BUILD 3: Bosentan Use in Interstitial Lung Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00391443
• Date of registration: 20/10/2006
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: BUILD 3: Bosentan Use in Interstitial Lung Disease BUILD 3
• Scientific 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.
• Date of first enrolment: February 2007
• Target sample size: 616
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00391443
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Denmark, Former Serbia and Montenegro, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Serbia, Slovakia, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Isabelle Leconte
• Affiliation: Actelion

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Bosentan

Drug: Placebo

Primary Outcome(s)

Time to Occurrence of Disease Worsening or Death up to End of Study. [Time Frame: 36 months]

Secondary Outcome(s)

Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year. [Time Frame: 12 months]

Secondary ID(s)

AC-052-321

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/05/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00391443