Conditions: Chronic Obstructive Pulmonary Disease Pulmonary Hypertension
Keywords: PH COPD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system arm 2: matching placebo using the power disc-6 with I-neb AAD system

Interventions: intervention 1: Iloprost intervention 2: Placebo
Intervention descriptions: intervention 1: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks intervention 2: matching placebo

Protocol document: