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| Sponsor: | Actelion |
|---|---|
| Information provided by: | Actelion |
| ClinicalTrials.gov Identifier: | NCT00071461 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
1: Experimental
Initial dose: 62.5 mg b.i.d. for 4 weeks.
|
Drug: bosentan
Initial dose: 62.5 mg b.i.d. for 4 weeks.
|
|
2: Placebo Comparator
Initial dose: 62.5 mg b.i.d. for 4 weeks.
|
Drug: Placebo
Initial dose: 62.5 mg b.i.d. for 4 weeks.
|
Eligibility| 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).
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama at Birmingham - Pulmonary Division | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| University of California - Ambulatory Care Center | |
| San Francisco, California, United States, 94143 | |
| David Geffen School of Medicine at UCLA - Division of Pulmonary and Critical Care Medicine | |
| Los Angeles, California, United States, 90024 | |
| UCSD Medical Center | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| National Jewish Medical and Research Center | |
| Denver, Colorado, United States, 80204 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Jackson Memorial Hospital | |
| Miami, Florida, United States, 33136 | |
| United States, Iowa | |
| University of Iowa Hospitals & Clinics - Department of Internal Medicine | |
| Iowa city, Iowa, United States, 52242 | |
| United States, Michigan | |
| University of Michigan Health System - Division of Pulmonary & Critical Care Medicine | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Mayo Medical School - Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| University of Washington - Division of Pulmonary & Critical Care Medicine | |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| University of Wisconsin Hospitals & Clinics - Section of Pulmonary and Critical Care Medicine | |
| Madison, Wisconsin, United States, 53792 | |
| Canada, British Columbia | |
| University of British Columbia - St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Canada, Ontario | |
| Rosedale Medical Center | |
| Toronto, Ontario, Canada, M4X 1W4 | |
| Canada, Quebec | |
| Notre-Dame Hospital - Clinique du Thorax | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| France | |
| Hôpital Avicenne - Université de Paris | |
| Bobigny, France | |
| Hôpital Louis Pradel | |
| Lyon, France, 69000 | |
| Médecine Spécialisée Aigüe - CHU Grenoble | |
| Grenoble, France, 38043 | |
| Germany | |
| Medizinische Klinik und Poliklinik I Klinikum der Universität München | |
| Munchen, Germany | |
| Abt. Pneumologie Medizinische Klinik Universitätsklinikum Freiburg | |
| Freiburg, Germany | |
| Klinik Löwenstein gGmbH | |
| Loewenstein, Germany | |
| Israel | |
| Sheba Medical Center | |
| Tel-Hashomer, Israel | |
| Italy | |
| Section of Respiratory Diseases - Policlinico Le Scotte - Siena University | |
| Siena, Italy | |
| Switzerland | |
| Inselspital | |
| Bern, Switzerland | |
| United Kingdom | |
| Royal Brompton Hospital | |
| London, United Kingdom | |
More Information
| 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 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Idiopathic pulmonary fibrosis Interstitial lung disease Bosentan BUILD |
|
Lung Diseases, Interstitial Pathologic Processes Respiratory Tract Diseases Fibrosis Therapeutic Uses Lung Diseases |
Cardiovascular Agents Antihypertensive Agents Pulmonary Fibrosis Pharmacologic Actions Bosentan |