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Clinical Trials Detail

AIRES

AIRES: 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

Objective

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).

IRB Protocol Number
12-1341

All Other Trials

  • Lungs & Respiratory
Contact
Deb McCollister, RN at 720-848-6540
or Deb.McCollister@ucdenver.edu
Eligibility and Other Participant Information

Main Inclusion Criteria:

1) Age 18-75

2) WHO Group 1.1, 1.2, 1.3.1, 1.3.4, 1.3.5, (Idiopathic PAH, Heritable/Familial PAH, Drug- and toxin-induced PAH, PAH associated with collagen vascular disease, HIV infection) 1.3.2 repaired >1 year (PAH associated with congenital systemic-to-pulmonary shunts)

3) Functional class II - IV

4) mPAP >/= 25mm Hg, PVR >/= 240 dynes, PCWP or LVEDP </= 15mm Hg

5) TLC >/= 70%, FEV1 >/= 70%

6) Newly diagnosed PAH on no PAH-specific therapy or previously diagnosed PAH on stable (at least 90 days) prior to baseline study visit.

Main Exclusion Criteria:

1) History of uncontrolled systemic hypertension

2) History of obstructive sleep apnea

Location

  • University of Colorado Hospital (UCH)
    12605 E. 16th Ave.
    Aurora, CO 80045