Clinical Trials

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.

 

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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Pending IRB approval.

Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis

The overall objective of the study is to evaluate the safety, tolerability, and efficacy of FG-3019 in subjects with idiopathic pulmonary fibrosis (IPF)

Conditions:
Diseases of the Respiratory Systems

Principal Investigator:
Danielle Antin-Ozerkis
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A Study of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in patients with idiopathic pulmonary fibrosis. Patients will be randomized to receive either lebrikizumab or placebo subcutaneously very 4 weeks.

Conditions:
Diseases of the Respiratory Systems

Principal Investigator:
Danielle Antin-Ozerkis
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A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

Conditions:
Diseases of the Lung
Diseases of the Respiratory Systems

Principal Investigator:
Danielle Antin-Ozerkis
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A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with IPF.

Conditions:
Diseases of the Respiratory Systems

Principal Investigator:
Danielle Antin-Ozerkis
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The MIND-USA Study: Modifying the Impact of ICU-Associated Neurological
Status: Active - Enrolling.
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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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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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ADX-0001 (Allegro): Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer.
Status: Active - Closed to Enrollment
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