Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

Brief Title

Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

Official Title

Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Percent Change in Oxygen Saturation (SpO2) From Baseline

Secondary Outcome

 Change in Cardiac Output (CO) From Baseline

Condition

Pulmonary Hypertension

Intervention

Inhaled Iloprost

Study Arms / Comparison Groups

 Phase 2: Inhaled Iloprost continuous
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

27

Start Date

September 2006

Completion Date

January 2009

Primary Completion Date

January 2009

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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Neil MacIntyre, MD, , 



Administrative Informations


NCT ID

NCT02170519

Organization ID

Pro00013737


Responsible Party

Sponsor

Study Sponsor

Duke University


Study Sponsor

Neil MacIntyre, MD, Principal Investigator, Duke University


Verification Date

June 2014