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Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15)

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ClinicalTrials.gov Identifier: NCT00709956
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : October 26, 2012
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Actelion

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).

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: iloprost (5 µg) Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2008
Primary Completion Date : August 2009
Study Completion Date : August 2009


Arm Intervention/treatment
Experimental: Active / placebo
Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3
Drug: iloprost (5 µg)
Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
Other Name: Ventavis(R)
Drug: placebo
Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
Placebo Comparator: Placebo / active
Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3
Drug: iloprost (5 µg)
Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
Other Name: Ventavis(R)
Drug: placebo
Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc



Primary Outcome Measures :
  1. 6-minute-walk Distance (6MWD) [ Time Frame: Study day 2 or study day 3 ]

    The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk.

    It was conducted by a trained member of the site staff who was listed on the site's delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization.



Secondary Outcome Measures :
  1. Borg Dyspnea Score [ Time Frame: Study day 2 or study day 3 ]
    The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labeled "extremely severe," or "the worst possible dyspnea imaginable." Reliability and validity have been reported in a general population and in patients with PAH as well as other respiratory conditions.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709956


  Show 34 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Laila Rouault, MD Actelion

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00709956     History of Changes
Other Study ID Numbers: AC-063A301
First Posted: July 3, 2008    Key Record Dates
Results First Posted: October 26, 2012
Last Update Posted: September 28, 2015
Last Verified: March 2015

Keywords provided by Actelion:
Ventavis
iloprost
inhaled treatment
pulmonary arterial hypertension

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents