The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution
 delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"
Inclusion Criteria:

 -  Male or female, aged 18-85 years

 -  Have a current diagnosis of symptomatic pulmonary arterial hypertension (PAH)
 classified by one of the following: a) idiopathic pulmonary arterial hypertension
 (IPAH) or familial pulmonary arterial hypertension (FPAH); b) PAH associated with one
 of the following connective tissue diseases and mild or no lung parenchymal disease:
 scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective
 tissue disease, c) PAH associated with repaired atrial septal defect (ASD),
 ventricular septal defect (VSD), or patent ductus arteriosis (PDA) ≥ 1 year
 post-operative from Screening, d) PAH associated with human immunodeficiency virus
 (HIV), or e) PAH associated with the use of anorexigens (e.g.
 fenfluramine-phentermine)

 -  On a stable and well tolerated dose regimen of Ventavis (5 μg per dose) for at least 4
 weeks prior to the Screening visit, using the I-neb AAD System equipped with Power
 Disc-6

 Exclusion Criteria:

 -  Receipt of any prostacyclin or prostacyclin analogue other than Ventavis within the 12
 weeks preceding the Screening visit

 -  Receipt of atrial septostomy within the 6 months preceding Screening

 -  History of left-sided heart disease

 -  Clinically relevant obstructive lung disease

 -  Chronic renal or liver disease

 -  Uncontrolled systemic hypertension or hypotension

 -  Cerebrovascular event within the 6 months preceding Screening