Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)

A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00086463

Enrollment

Registered

2004-07-05

Start date

2004-06-30

Completion date

2006-01-31

Last updated

2011-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ayerza Syndrome, Pulmonary Arterial Hypertension, Pulmonary Hypertension

Keywords

STEP, PAH, iloprost, inhalation, prostacyclin

Brief summary

The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).

Detailed description

This is a randomized, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) with an NYHA Class of III or IV who are receiving conventional therapy and bosentan. Subjects who fulfill the inclusion and exclusion criteria will be randomized to study drug (active or placebo) at a frequency of 6-9 inhalations per day for 12 weeks and will continue conventional therapy and bosentan. At the end of the double-blind phase study, open label Iloprost will be provided.

Interventions

DRUGIloprost or placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of PAH due to PPH, connective tissue disease, HIV, or repaired (≥ 1 year) ASD, VSD, or PDA * NYHA Functional Class III or IV * On bosentan for at least 16 weeks, with the dose stable (maximum dose 125 mg BID) for at least 8 weeks * Age 12-75 years, of either gender * Six minute walk distance 100-425 meters at Baseline

Exclusion criteria

* Any new long-term treatment for PAH added within the last 4 weeks * Any therapy with a PDE (phosphodiesterase), L -arginine or a prostaglandin, concurrently, or within the last 4 weeks * PAH related to chronic thromboembolic disease, portopulmonary disease, or any etiology other than PPH, connective tissue disease, HIV, or repaired ASD, VSD, or PDA

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026