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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Actelion
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00625469
First received: February 19, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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 Intervention Phase
Pulmonary Arterial Hypertension
Idiopathic Pulmonary Fibrosis
 Drug: bosentan
Other: No specific intervention
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study

Resource links provided by NLM:

Drug Information available for: Bosentan
U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 6 minute walk distance [ Time Frame: monthly assessement until date of lung transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • right heart catheterization hemodynamics [ Time Frame: variable based on time between listing and actual lung transplantation ] [ Designated as safety issue: No ]
  • chemokine peripheral blood analysis [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rajan Saggar, David Geffen School of Medicine UCLA
ClinicalTrials.gov Identifier: NCT00625469     History of Changes
Other Study ID Numbers: IPF/PAH
Study First Received: February 19, 2008
Last Updated: February 19, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 18, 2013