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Bosentan in Pulmonary Hypertension in Interstitial Lung Disease Treatment Study

NCT00637065 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2008-03-17

No results posted yet for this study

Summary

Over time, patients with fibrosing or interstitial lung disease (ILD) can develop high lung blood pressures (pulmonary hypertension), and this is associated with poorer prognosis and survival. It is thought that development of PH contributes to the deterioration and death of patients with ILD. Endothelin-1 (ET1) is a substance contributing to the development of both PH and ILD. Bosentan is a drug blocking the action of ET-1 by binding to its receptors. Bosentan clearly benefits patients with PH of unknown cause, or related to other diseases (such as heart conditions, or HIV) both alone and in combination with other treatments. In patients with fibrosing lung disease and PH, there have been no controlled treatment studies. Clearly it is important to evaluate the effectiveness of bosentan in these patients.

This study aims to determine the ability of bosentan to reduce high blood pressure in the lungs (pulmonary hypertension) in patients with scarring (fibrosing) lung disease. It is a placebo-controlled double blinded study for 16 weeks (and it is proposed to follow patients in a 16 week open-label phase with bosentan therapy).

Conditions

Interventions

DRUG

Bosentan

Bosentan tablets - 62.5mg bd for first 4 weeks, then 125mg bd if tolerated until trial completion.

DRUG

Placebo

Placebo tables - identical to active drug but without the active ingredient -

Sponsors & Collaborators

  • Actelion

    collaborator INDUSTRY

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Stephen J Wort, FRCP PhD · Royal Brompton Hospital, London

  • Athol U Wells, MD FRCP FRCR · Royal Brompton Hospital, London

  • Luke Howard, DPhil MRCP · Hammersmith Hospitals NHS Trust

  • Brendan Madden, MD MSc FRCP · Royal Brompton & Harefield NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-04-30
Completion
2010-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637065 on ClinicalTrials.gov