Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

NCT ID: NCT02170519

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-01-31

Brief Summary

Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this condition. The evidence supporting INO safety and efficacy under these circumstances is sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as iloprost may be a favorable alternative therapy.

Detailed Description

Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time.

Phase 2 - All remaining subjects received Iloprost as a continuous treatment.

The study was designed for an enrollment of 200 subjects and was ended early.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 2: Inhaled Iloprost continuous

Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.

A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.

Group Type: EXPERIMENTAL

Inhaled Iloprost

Intervention Type: DRUG

A 20 mcg dose of Iloprost will be given initially.

Phase 1: Inhaled Iloprost 3 doses

Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.

A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.

Group Type: EXPERIMENTAL

Inhaled Iloprost

Intervention Type: DRUG

A 20 mcg dose of Iloprost will be given initially.

Interventions

Inhaled Iloprost

A 20 mcg dose of Iloprost will be given initially.

Intervention Type: DRUG

Other Intervention Names

Ventavis

Eligibility Criteria

Inclusion Criteria

1. Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.

2. Indwelling arterial catheter.

3. Signed informed consent

Exclusion Criteria

1. Clinically unstable circulatory condition requiring epinephrine > 0.1 mcg/kg/min or levophed, or already meeting treatment failure criteria (see section 5.3 below)

2. Known hypersensitivity to prostacyclin compounds

3. Patients receiving sildenafil or bosentan

4. Refusal by the attending physician

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil MacIntyre, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

Pro00013737

Identifier Type: -

Identifier Source: org_study_id