Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

Pulmonary Hypertension Clinical Trial

Official title:

Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02170519
• Other study ID #: Pro00013737
• Status: Terminated
• Phase: Phase 4
• First received: June 19, 2014
• Last updated: August 25, 2014
• Start date: September 2006
• Est. completion date: January 2009

Study information

• Verified date: June 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Inhaled Iloprost
A 20 mcg dose of Iloprost will be given initially.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Oxygen Saturation (SpO2) From Baseline	Readings were taken from the medical record and the data may not have been present at the exact time frames.	30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours	Yes
Primary	Percent Change in Oxygen Saturation (SpO2) From Baseline		dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)	No
Primary	Change in Mean Heart Rate From Baseline		30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours	Yes
Primary	Change in Mean Heart Rate From Baseline		dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)	No
Primary	Number of Treatment Failures	Treatment failure is defined as Central venous pressure (CVP) = 20 mm Hg and any one of the following: Cardiac Index (CI) >/= 1.8 L/min/m2; Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine; MAP SvO2	as long as subject was on drug up to approximately 24 hours	Yes
Primary	Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline		30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours	Yes
Primary	Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline		dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)	No
Secondary	Change in Cardiac Output (CO) From Baseline		30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours	Yes
Secondary	Change in Cardiac Output (CO) From Baseline		dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)	No
Secondary	Change in Mean Venous Oxygen Saturation (SvO2) From Baseline	SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.	30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours	Yes
Secondary	Change in Mean Venous Oxygen Saturation (SvO2) From Baseline		dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)	No