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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00071461 |
Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis.
Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available.
The present trial investigates a possible use of bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a new category of patients suffering from IPF.
The BUILD 1 showed, although not statistically significant, positive trends for pre-defined secondary endpoints, such as the combined incidence of death or treatment failure at 12 months.
It was therefore decided to offer Open Label treatment (bosentan) for patients willing to continue in the BUILD 1 study.
Condition | Intervention | Phase |
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Idiopathic Pulmonary Fibrosis |
Drug: bosentan Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis |
Enrollment: | 158 |
Study Start Date: | August 2003 |
Study Completion Date: | November 2005 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Initial dose: 62.5 mg b.i.d. for 4 weeks.
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Drug: bosentan
Initial dose: 62.5 mg b.i.d. for 4 weeks.
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2: Placebo Comparator
Initial dose: 62.5 mg b.i.d. for 4 weeks.
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Drug: Placebo
Initial dose: 62.5 mg b.i.d. for 4 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
1.Male or female patients over 18 years of age.
Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination.
2.IPF proven diagnosis < 3 years documented according to ATS/ERS international multidisciplinary consensus, with or without surgical (thoracoscopic or open) chest lung biopsy 3.Duration of illness ≥ 3 months. 4.Six-minute walk test distance (limited by dyspnea) ≥ 150 meters and < 500 meters 5.Patients who have signed the informed consent form prior to initiation of any study procedure.
Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements, e.g., the 6MWT or the PFTs.
(e.g., angina pectoris, intermittent claudicating, chronic arthritis).
Responsible Party: | Actelion ( Sebastien Roux, MD ) |
Study ID Numbers: | AC-052-320, BUILD 1 |
Study First Received: | October 23, 2003 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00071461 |
Health Authority: | United States: Food and Drug Administration |
Idiopathic pulmonary fibrosis Interstitial lung disease Bosentan BUILD |
Lung Diseases, Interstitial Respiratory Tract Diseases Fibrosis Hamman-Rich syndrome |
Lung Diseases Pulmonary Fibrosis Bosentan |
Pathologic Processes Therapeutic Uses Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |