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Clinical Trials

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The Section of Pulmonary, Critical Care and Sleep Medicine (PCCSM) advances the research of pharmaceutical, biological and medical device products by developing collaborations between industry and academia. The Institute seeks to provide an efficient integration of academic expertise and industry clinical objectives. PCCSM offers its industry sponsors access to valuable scientific leadership, focused operational research functionality and analysis of high quality clinical trial data. As a leading provider of clinical trial services, PCCSM plays an important role in assessing new products that improve the quality of peoples’ lives.

Active Clinical Trials

Interstitial Lung Disease Program ( ILD )

Galapagos - A Phase 3, randomized, double-blind, parallel group, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of GLPG1690 in addition to local standard of care for minimum 52 weeks in subjects with idiopathic pulmonary fibrosis (IRES IRB ID:2000025140)

GALACTIC-1 - A randomized, double-blind, multicentre, parallel, placebo‑controlled Phase 2b study in subjects with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of TD139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler over 52 weeks (IRES IRB ID:2000025337)

Adult Cystic Fibrosis Program (CF)

G551D Observational Study- Expanded to Additional Genotypes and Extended for Long Term Follow up (GOAL- e2)
Status: Active - Enrolling.
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Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Receiving Porcine-derived Pancreatic Enzyme Replacement Therapy
Status: Active - Enrolling.
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A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis
Status: Active - Enrollment complete.
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Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Any Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)
Status: Active - Enrolling.
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OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis (OPTIMIZE)
Status: Waiting activation to start enrolling subjects.
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Center for Asthma and Airway Diseases (YCAAD)

For more information, see the Center for Asthma and Airway Diseases (YCAAD).

Center for Sleep Medicine
For more information, see the Center for Sleep Medicine.
COPD Center
Pending IRB approval.
Medical Intensive Care Unit (MICU)
The MIND-USA Study: Modifying the Impact of ICU-Associated Neurological
Status: Active - Enrolling.
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Pulmonary Vascular Disease Program (PVDP)

ASC01 - A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)
Status: Active - Enrolling.
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COMPASS2 - Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)
Status: Active - Closed to Enrollment.
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Thoracic Interventional Program (TIP)

RENEW (PneumRx): Lung Volume Reduction Coil for Treatment in Patients With Emphysema (RENEW) Study.
Status: Active - Enrolling
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ASPIRE (Aeris): Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE).
Status: Active - Enrolling
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ASAP (CareFusion/Duke): Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter on the Incidence of Auto-Pleurodesis in Patients With Malignant Pleural Effusions.
Status: Active - Enrolling
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Thoracic Oncology Program (TOP)
ADX-0001 (Allegro): Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer.
Status: Active - Closed to Enrollment
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Veteran's Administration - Pulmonary, Critical Care and Sleep Medicine
Pending IRB approval.