Iloprost Power 15 in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: iloprost (5 µg); placebo
Intervention description: Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc; Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
Intervention MeSH terms: Iloprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ventavis; iloprost; inhaled treatment; 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).
    

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.

        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.