The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting

Actelion Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Pulmonary Hypertension

Treatments: Drug: Iloprost PD-6; Drug: Iloprost PD-15

Study type: Interventional

Funder types: Industry

Identifiers

NCT00467896

C200-008

Details and patient eligibility

About

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"

Enrollment: 62 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Iloprost

Experimental group

Description:

The study enrolled patients who were already using iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery (AAD) System with Power Disc-6 (PD-6) without any safety or tolerability concerns, thereby facilitating a direct comparison with the Power Disc-15 (PD-15). The single arm design allowed each patient to serve as his/her own control.

Treatment:

Drug: Iloprost PD-15

Drug: Iloprost PD-6