Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15)

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: placebo; Drug: iloprost (5 µg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00709956

AC-063A301

Details and patient eligibility

About

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).

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Active / placebo

Experimental group

Description:

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

Treatment:

Drug: iloprost (5 µg)

Drug: placebo

Placebo / active

Placebo Comparator group

Description:

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

Treatment:

Drug: iloprost (5 µg)

Drug: placebo