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

NCT00625469 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: IPF/PAH
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis

Keywords

pulmonary arterial hypertension; idiopathic pulmonary fibrosis; bosentan

Outcome Measures

Primary Outcomes (1)

• 6 minute walk distance

  ATS Guideline 6MW distance before and after intervention

  monthly assessement until date of lung transplantation

Secondary Outcomes (2)

• right heart catheterization hemodynamics

  variable based on time between listing and actual lung transplantation

• chemokine peripheral blood analysis

  monthly

Study Arms (3)

treatment with bosentan

EXPERIMENTAL

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

Drug: bosentan

PAH group with no therapy

NO INTERVENTION

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

No PAH and no therapy

NO INTERVENTION

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

Interventions

bosentan DRUG

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

Also known as: tracleer

treatment with bosentan

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rajan Saggar: lead
• Actelion: collaborator

Study Sites (2)

David Geffen School of Medicine UCLA

Los Angeles, California, 90095-1690, United States

Location

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

Los Angeles, California, 90095-1690, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis; Lung Diseases, Interstitial

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rajan Saggar, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: October 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 6, 2018

Record last verified: 2018-03

Locations

US (2)