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.   

Research Focus and Current Studies

Alpha-1 Antitrypsin Deficiency (PI: Alan Barker, MD)

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

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 (SPARTA) NCT01983241

Asthma (PI: Shyam Joshi, MD)

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

Bronchiectasis (PI: Alan Barker, MD)

OHSU participates in the Bronchiectasis Research Registry.

A Double-Blind, Placebo Controlled, Multi-Centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy with Inhaled Colistimethate sodium in the Treatment of Subjects with Non-Cystic Fibrosis Bronchiectasis Chronically Infected with Pseudomonas Aeruginosa (PROMIS-II) NCT03460704

Idiopathic Pulmonary Fibrosis (PI: Daniel Seifer, MD)

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

Pulmonary Arterial Hypertension (PIs: Jeff Robinson, MD, and Raju Reddy, MD)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (STELLAR) NCT04576988

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) (TORREY study) NCT04456998

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 (ADVANCE Outcomes) 

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 (UNISUS) 

PACT Team

Photo of Samantha Ruimy
Samantha Ruimy, MS, CCRP
Outpatient Research Program Manager
Photo of Brennan Hand
Brennan Hand, BA
Senior Research Assistant
Photo of Lorenzo Redmond
Lorenzo Redmond, BA
Senior Research Assistant