Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing

Mallinckrodt

Status and phase: Completed; Phase 3

Conditions: Cardiomyopathy; Idiopathic Pulmonary Arterial Hypertension

Treatments: Drug: Nitric Oxide for inhalation; Drug: Nitric Oxide plus Oxygen; Drug: Oxygen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626028

INOT22

2004-000625-30 (EudraCT Number)

Details and patient eligibility

About

The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.

Enrollment: 136 patients

Sex: All

Ages: 4 weeks to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Must have any one of these three disease categories:

   • Idiopathic Pulmonary Arterial Hypertension

     • Mean pulmonary arterial pressure (PAPm) > 25 millimeters of mercury (mmHg) at rest, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and PVRI> 3 u•m^2 or diagnosed clinically with no previous catheterization

   • Congenital heart disease (CHD) with pulmonary hypertension repaired and unrepaired

     • PAPm > 25 mmHg at rest and PVRI> 3 u•m^2 or diagnosed clinically with no previous catheterization

   • Cardiomyopathy

     • PAPm > 25 mmHg at rest and Pulmonary vascular resistance index (PVRI)> 3 u•m^2 or diagnosed clinically with no previous catheterization

2. Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.

3. Male or female, ages 4 weeks to 18 years, inclusive

4. Signed informed consent/assent

Exclusion criteria

1. Focal pulmonary infiltrates on chest radiograph.
2. Diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient's pulmonary hypertension.
3. Received treatment with nitric oxide for inhalation within 30 days prior to study initiation, are on other investigational medications, nitroglycerin, sodium nitroprusside, sildenafil, other Phosphodiesterase type 5 (PDE-5) inhibitors, or prostacyclin
4. Pregnant [urine human chorionic gonadotropin positive (HCG +)]
5. Baseline Pulmonary capillary wedge pressure (PCWP) > 20 mmHg

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Nitric Oxide First, Oxygen Last

Experimental group

Description:

10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1.

Treatment:

Drug: Nitric Oxide plus Oxygen

Drug: Oxygen

Drug: Nitric Oxide for inhalation

Oxygen First, Nitric Oxide Last

Experimental group

Description:

10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1.

Treatment:

Drug: Nitric Oxide plus Oxygen

Drug: Oxygen

Drug: Nitric Oxide for inhalation