Clinical trial NCT00709956: Iloprost Power 15 in Pulmonary Arterial Hypertension
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: Ventavis
iloprost
inhaled treatment
pulmonary arterial hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: 6-minute-walk Distance (6MWD)
timeFrame: Study day 2 or study day 3
Secondary outcomes:
measure: Borg Dyspnea Score
timeFrame: Study day 2 or study day 3
Other outcomes:
Locations:
Study officials:
affiliation: Actelion
name: Laila Rouault, MD
role: STUDY_DIRECTOR
References: