BUILD 3: Bosentan Use in Interstitial Lung Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: Ro 47-0203, ACT-050088

Placebo

Drug

Placebo matching bosentan 62.5 mg tablets and 125 mg tablets

Primary outcomes

Time to Occurrence of Disease Worsening or Death up to End of Study.

Time frame: 36 months

Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).

Secondary outcomes

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

Time frame: 12 months

Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study 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.

Acronym: BUILD 3

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Oct 24, 2006
Registry last updated: Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed