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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Recruitment Status : Withdrawn (competing studies did not allow enrollment)
First Posted : February 28, 2008
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Rajan Saggar, University of California, Los Angeles

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 Phase 4

Detailed Description:
The purpose of this study was to evaluate bosentan in the setting of exercise or resting pulmonary hypertension in patients with underlying pulmonary fibrosis.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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
Actual Study Start Date : October 2007
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : December 2009


Arm Intervention/treatment
Experimental: treatment with bosentan
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
Other Name: tracleer

No Intervention: PAH group with no therapy
patients with resting or exercise PAH get randomized to receive no specific therapy
No Intervention: No PAH and no therapy
patients with no evidence of either resting or exercise PAH receive no intervention but are followed until lung transplantation



Primary Outcome Measures :
  1. 6 minute walk distance [ Time Frame: monthly assessement until date of lung transplantation ]
    ATS Guideline 6MW distance before and after intervention


Secondary Outcome Measures :
  1. right heart catheterization hemodynamics [ Time Frame: variable based on time between listing and actual lung transplantation ]
    pulmonary hemodynamics

  2. chemokine peripheral blood analysis [ Time Frame: monthly ]
    battery of chemokines analyzed from the peripheral blood



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Ages Eligible for Study:   Child, Adult, Older Adult
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

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


Locations
United States, California
David Geffen School of Medicine UCLA
Los Angeles, California, United States, 90095-1690
Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095-1690
Sponsors and Collaborators
Rajan Saggar
Actelion
Investigators
Principal Investigator: Rajan Saggar, MD University of California, Los Angeles

Responsible Party: Rajan Saggar, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00625469     History of Changes
Other Study ID Numbers: IPF/PAH
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes

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

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