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 and participates in the Therapeutic Development Network (TDN).

ELEVAATE-OLE: Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults with Alpha-1 Antitrypsin Deficiency Emphysema NCT05897424

PI: Shyam Joshi, MD

No active trials at this time

PI: Alan Barker, MD

博彩网站 participates in the Bronchiectasis Research Registry, led by the COPD Foundation.

PI: Daniel Seifer, MD

ALOFT-IPF: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Idiopathic Pulmonary Fibrosis NCT06003426

ALOFT-PPF: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis NCT06025578

PI: Alan Barker, MD

MIDAS: Multicenter International Durability and Safety of Sirolimus in LAM

LAM Foundation

PI: Jeffrey Robinson, MD

SOTERIA: An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH NCT04796337

PROSERA: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH) NCT05934526

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

DECIPHER-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) NCT06388421

PI: Julianna Desmarais, MD

CONQUEST: Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants with Interstitial Lung Disease Secondary to Systemic Sclerosis NCT06195072