A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH)

Aires Pharmaceuticals, Inc.25 sites in 3 countries29 target enrollmentNovember 2012

ConditionsPulmonary Arterial Hypertension

InterventionsAIR001 (sodium nitrite inhalation solution)

DrugsAIR001 (sodium nitrite inhalation solution)

Overview

Phase: Phase 2
Intervention: AIR001 (sodium nitrite inhalation solution)
Conditions: Pulmonary Arterial Hypertension
Sponsor: Aires Pharmaceuticals, Inc.
Enrollment: 29
Locations: 25
Primary Endpoint: Change in pulmonary vascular resistance (PVR)from baseline to week 16 assessed at peak AIR001
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of an investigational/experimental drug called AIR001.

To test the effectiveness, the study will evaluate how AIR001 affects the blood vessels in the lungs and the function of the heart. This will be done by monitoring changes in Pulmonary Vascular Resistance (PVR); from Baseline/Day 1 (start of study drug) to Week 16 of the study. PVR measures the resistance to flow in the blood vessels of the lungs. The study will include other assessments to evaluate the effect of the study drug on PAH, including measurements of exercise ability and evaluations of PAH disease symptoms.

Detailed Description

The primary objective of this study is to evaluate the efficacy of inhaled nebulized AIR001 administered, for 16 weeks, according to 3 treatment arms (80 mg once daily, 46 mg 4 times daily, or 80 mg 4 times daily) in subjects with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH), as determined by change in Pulmonary Vascular Resistance (PVR) from Baseline to Week 16 measured immediately post completion of AIR001 nebulization (as soon as feasible).

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

February 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aires Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed and dated informed consent document
•Able to comply with study procedures
•Diagnosis of PAH as classified by:
•Idiopathic (IPAH) or heritable(HPAH); or
•PAH associated with CTD; Systemic Sclerosis, Limited Scleroderma, Mixed, SLE, or overlap syndrome;
•PAH associated with HIV ii. Simple, congenital shunts at least one year post repair. iii. Exposure to legal drugs, chemicals and toxins
•Cardiac catheterization prior to Screening with:
•mPAP ≥ 25 mmHg (at rest);
•PCWP ≤ 15 mmHg; and
•PVR \> 3 mmHg/L/min or 240 dyn.sec/cm5

Exclusion Criteria

•Participation in a device or other interventional clinical studies, within 30 days of Baseline and during study participation
•Participation in a cardio-pulmonary rehabilitation program based upon exercise within 30 days prior to Baseline and/or during the study
•Has uncontrolled systemic hypertension: SBP \> 160 millimeter of mercury (mmHg) or DBP \> 100 mmHg during Screening
•SBP \< 90 mmHg at Screening or Baseline
•History of orthostatic hypotension or at the time of Screening; defined as a drop in SBP by ≥ 20 mmHg or DBP of ≥ 10 mmHg during Screening
•History of left-sided heart disease and/or clinically significant cardiac disease, including:
•Aortic or mitral valve disease (stenosis or regurgitation) defined as greater than mild;
•Pericardial constriction;
•Restrictive or congestive cardiomyopathy;
•Left ventricular ejection fraction \< 40%