Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

NCT02170519 | Terminated Phase 4 Results

• 1 other identifier: Pro00013737
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension

Outcome Measures

Primary Outcomes (7)

• 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

• 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)

• 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

• 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)

• Number of Treatment Failures

  Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following: 1. Cardiac Index (CI) \>/= 1.8 L/min/m2 2. Administration of \>/=0.1 ug/kg/min Epinephrine or Norepinephrine 3. MAP \</= 50 mmHg (or as appropriate for age in pediatrics). 4. SvO2\</= 55% (or \< 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}

  as long as subject was on drug up to approximately 24 hours

• 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

• 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)

Secondary Outcomes (4)

• 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

• 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)

• Change in Mean Venous Oxygen Saturation (SvO2) From Baseline

  30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours

• 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)

Study Arms (2)

Phase 2: Inhaled Iloprost continuous

EXPERIMENTAL

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.

Drug: Inhaled Iloprost

Phase 1: Inhaled Iloprost 3 doses

EXPERIMENTAL

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.

Drug: Inhaled Iloprost

Interventions

Inhaled Iloprost DRUG

A 20 mcg dose of Iloprost will be given initially.

Also known as: Ventavis

Phase 1: Inhaled Iloprost 3 doses; Phase 2: Inhaled Iloprost continuous

Eligibility Criteria

• Age: 1 Year - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.
• Indwelling arterial catheter.
• Signed informed consent

You may not qualify if:

• Clinically unstable circulatory condition requiring epinephrine \> 0.1 mcg/kg/min or levophed, or already meeting treatment failure criteria (see section 5.3 below)
• Known hypersensitivity to prostacyclin compounds
• Patients receiving sildenafil or bosentan
• Refusal by the attending physician

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Neil MacIntyre, MD
• Organization: Duke University Medical Center

neil.macintyre@dm.duke.edu

919-681-2720

Study Officials

• Neil MacIntyre, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: September 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: October 15, 2024
• Results First Posted: August 26, 2014

Record last verified: 2014-06