Conditions: Pulmonary Arterial Hypertension
Keywords: Ventavis iloprost inhaled treatment pulmonary arterial hypertension
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 64
Healthy volunteers: no

Brief summary:
Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human immunodeficiency virus (HIV) or drugs/toxins in New York Heart Association (NYHA) functional class II to IV at baseline, naive to PAH treatment or currently being treated with a stable dose of either bosentan, ambrisentan or sildenafil will be enrolled in the PROWESS 15 study. This randomized, double blind, placebo-controlled, crossover, and single-dose study will determine whether a single inhaled dose of iloprost using the power 15 disc improves exercise capacity compared to placebo in patients with pulmonary arterial hypertension (PAH).

Detailed description:

Arms:
arm 1: Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3 arm 2: Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3

Interventions: intervention 1: iloprost (5 µg) intervention 2: placebo
Intervention descriptions: intervention 1: Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc intervention 2: Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

Protocol document: