NCT00709956

Iloprost Power 15 in Pulmonary Arterial Hypertension

A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	iloprost (5 µg)	Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
DRUG	placebo	Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-07-03
• Last updated: 2025-02-04
• Results posted: 2012-10-26