Pulmonary hypertension in patients with interstitial lung disease. MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension
Conditions
Interventions
Trade Name: Tracleer
Product Name: Tracleer
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bosentan
CAS Number: 147536-97-
Sponsors
Royal Brompton and Harefield NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients >=18yrs, 25mmHg with pulmonary artery occlusion pressure, left atrial pressure or left ventricular end-diastolic pressure =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients 80yrs. 2. Patients with unstable disease, or an acute exacerbation of their underlying fibrotic lung disease. 3. Patients with significant other organ co-morbidity including hepatic or renal impairment. 4. Patients with systolic BP < 85mmHg 5. Patients with other conditions that may affect the ability to perform a 6-minute walk test. 6. Patients unable to provide informed consent and comply with the patient protocol. 7. 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 invesgational agents). 8. Patients with planned surgical intervention during the study period. 9. Pregnant patients or patients of child bearing capacity who are using a reliable contraceptive method. 10. Patients with clinically overt ischaemic heart disease 11. Patients with predominant emphysema on CT scan (greater than interstitial changes)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of bosentan in treatment of patients with pulmonary hypertension and fibrosing lung disease. The primary endpoints is a fall from baseline pulmonary vascular resistance (PVR) to week 16 of 20%. ; Secondary Objective: To assess whether bosentan improves exercise capacity, and pulmonary blood flow in patients with pulmonary hypertension and fibrosing lung disease. The secondary endpoints are changes from baseline to week 16 in the following: 1. right heart catherisation (RHC) parameters: mean pulmonary arterial pressure, right atrial pressure, cardiac index, systemic vascular resistance. 2. Exercise capacity as measured by the 6-minute walk test, and Borg dyspnoea scale 3. Quality of life as measured by the CAMPHOR questionaire 4. Pulmonary blood flow 5. Lung function (DLco% predicted, FVC% predicted, Composite physiological index) 6. WHO functional class 7. Right ventricular mass (cardiac MRI) 8. Brain natriuretic peptide ; Primary end point(s): The primary end point is - Fall from baseline PVR (to week 16) of 20%. | — |
Countries
United Kingdom
Outcome results
None listed