DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension

Intervention: Inhaled Iloprost (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Neil MacIntyre, MD, Principal Investigator, Affiliation: Duke University

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.

Clinical Details

Official title: Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percent Change in Oxygen Saturation (SpO2) From Baseline

Percent Change in Oxygen Saturation (SpO2) From Baseline

Change in Mean Heart Rate From Baseline

Change in Mean Heart Rate From Baseline

Number of Treatment Failures

Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline

Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline

Secondary outcome:

Change in Cardiac Output (CO) From Baseline

Change in Cardiac Output (CO) From Baseline

Change in Mean Venous Oxygen Saturation (SvO2) From Baseline

Change in Mean Venous Oxygen Saturation (SvO2) From Baseline

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: September 2006
Last updated: August 25, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017