BUILD 3: Bosentan Use in Interstitial Lung Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00391443
First received: October 20, 2006
Last updated: May 24, 2012
Last verified: May 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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: 36 months ] [ Designated as safety issue: No ]
    Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).


Secondary Outcome Measures:
  • Percentage of Patients Who Experienced Either Disease Worsening or Death at 1 Year. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Disease worsening was defined as an event of worsening of pulmonary function tests (PFT) or acute exacerbation of idiopathic pulmonary fibrosis (IPF).


Enrollment: 616
Study Start Date: November 2006
Study Completion Date: July 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Initial dose: 62.5 mg twice daily (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.
Placebo Comparator: 2
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 117 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Isabelle Leconte Actelion
  More Information

No publications provided by Actelion

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00391443     History of Changes
Other Study ID Numbers: AC-052-321
Study First Received: October 20, 2006
Results First Received: April 25, 2012
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
bosentan
Tracleer
Actelion
BUILD 3
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014