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Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis



Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis

For Condition: Idiopathic Pulmonary Fibrosis
Status: Recruiting
Sponsor(s): Actelion ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Main inclusion criteria: - IPF proven diagnosis < 3 years, according to ATS/ERS consensus statement (with or without surgical lung biopsy). - Six-minute walk distance limited by dyspnea. Main exclusion criteria: - Interstitial Lung Disease (ILD) due to conditions other than IPF. - FVC < 50% predicted or < 1.2 liter. - DLco < 30 % of predicted. - Severe obstructive lung disease. - PaO2 < 55 mmHg. - Treatments with immunosuppressive, antifibrotic drugs, high dose corticosteroids (within 4 weeks from randomization). - Significant pulmonary arterial hypertension.
Total Enrollment: 

Location and Contact Information:

Rosedale Medical Center *Recruiting*
Toronto,  Ontario, 
Canada
Recruiting Charles  Chan 416-340-3235

Jackson Memorial Hospital *Not yet recruiting*
Miami,  Florida, 
United States
Not yet recruiting Marylin  Glassberg 305-243-6388

Medizinische Klinik und Poliklinik I Klinikum der Universität München *Recruiting*
MĂĽnchen,  , 
Germany
Recruiting JĂĽrgen  Behr + 49 89-70-95-30-71

University of Pennsylvania *Recruiting*
Philadelphia,  Pennsylvania, 
United States
Recruiting Milton  Rossman 215-615-0276

Vanderbilt University Medical Center *Recruiting*
Nashville,  Tennessee, 
United States
Recruiting Lisa  Lancaster 615-754-0315

University of Alabama at Birmingham - Pulmonary Division *Recruiting*
Birmingham,  Alabama, 
United States
Recruiting Joao  DeAndrade 205-934-7557

University of British Columbia - St. Paul's Hospital *Recruiting*
Vancouver,  British Columbia, 
Canada
Recruiting Robert  Levy 604-806-8931

University of California - Ambulatory Care Center *Recruiting*
San Francisco,  California, 
United States
Recruiting Jeffrey  Golden 415-353-2935

Yale University School of Medicine *Recruiting*
New Haven,  Connecticut, 
United States
Recruiting Paul  Noble 203-785-7324

HĂ´pital Louis Pradel *Recruiting*
Lyon,  ,  69000
France
Recruiting Jean  Cordier + 33 472 357 652

David Geffen School of Medicine at UCLA - Division of Pulmonary and Critical Care Medicine *Recruiting*
Los Angeles,  California, 
United States
Recruiting David  Zisman 310-825-8689

Sheba Medical Center *Recruiting*
Tel Hashomer,  , 
Israel
Recruiting Issahar  Dov + 972 35-30-27-35

Abt. Pneumologie Medizinische Klinik Universitätsklinikum Freiburg *Recruiting*
Freiburg,  , 
Germany
Recruiting Joachim  MĂĽller-Quernheim + 49 761-270-37-06

Mayo Medical School - Mayo Clinic *Recruiting*
Rochester,  Minnesota, 
United States
Recruiting Sanjay  Kalra 507-284-2447

Section of Respiratory Diseases - Policlinico Le Scotte - Siena University *Recruiting*
Siena,  , 
Italy
Recruiting Paola  Rottoli + 39 0577-586-710

University of Michigan Health System - Division of Pulmonary & Critical Care Medicine *Recruiting*
Ann Arbor,  Michigan, 
United States
Recruiting Fernando  Martinez 734-763-2540

Klinik Löwenstein gGmbH *Recruiting*
Löwenstein,  , 
Germany
Recruiting Gerd  Stähler + 49 7130-15-208

New York Presbyterian Medical Center for Chest Disease *Recruiting*
New York City,  New York, 
United States
Recruiting Neil  Schluger 212-305-1158

University of Wisconsin Hospitals & Clinics - Section of Pulmonary and Critical Care Medicine *Recruiting*
Madison,  Wisconsin, 
United States
Recruiting Keith  Meyer 608-263-6363

Notre-Dame Hospital - Clinique du Thorax *Recruiting*
Montreal,  Quebec, 
Canada
Recruiting Charles  Poirier +1 514-890-8000

University of Iowa Hospitals & Clinics - Department of Internal Medicine *Recruiting*
Iowa City,  Iowa, 
United States
Recruiting Gary  Hunninghake 415-353-2935

Royal Brompton Hospital *Not yet recruiting*
London,  , 
United Kingdom
Not yet recruiting Athol  Wells +44 207-352- 81-21

Inselspital *Recruiting*
Bern,  , 
Switzerland
Recruiting Thomas  Geiser + 41 31-632-27-68

National Jewish Medical and Research Center *Recruiting*
Denver,  Colorado, 
United States
Recruiting Kevin  Brown 303-398-1621

University of Washington - Division of Pulmonary & Critical Care Medicine *Recruiting*
Seattle,  Washington, 
United States
Recruiting Ganesh  Raghu 206-598-4967

UCSD Medical Center *Recruiting*
San Diego,  California, 
United States
Recruiting Gordon  Yung 619-543-7300

Médecine Spécialisée Aigüe - CHU Grenoble *Recruiting*
Grenoble,  ,  38043
France
Recruiting Christophe  Pison + 33 476 76 87 32

Tulane University Health Sciences Center *Recruiting*
New Orleans,  Louisiana, 
United States
Recruiting Chodie  Gabor 504-585-6966

Hôpital Avicenne - Université de Paris *Recruiting*
Bobigny,  , 
France
Recruiting Dominique  Valeyre + 33 1-48-95-51-21

University of Pittsburgh *Not yet recruiting*
Pittsburgh,  Pennsylvania, 
United States
Not yet recruiting James  Dauber 412-648-6161

Baylor College of Medicine *Recruiting*
Houston,  Texas, 
United States
Recruiting Adaani  Frost 713-790-2076


Additional Information:
Study ID Numbers:
  BUILD 1;  AC-052-320
Study Start Date: August 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071461

Other Idiopathic Pulmonary Fibrosis Studies:
1. A study of the safety and efficacy Interferon-gamma 1b in patients with Idiopathic Pulmonary Fibrosis (IPF)

2. The INSPIRE Trial: A Study of Interferon gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)

3. An Open-Label Study of the Safety of Interferon gamma-1b in Patients with IPF

4. Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF)

5. Safety and Tolerability Study of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis

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Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis

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