actelion Pharmaceuticals Ltd

isabelle.leconte@actelion.com

+41 61 565 64 18

Study Officials

• Isabelle Leconte

  Actelion

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 24, 2006
• Study Start: February 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 4, 2025
• Results First Posted: May 25, 2012

Record last verified: 2025-01