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Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan

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ClinicalTrials.gov Identifier: NCT00625469
Recruitment Status : Unknown
Verified February 2008 by University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : February 28, 2008
Last Update Posted : February 28, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that bosentan may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Idiopathic Pulmonary Fibrosis Drug: bosentan Other: No specific intervention Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study
Study Start Date : October 2007
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : December 2009


Arms and Interventions

Arm Intervention/treatment
Experimental: 1
patients with resting or exercise induced PAH receive bosentan in a randomized open label fashion
Drug: bosentan
62.5mg orally bid for first month, followed by 125mg bid thereafter
Active Comparator: 2
patients with resting or exercise PAH get randomized to receive no specific therapy
Other: No specific intervention
No specific intervention
No Intervention: 3
patients with no evidence of either resting or exercise PAH receive no intervention but are followed until lung transplantation
Other: No specific intervention
No specific intervention


Outcome Measures

Primary Outcome Measures :
  1. 6 minute walk distance [ Time Frame: monthly assessement until date of lung transplantation ]

Secondary Outcome Measures :
  1. right heart catheterization hemodynamics [ Time Frame: variable based on time between listing and actual lung transplantation ]
  2. chemokine peripheral blood analysis [ Time Frame: monthly ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Pulmonary Fibrosis referred for lung transplantation
  • Minimum 50 meter 6 minute walk distance
  • No significant underlying liver disease

Exclusion Criteria:

  • Significant liver disease or cirrhosis
  • non ambulatory
  • previous adverse reaction/allergy to Bosentan
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625469


Contacts
Contact: Michaela Dyke 310-825-5635 mdyke@mednet.ucla.edu
Contact: Rajan Saggar, MD 310-825-5635 rsaggar@mednet.ucla.edu

Locations
United States, California
David Geffen School of Medicine UCLA Recruiting
Los Angeles, California, United States, 90095-1690
Contact: Michaela Dyke    310-825-5635    mdyke@mednet.ucla.edu   
Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA Recruiting
Los Angeles, California, United States, 90095-1690
Contact: Rajan Saggar, M.D.    310-825-5635    rsaggar@mednet.ucla.edu   
Contact: Michaela Dyke    310-825-5635    mdyke@mednet.ucla.edu   
Principal Investigator: Rajan Saggar, M.D.         
Sub-Investigator: David J Ross, M.D.         
Sub-Investigator: John Belperio, M.D.         
Sub-Investigator: Joseph P Lynch, III, M.D.         
Sub-Investigator: Abbas Ardehali, M.D.         
Sub-Investigator: Rajeev Saggar, MD         
Sub-Investigator: David Zisman, MD         
Sponsors and Collaborators
University of California, Los Angeles
Actelion
Investigators
Principal Investigator: Rajan Saggar, MD University of California, Los Angeles
More Information

Responsible Party: Rajan Saggar, David Geffen School of Medicine UCLA
ClinicalTrials.gov Identifier: NCT00625469     History of Changes
Other Study ID Numbers: IPF/PAH
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: February 28, 2008
Last Verified: February 2008

Keywords provided by University of California, Los Angeles:
pulmonary arterial hypertension
idiopathic pulmonary fibrosis
bosentan

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Hypertension
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action