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 - BUILD 3

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 390

Inclusion Criteria

Signed informed consent. Male or female patients 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 .
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Interstitial lung disease due to conditions other than IPF. Presence of extensive honeycomb HC on Baseline high-resolution computed tomography HRCT scan. The patient is not allowed in BUILD 3 if HC involves more than 5 of the parenchyma in 3 or more of the 6 zones i.e., right and left lung, viewed at the levels of tracheal carina, inferior pulmonary veins, and 1 cm above the dome of the diaphragm , whether the involvement is unilateral or bilateral. Severe concomitant illness limiting life expectancy 1 year . Severe restrictive lung disease forced vital capacity FVC 50 predicted, or FVC 1.2 liter. Diffusing capacity of the lung for carbon monoxide DLCO 30 predicted. Residual volume 120 predicted. Obstructive lung disease forced expiratory volume in 1 second FEV1 /FVC 0.65. 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 e.g., pulmonary function tests . 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 ULN . Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C. Serum creatinine 8805; 2.5 mg/dl 221 mmol/l 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 including pirfenidone, D-penicillamine, colchicine, TNFa blocker, imatinib, interferon g, cyclophosphamide, azathioprine, -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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials