BUILD 3: Bosentan Use in Interstitial Lung Disease

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Bosentan

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.