BUILD 3: Bosentan Use in Interstitial Lung Disease

This study has been completed.
Information provided by (Responsible Party):
Actelion Identifier:
First received: October 20, 2006
Last updated: September 9, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Bosentan
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • Time to Occurrence of Disease Worsening or Death up to End of Study. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).

Enrollment: 616
Study Start Date: February 2007
Study Completion Date: July 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: 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)
Other Names:
  • Ro 47-0203
  • ACT-050088
Placebo Comparator: Placebo
Subjects receive placebo matching the bosentan treatment regimen
Drug: Placebo
Placebo matching bosentan 62.5 mg tablets and 125 mg tablets


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00391443

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Sponsors and Collaborators
Study Director: Isabelle Leconte Actelion
  More Information

No publications provided by Actelion

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Actelion Identifier: NCT00391443     History of Changes
Other Study ID Numbers: AC-052-321
Study First Received: October 20, 2006
Results First Received: April 25, 2012
Last Updated: September 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease

Additional relevant MeSH terms:
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Pulmonary Fibrosis
Lung Diseases
Pathologic Processes
Respiratory Tract Diseases
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 30, 2015