Clinical Research
The Division of Pulmonary, Critical Care, and Sleep Medicine conducts the following clinical research. Here, you’ll find the latest updates and status on many of the clinical trials being conducted.
For inquiries or potential study candidates, please email Lung@UHhospitals.org.
- Active & Recruiting
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Anemed Study
The purpose of this research study is to test the comfort and effectiveness of the Anemed Oral Appliance (the "AOA," Appliance, or "Anemed Oral Appliance") in treating sleep apnea. (PI: Strohl)
ASPEN Study
The purpose of this study is to evaluate the efficacy, safety, and tolerability of an experimental treatment, brensocatib, for NCFBE. (PI: Giddings)
COPD
RETHINC is a study that seeks to find out if an inhaled drug, indacaterol/glycopyrrolate, used to help people with COPD will improve the respiratory symptoms of those who do not meet the current criteria for COPD or asthma. Subjects must be 40 years old and be a current or former smoker with a 10+ pack per year smoking history. This study lasts approximately 12 weeks and requires 2 study visits. (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)
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 years old and have been diagnosed with IPF within 5 years of Screening. (PI: Folz/Matta)
Luminance Study
The purpose of this research study is to learn if using dual-energy CT scans will help in selecting the area in which valves should be placed. Researchers believe that using dual-energy CT scans may be a better way to assess blood flow to your lungs, which is important for planning a valve procedure.(PI: Avasarala)
Non-Cystic Fibrosis Bronchiectasis Study
A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects with Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas aeruginosa Infection . (PI: Gifford)
PACT Study
University Hospitals is actively enrolling participants in an interventional study to evaluate methods to identify and treat severe asthma patients. (PI: Ross)
Regeneron Study
The purpose of this study is to determine the safety and effectiveness of a study drug called dupilumab, on exercise capacity in people who have moderate-to-severe asthma. (PI: Teba)
Reliance Study
The purpose of this study is to compare two drugs, Azithromycin or Roflumilast, that doctors are planning to prescribe for their patients with Chronic Obstructive Pulmonary Disease. (PI: Teba)
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 years old 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) - Active - Closed to New Recruitment
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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)