Iloprost Power 15 in Pulmonary Arterial Hypertension
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).
Timeline
- Start
- 2008-07
- Primary completion
- 2009-08
- Completion
- 2009-08
Outcome
Missed primary endpoint
registry 6MWD After Placebo Treatment vs 6MWD After Iloprost (5 µg) Treatment; p = 0.7883 NCT00709956 ↗
registry Difference in least squares mean -1.5 (95% CI -12.3 to 9.4) NCT00709956 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iloprost | Other / unclassified | 5 ug | Inhaled |