Overview

Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)

Status:
Terminated

Trial end date:
2012-11-01

Target enrollment:
0

Participant gender:
All

Summary

This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to COPD. The main objective is to investigate the effect of iloprost on exercise endurance time during constant work rate cardiopulmonary exercise testing. Other efficacy and safety endpoints will additionally be analyzed.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Actelion

Treatments:

Iloprost

Criteria

Inclusion Criteria:

1. Signed informed consent prior to initiation of any study mandated procedure

2. Male or female ≥ 40 and ≤ 75 years of age

3. Women of childbearing potential1 must use a reliable method of contraception

4. Clinical diagnosis of moderate to severe COPD, with an obstructive pattern on
pulmonary function tests

5. Current or past smokers of ≥ 10 pack years

6. Ability to perform exercise testing without supplemental oxygen (in the best opinion
of the investigator)

7. Confirmed pulmonary hypertension by right heart catheterization (RHC)

Exclusion Criteria:

1. Other causes of pulmonary hypertension than COPD

2. BMI > 35 kg/m2

3. Conditions considered as contraindications for cardiopulmonary exercise testing (CPET)
and/or inability to pedal on a cycle ergometer

4. Pregnant or nursing

5. Currently (within 30 days prior to RHC) taking specific pulmonary arterial
hypertension (PAH) therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil,
epoprostenol, treprostinil, iloprost, beraprost)

6. Participation in any other clinical trial, except observational, or receipt of an
investigational product within 30 days prior to RHC visit

7. Known concomitant life-threatening disease with a life expectancy < 12 months

8. Known hypersensitivity to iloprost or any of the excipients of the drug formulations