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.

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Time to occurrence of disease worsening or death up to End of Study.

Secondary Outcome Measures:

• Proportion of patients who experienced either disease worsening or death at 1 year.

Study Start

November 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above

Genders Eligible for Study: Both

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 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 (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 NYHA class III/IV or known left ventricular ejection fraction <25%.
• ALT/SGPT and/or 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.

Total Enrolment

390

Contact Details

Prince Charles Hospital – Lung Transplant, Thoraic Dept., Chermside, Queensland, 4032, Australia; Recruiting

• Peter Hopkins, MD: (07) 3139 4000; peter.hopkins@health.qld.gov.au

Royal Adelaide Hospital-Respiratory Clinical Trials Unit, Adelaide, South Australia, 5000, Australia; Recruiting

• Paul Reynolds, Prof: (08) 8222 4244

Royal Perth Hoapital – Advanced Lung Disease Unit, Perth, Western Australia, 6000, Australia; Recruiting

• Dan Chambers, Dr: (08) 9224 8793

St. Vincent’s Public Hospital, Lung Transplantation & Respiratory Medicine, Perth, Western Australia, 6000, Australia; Recruiting

• Alan Glanville, Prof: (02) 8382 2175; aglanville@stvincents.com.au