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

Primary Purpose

Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bosentan
Sponsored by
Rajan Saggar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring pulmonary arterial hypertension, idiopathic pulmonary fibrosis, bosentan

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • David Geffen School of Medicine UCLA
  • Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

treatment with bosentan

PAH group with no therapy

No PAH and no therapy

Arm Description

patients with resting or exercise induced PAH receive bosentan in a randomized open label fashion

patients with resting or exercise PAH get randomized to receive no specific therapy

patients with no evidence of either resting or exercise PAH receive no intervention but are followed until lung transplantation

Outcomes

Primary Outcome Measures

6 minute walk distance
ATS Guideline 6MW distance before and after intervention

Secondary Outcome Measures

right heart catheterization hemodynamics
pulmonary hemodynamics
chemokine peripheral blood analysis
battery of chemokines analyzed from the peripheral blood

Full Information

First Posted
February 19, 2008
Last Updated
March 2, 2018
Sponsor
Rajan Saggar
Collaborators
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00625469
Brief Title
Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan
Official Title
Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
competing studies did not allow enrollment
Study Start Date
October 2007 (Actual)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rajan Saggar
Collaborators
Actelion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, Idiopathic Pulmonary Fibrosis
Keywords
pulmonary arterial hypertension, idiopathic pulmonary fibrosis, bosentan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment with bosentan
Arm Type
Experimental
Arm Description
patients with resting or exercise induced PAH receive bosentan in a randomized open label fashion
Arm Title
PAH group with no therapy
Arm Type
No Intervention
Arm Description
patients with resting or exercise PAH get randomized to receive no specific therapy
Arm Title
No PAH and no therapy
Arm Type
No Intervention
Arm Description
patients with no evidence of either resting or exercise PAH receive no intervention but are followed until lung transplantation
Intervention Type
Drug
Intervention Name(s)
bosentan
Other Intervention Name(s)
tracleer
Intervention Description
62.5mg orally bid for first month, followed by 125mg bid thereafter
Primary Outcome Measure Information:
Title
6 minute walk distance
Description
ATS Guideline 6MW distance before and after intervention
Time Frame
monthly assessement until date of lung transplantation
Secondary Outcome Measure Information:
Title
right heart catheterization hemodynamics
Description
pulmonary hemodynamics
Time Frame
variable based on time between listing and actual lung transplantation
Title
chemokine peripheral blood analysis
Description
battery of chemokines analyzed from the peripheral blood
Time Frame
monthly

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajan Saggar, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Geffen School of Medicine UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1690
Country
United States
Facility Name
Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1690
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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