Clinical Research

COPD
RETHINC is a study that seeks to find out if an inhaled drug used to help people with COPD . indacaterol/glycopyrrolate . will improve the respiratory symptoms of those who do not meet the current criteria for COPD or asthma. Subjects must be . 40 y.o. and be a current or former smoker with a 10+ packyear smoking history. This study lasts approximately 12 weeks and requires 2 study visits. Our target enrollment goal is 20 patients. 8 patients have already been successfully enrolled. (PI: Folz)

EDURO Study
The purpose of this study is to compare the effects, good or bad, of omalizumab versus placebo on your ability to do physical activity and improve sleep for patients with allergic asthma. In this study, you will receive either omalizumab or placebo. A placebo looks like a drug but has no active ingredient. (PI: Folz)

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PACT Study
University Hospitals is actively enrolling participants in an interventional study to evaluate methods to identify and treat severe asthma patients. (PI: Ross)

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Idiopathic Pulmonary Fibrosis (IPF)
CELGENE is a study that is investigating the efficacy and safety of drug CC-90001 in subjects with IPF. It is hypothesized that c-Jun N-terminal kinase (JNK) plays a pivotal role in the progression of IPF and that JNK inhibition, by CC-90001, will lead to improved lung function and other outcomes in IPF patients. CC-9001 will be administered at doses of either 200 mg or 400 mg, compared to a placebo, over the course of 24 weeks. Subjects must be . 40 y.o. and have been diagnosed with IPF within 5 years of Screening. We aim to enroll 3 patients in this study. (PI: Folz/Matta)

Sepsis
VISTA is a NIH-funded study which models brainstem inflammation's role in systemic dysfunction during sepsis. This project seeks to model critically-ill humans at risk for sepsis by evaluating heart rate variability and brainstem cardiorespiratory control networks. Subjects must be > 18 y.o. and must have been admitted to the ICU with a projected length of stay > 72 hours for cardiorespiratory monitoring or those with signs of infection (SIRS . 2). Subjects will be followed for 7 days or until time of discharge from the ICU. (PI: Dick/Jacono)

Tuberculosis (TB)
The laboratory of Dr. Richard Silver has devoted over 20 years of work to understanding immunity to Mycobacterium tuberculosis, the bacteria that causes TB. The ultimate application of this work is to assess the potential protective effects of new TB vaccines now in development. Healthy volunteers with a history of positive TB skin tests or blood tests are continually recruited for participation in research blood drawing as well as bronchoscopy procedures to obtain immune cells from the lungs. Healthy non-smokers with no history of lung disease can also participate as control subjects. (PI: Silver)

Acute Respiratory Distress Syndrome (ARDS)
A Phase 1/2 study is being conducted to assess the safety, efficacy, and tolerability of MultiStem® therapy in Subjects with ARDS. 10 patients were successfully enrolled to meet our target accrual goal. We are continuing to follow up with these patients. (PI: Jacono/Hejal/Teba)

Asthma
Asthma in Older Adults is a NIH-funded project whose goal is to identify phenotypes and factors impacting outcomes in older adults with asthma. We successfully recruited 190 asthmatics, 60 y.o. and older, and performed extensive phenotyping and home environmental assessments, sputum-induced biomarker testing, as well as skin prick testing. We are currently in the data analysis stage. (PI: Folz)

COPD
INSIGHT investigated whether a lifestyle program that promotes modest weight loss and increased physical activity will improve COPD symptoms for those with a high BMI. 12 patients have been enrolled and our site was recognized by the PTC for our incredibly successful recruitment efforts. We are continuing to follow up with these patients. (PI: Folz)

AIRWISE looked to compare COPD exacerbations in patients who are prescribed Stiolto Respimat compared to patients prescribed Triple Therapy. Our target accrual goal of 10 patients was successfully met, and we are continuing to follow up with these patients. (PI: Folz)

Obstructive Sleep Apnea (OSA)
Belun Ring is a study evaluating the accuracy of the Belun Ring device, an innovative single-channel four-signal pulse oximetry, in patients referred to sleep lab for assessment of OSA. 85 patients were successfully enrolled and we are currently in the data analysis stage. (PI: Chiang)

Pulmonary Hypertension
RIN 201/202 is evaluating the safety and efficacy of inhaled Treprostinil in subjects with Pulmonary Hypertension due to Parenchymal Lung Disease. Two patients are currently enrolled in this study and we are continuing to monitor their progress. (PI: Schilz)

COPD
RELIANCE aims to compare roflumilast and azithromycin to determine which therapy is best for the prevention of COPD exacerbations. Patients must be . 40 years old, be a smoker of 10+ pack years, have a diagnosis of severe COPD and associated chronic bronchitis, and be on inhaled LAMA, LABA/LAMA, or ICS/LABA. Patients must also have been hospitalized with a diagnosis of COPD exacerbation in the past 12 months. This study is projected to open for accrual in January 2020. (PI: Folz)

Idiopathic Pulmonary Fibrosis (IPF)
BI-Pulmonary Rehab seeks to determine the difference in change in Quality of Life when pulmonary rehabilitation is added to stable underlying nintedanib therapy in patients with IPF. Patients must be . 40 years old and on a stable dose of nintedanib for 3 to 30 months. This study is projected to open for accrual by the end of this year. (PI: Folz/Matta)

SLEEP
LOFT-HF is a sleep study looking to evaluate the long-term effects of Nocturnal Oxygen Therapy on the mortality and morbidity of patients with stable heart failure (HF) and a reduced ejection fraction, already receiving optimal guideline-directed medical therapy, who have central sleep apnea. Patients must be . 21 years old with . 1 hospitalization for HF in the last 24 months. This study is projected to open for accrual by the end of this year. (PI: Chiang)