se of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertensio

Phase 1

• Conditions: Pulmonary hypertension in patients with interstitial lung disease.; MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension

• Registration Number: EUCTR2007-001643-21-GB
• Lead Sponsor: Royal Brompton and Harefield NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-10
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1. Patients >=18yrs, <80yrs

2. Patients with Idiopathic Pulmonary Fibrosis according to ATS/ERS criteria.

3. 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).

4. Patients providing written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients <18, >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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified