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

NCT ID: NCT00625469

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-12-31

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.

Conditions

Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment with bosentan

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

Group Type: EXPERIMENTAL

bosentan

Intervention Type: DRUG

62.5mg orally bid for first month, followed by 125mg bid thereafter

PAH group with no therapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

No PAH and no therapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

bosentan

62.5mg orally bid for first month, followed by 125mg bid thereafter

Intervention Type: DRUG

Other Intervention Names

tracleer

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: collaborator

Rajan Saggar

OTHER

Sponsor Role: lead

Responsible Party

Rajan Saggar

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rajan Saggar, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

David Geffen School of Medicine UCLA

Los Angeles, California, United States

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

Los Angeles, California, United States

Countries

United States

Other Identifiers

IPF/PAH

Identifier Type: -

Identifier Source: org_study_id