Iloprost Power 15 in Pulmonary Arterial Hypertension

NCT ID: NCT00709956

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-08-31

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).

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active / placebo

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

Group Type: EXPERIMENTAL

iloprost (5 µg)

Intervention Type: DRUG

Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

placebo

Intervention Type: DRUG

Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

Placebo / active

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

Group Type: PLACEBO_COMPARATOR

iloprost (5 µg)

Intervention Type: DRUG

Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

placebo

Intervention Type: DRUG

Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

Interventions

iloprost (5 µg)

Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

Intervention Type: DRUG

placebo

Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

Intervention Type: DRUG

Other Intervention Names

Ventavis(R)

Eligibility Criteria

Inclusion Criteria

• Signed informed consent prior to initiation of any study mandated procedure,
• Patients with symptomatic idiopathic, or familial pulmonary arterial hypertension or pulmonary hypertension associated with human immunodeficiency virus (HIV) or drugs/toxins in NYHA functional class II to IV.
• Women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug.

• Pulmonary arterial hypertension associated with significant venous or capillary involvement (Pulmonary capillary wedge pressure (PCWP) > 15 mmHg),
• Known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,
• Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration,
• Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,
• Pregnant or breast-feeding women,
• Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
• Systolic blood pressure < 95 mmHg,
• Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
• Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
• Clinically relevant bleeding disorder or active bleeding,
• For those patients on monotherapy, any contraindication to bosentan, ambrisentan, or sildenafil, according to product label,
• Known hypersensitivity to iloprost or any of its excipients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laila Rouault, MD

Role: STUDY_DIRECTOR

Actelion

Other Identifiers

AC-063A301

Identifier Type: -

Identifier Source: org_study_id