Pulmonary Ambulatory Clinical Trials

PACT

The Pulmonary Ambulatory Clinical Trials group is dedicated to conducting outpatient Phase 2 and Phase 3 drug studies in a range of pulmonary diseases. Based in the Division of Pulmonary, Allergy, and Critical Care Medicine, we have been carrying out industry and investigator-initiated studies since 2012. Our mission is to produce high-quality data, in partnership with our research participants, for evaluation of promising new treatments.   

PACT Team

Samantha Ruimy
Samantha Ruimy, MS, CCRP
Outpatient Research Program Manager
Lorenzo Redmond
Lorenzo Redmond, BA
Senior Research Assistant
Claire Milander-Mashlan
Claire Milander-Mashlan, BA
Senior Research Assistant

PACT Alumni

Brennan Hand
Brennan Hand, BA
Medical Student: Mayo Clinic, Scottsdale, AZ
Haeun Jung
Haeun Jung, AB
Medical Student: Stony Brook University, Stony Brook, NY

Research Focus and Current Studies

PI: Alan Barker, MD

PACCM is a nationally-recognized Clinical Resource Center through the Alpha-1 Foundation.

SPARTA: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alpha1 Proteinase Inhibitor (Human) in Subjects with Pulmonary Emphysema due to Alpha1-Antitrypsin Deficiency NCT01983241

PI: Shyam Joshi, MD

NIMBLE: A 52-week, randomized, double-blind, double-dummy, parallel group, multi-center, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with Mepolizumab or Benralizumab NCT04718389

PI: Alan Barker, MD

OHSU participates in the Bronchiectasis Research Registry, led by the COPD Foundation.

PI: Daniel Seifer, MD

STARSCAPE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis NCT04552899

PI: Alan Barker, MD

MIDAS: Multicenter International Durability and Safety of Sirolimus in LAM

LAM Foundation

PI: Jeffrey Robinson, MD

HYPERION: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-Risk PAH Patients NCT04811092

TORREY: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH) NCT04456998

ADVANCE Outcomes: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ralinepag when Added to Pulmonary Arterial Hypertension (PAH) Standard of Care or PAH-Specific Background Oral Therapy in Subjects with World Health Organization (WHO) Group 1 Pulmonary Hypertension NCT03626688 

UNISUS: A Phase 3, Prospective, Multicenter, Double-Blind, Double-Dummy, Randomized, Active-Controlled, Parallel-Group, Group-Sequential, Adaptive, Event-Driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75mg vs. Macitentan 10mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-Label Treatment Period with Macitentan 75mg NCT04273945