Clinical trialNCT01725256TerminatedPhase 2Interventional

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

SponsorAires Pharmaceuticals, Inc.Enrollment29Pulmonary Arterial Hypertension

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Adaani E Frost, M.D.
Baylor College of Medicine
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

25 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

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

Hungary

Gottsegen Gyorgy Hungarian
Budapest, Hungary
Semmelweis Karlocai
Budapest, Hungary
University of Debrecen
Debrecen, Hungary
University of Szeged
Szeged, Hungary

United States

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
Boston University School of Medicine
Boston, Massachusetts, United States
Brigham and Women'S Hospital
Boston, Massachusetts, United States
Tufts Medical Center
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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AIR001

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Nov 2012
Primary completion: 28 Feb 2014
Completion: 28 Feb 2014
Last update posted: 9 Apr 2014
Registered enrollment: 29
Registry id: NCT01725256

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.