BUILD 3: Bosentan Use in Interstitial Lung Disease - Full Text View

Sponsored by:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00391443

Purpose

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.

Condition	Intervention	Phase
Idiopathic Pulmonary Fibrosis	Drug: placebo Drug: Bosentan	Phase III

MedlinePlus related topics: Pulmonary Fibrosis

Drug Information available for: Bosentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Actelion:

Primary Outcome Measures:

Time to occurrence of disease worsening or death up to End of Study. [ Time Frame: 18-32 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients who experienced either disease worsening or death at 1 year. [ Time Frame: 18-32 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Initial dose: 62.5 mg b.i.d. for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated). body weight < 40 kg (90 lb): 62.5 mg b.i.d.	Drug: Bosentan Initial dose: 62.5 mg b.i.d. for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated). body weight < 40 kg (90 lb): 62.5 mg b.i.d.
2: Placebo Comparator Initial dose: 62.5 mg b.i.d. for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated). body weight < 40 kg (90 lb): 62.5 mg b.i.d.	Drug: placebo Initial dose: 62.5 mg b.i.d. for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated). body weight < 40 kg (90 lb): 62.5 mg b.i.d.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391443

Show 123 Study Locations

Sponsors and Collaborators

Actelion

Investigators

Study Chair:

Isabelle Leconte

Actelion

More Information

Responsible Party:	Actelion ( Sebastien Roux, MD )
Study ID Numbers:	AC-052-321
Study First Received:	October 20, 2006
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00391443
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

bosentan
Tracleer
Actelion

BUILD 3
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease

Study placed in the following topic categories:

Lung Diseases, Interstitial
Respiratory Tract Diseases
Fibrosis
Hamman-Rich syndrome

Lung Diseases
Pulmonary Fibrosis
Bosentan

Additional relevant MeSH terms:

Pathologic Processes
Therapeutic Uses
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009