Status:
UNKNOWN
Bosentan in Pulmonary Hypertension in Interstitial Lung Disease Treatment Study
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsors:
Actelion
Conditions:
Pulmonary Hypertension
Interstitial Lung Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 t...
Detailed Description
• Purpose: High blood pressure in the lungs or pulmonary hypertension (PH) is a common complication of fibrosing (or interstitial, ILD) lung disease. When present, it is associated with markedly reduc...
Eligibility Criteria
Inclusion
- Patients \>=18yrs, \<80yrs
- Patients with idiopathic pulmonary fibrosis (IPF) or idiopathic fibrotic non-specific interstitial pneumonitis (NSIP) confirmed by their respiratory physician according to ATS/ERS criteria.
- Patients with pulmonary hypertension on right heart catheter (mean pulmonary arterial pressure \>=25mmHg with pulmonary artery occlusion pressure, left atrial pressure or left ventricular end-diastolic pressure \<15mmHg).
- Patients providing written informed consent.
Exclusion
- Patients \<18, \>80yrs.
- Patients with unstable disease, or an acute exacerbation of their underlying fibrotic lung disease.
- Patients with significant other organ co-morbidity including hepatic or renal impairment.
- Patients with systolic BP \< 85mmHg
- Patients with other conditions that may affect the ability to perform a 6-minute walk test.
- Patients unable to provide informed consent and comply with the patient protocol.
- Patients receiving excluded medications (including: epoprostenol, or prostacyclin analogues, phosphodiesterase inhibitors, other endothelin receptor antagonists, drugs with potential interaction with bosentan such as glibenclamide, fluconazole, cyclosporin A, or tacrolimus, and other investigational agents).
- Patients with planned surgical intervention during the study period.
- Pregnant patients or women of child-bearing age, who are not using a reliable contraceptive method.
- Patients with clinically overt ischaemic heart disease.
- Patients with predominant emphysema on high resolution CT scan (emphysema greater in extent than interstitial changes).
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00637065
Start Date
April 1 2008
End Date
August 1 2010
Last Update
March 17 2008
Active Locations (3)
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1
St George's Hospital
London, London, United Kingdom, SW1 O7QT
2
Royal Brompton Hospital
London, London, United Kingdom, SW3 6NP
3
Hammersmith Hospital
London, London, United Kingdom, W12 OHS