Evaluation of the efficacy of the dual endothelin 1 receptor antagonist Bosentan in the treatment of Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and in the treatment of Pulmonary Hypertension secondary to sarcoidosis

Phase 1

• Conditions: Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and secondary to Sarcoid Patients devolop pulmonary hypertension for various reasons, two common causes are Chronic Obstructive Pulmonary disease and Sarcoid. Once developed it may go on to cause right heart failure and severe breathlessness and eventually death. We believe that the use of bosentan may lower the pulmonary hypertension and improve symptoms.; MedDRA version: 8.1 Level: LLT Classification code 10037400 Term: Pulmonary hypertension

• Registration Number: EUCTR2006-005361-19-GB
• Lead Sponsor: St Georges Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-17
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

Any Patient with Chronic Obstructive Pulmonary Disease or Sarcoid with Pulmonary Hypertension. Pulmonary hypertension is defined as a mean pulmonary artery pressure in excess of 20mmHg at rest. Pulmonary hypertension is defined as an elevated mean pulmonary artery pressure of 20 mmHg or greater at rest or 30 mmHg with exercise.
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

Bosentan is contraindicated in patients with moderate to severe liver dysfunction and therefore this is an exclusion criteria.

There is limited experience with Bosentan in patients with a body weight below 40 kg, although this is not an absolute exclusion criteria this would require more frquent monintoring and is a relative contraindication for inclusion in the trial.

Excessive age is a relative contraindication given the number of clinic visits(>85 years old).

Children Safety and efficacy in patients under the age of 12 years have not been established so this is an exclusion criteria. (Age <12)

Pregnancy is absolute ecxlusion to the trial - therefore females entering the trial of child bearing age would need two forms of contraception and a pregnancy test prior to entry.

Study & Design

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