Iloprost Power 15 in Pulmonary Arterial Hypertension

NCT00709956 | Completed Phase 3 Results

• 1 other identifier: AC-063A301
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pulmonary Arterial Hypertension

Keywords

Ventavis; iloprost; inhaled treatment; pulmonary arterial hypertension

Outcome Measures

Primary Outcomes (1)

• 6-minute-walk Distance (6MWD)

  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.

  Study day 2 or study day 3

Secondary Outcomes (1)

• Borg Dyspnea Score

  Study day 2 or study day 3

Study Arms (2)

Active / placebo

EXPERIMENTAL

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

Drug: iloprost (5 µg); Drug: placebo

Placebo / active

PLACEBO COMPARATOR

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

Drug: iloprost (5 µg); Drug: placebo

Interventions

iloprost (5 µg) DRUG

Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

Also known as: Ventavis(R)

Active / placebo; Placebo / active

placebo DRUG

Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

Active / placebo; Placebo / active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actelion: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Laila Rouault, M.D.
• Organization: Actelion

laila.rouault@actelion.com

+ 41 61 565 8128

Study Officials

• Laila Rouault, MD

  Actelion

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 4, 2025
• Results First Posted: October 26, 2012

Record last verified: 2025-01