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Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00709956
First received: July 1, 2008
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Pulmonary Arterial Hypertension
 Drug: iloprost (5 µg)
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Iloprost
U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:
  • 6-minute-walk Distance (6MWD) [ Time Frame: Study day 2 or study day 3 ] [ Designated as safety issue: No ]

    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:
  • Borg Dyspnea Score [ Time Frame: Study day 2 or study day 3 ] [ Designated as safety issue: No ]
    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.


Enrollment: 64
Study Start Date: July 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709956

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

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00709956     History of Changes
Other Study ID Numbers: AC-063A301
Study First Received: July 1, 2008
Results First Received: October 7, 2010
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013