Phase 3
N=616
BUILD 3: Bosentan Use in Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00391443 ↗Enrolled (actual)
616
Serious AEs
33.0%
Results posted
May 2012
Primary outcome: Primary: Time to Occurrence of Disease Worsening or Death up to End of Study. — 10; 18; 22; 40 participants with event — p=0.2110
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bosentan (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Actelion
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Occurrence of Disease Worsening or Death up to End of Study. |
10; 18; 22; 40; 43; 74 | 0.2110 |
| SECONDARY Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year. |
23.9; 19.9 | 0.2542 |
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.
Eligibility 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 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 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 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.
Data sourced from ClinicalTrials.gov (NCT00391443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.