A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension (PAH)

Stopped early · Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT01725256

Run by

Aires Pharmaceuticals, Inc.

People needed

29

Starts

2012-11-01

Expected to finish

2014-02-01

Last updated by the study team

2014-04-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• A qualification cardiac catheterization, to confirm the persistence and severity of PAH, if the diagnostic catheterization was performed more than 30 days prior to Baseline
• Confirms diagnosis;
• PVR above 300 dyn.sec/cm5 to demonstrate the persistence and severity of PAH; and
• No change in disease-specific PAH therapy since the qualification catheterization used
• Newly diagnosed PAH on no disease-specific PAH therapy or previously diagnosed on oral disease-specific PAH therapy for 90 days prior with either an ETRA and/or PDE-5i
• Has PFTs within 180 days prior to Baseline with no evidence of significant parenchymal lung disease defined as:
• FEV1 ≤ 70% (predicted) (pre-bronchodilators);
• FEV1/FVC ≤ 70% (pre-bronchodilators); or
• Total lung capacity < 70% (predicted).
• Has WHO/NYHA FC II- IV.
• ≥ 18 and ≤ 75 years.
• Weight ≥ 40 kg.
• Has 6MWT distance at least 50 meters.
• Had a V/Q scan or pulmonary angiogram prior to Screening that shows no evidence of thromboembolic disease
• If on the following: vasodilators (including calcium channel blockers), digoxin, spironolactone, or L-Arginine; must be on a stable dose 30 days prior to Baseline and maintained throughout the study

You may not qualify if…

• 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%
• Left ventricular shortening fraction < 22% by ECHO prior to Screening;
• Symptomatic coronary disease
• Significant (2+ for regurgitation) valvular disease other than TR or PR
• Acutely decompensated heart failure within 30 days prior to Baseline
• History of atrial septostomy within 180 days prior to Baseline
• History of obstructive sleep apnea (treated, untreated or resolved)
• Diagnosis of Down syndrome
• Moderate to severe hepatic impairment
• Has chronic renal insufficiency as defined by serum creatinine > 2.5 mg/dL or has an eGFR < 30 mL/min at Screening, or requires dialysis
• Has a Hgb concentration < 8.5 g/dL at Screening
• Personal or family history of the following:
• Congenital or acquired methemoglobinemia;
• RBC CYPB5 reductase deficiency
• G6PD deficiency or any contraindication to receiving methylene blue
• For subjects with HIV any of the following:

Where it is running

• UCSD Medical Center — La Jolla, California, United States
• UCLA Medical Center — Torrance, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• St. Vincent's Hospital — Darlinghurst, New South Wales, Australia
• The Prince Charles Hospital — Chermside, Queensland, Australia
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Gottsegen Gyorgy Hungarian — Budapest, Hungary
• Semmelweis Karlocai — Budapest, Hungary
• University of Debrecen — Debrecen, Hungary
• University of Szeged — Szeged, Hungary

Full record on ClinicalTrials.gov

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