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Pulmonary, Critical Care and Sleep Medicine

Clinical Research

As an academic institution, the division of Pulmonary, Critical Care & Sleep Medicine is able to offer opportunities to participate in a variety of clinical trials. MCW faculty are engaged in a variety of clinical research trials conducted in collaboration with research networks and industry sponsored-trials.

Pulmonary Medicine Clinical Trials

What are clinical trials and why do people participate?

What are clinical trials and why do people participate?

Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.

The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.

Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.

Ongoing clinical trials in Pulmonary, Critical Care & Sleep Medicine

Ongoing clinical trials in Pulmonary, Critical Care & Sleep Medicine

Ongoing clinical and translational research studies in the Division focus on improving outcomes and quality of life in patients with cystic fibrosis, developing new approaches to pulmonary arterial hypertension, and improving the care provided to ICU patients and their families.

Current pharmaceutical trials include the areas of cystic fibrosis, pulmonary hypertension and interstitial lung disease. The cystic fibrosis clinical studies are aimed at improving airway hydration and breathing, reducing infections and inflammation, increasing weight thereby increasing quality of life and perhaps survival time. Our pulmonary arterial hypertension program conducts studies to extend survival and an in-process study for individuals with ILD/IPF looks at a potential medication’s likelihood of becoming standard of care with the same aim. We have also recently completed a study for critically ill patients with direct acute lung injury that aims to improve time to end of assisted breathing and survival time.

Listed below are a few of our enrolling studies. If you do not see a condition that you are interested in please contact us. We may have opportunities that are in the development phase or may consider your inquiry for future studies.

Cystic Fibrosis (CF)

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Nitric Oxide

Title
Nitric Oxide
Novoteris LLC
Prospective, randomized, placebo controlled trial of the efficacy and safety of inhaled nitric oxide (NO) in cystic fibrosis (CF) patients

Study Purpose
The overall goal of this study is to evaluate an experimental treatment for people with Cystic Fibrosis who have a bacterial infection in their lungs. Subjects with a diagnosis with Cystic Fibrosis are invited to participate in the Nitric Oxide Study, if the participant meets the selection criteria. Nitric oxide gas is an approved drug at a lower concentration for a different indication that acts on the blood vessels in the lung by making them bigger. This study is an investigational use of nitric oxide. The duration of the study will be approximately 43 days.

Primary Investigator: Julie Biller, MD
Subinvestigators: Rose Franco, MD; Nancy Boll-Price, APNP
Status: Open – Currently Enrolling
ClinicalTrials.gov Identifier: NCT02498535

STOP2

Title
STOP2
Cystic Fibrosis Foundation Therapeutics
CF Therapeutics Development Network Coordinating Center
Medical University of South Carolina
University of Washington
Standardized Treatment of Pulmonary Exacerbations II (STOP2)

Study Purpose
This randomized, controlled, open-label study is designed to evaluate the efficacy and safety of differing durations of IV antibiotic treatment, given in the hospital or at home, for a pulmonary exacerbation in adult patients with CF.

Primary Investigator: Julie Biller, MD
Subinvestigator: Rose Franco, MD
Status: Open – Currently enrolling
ClinicalTrials.gov Identifier: NCT02781610

Pulmonary Arterial Hypertension (PAH)

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INCREASE 201

Title
INCREASE 201
United Therapeutics Corporation
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease.

Study Purpose
The overall goal of this study is to investigate the safety and how well inhaled treprostinil works in subjects with Pulmonary Hypertension associated with ILD or CPFE. Subjects diagnosed with Pulmonary Hypertension are invited to participate in INCREASE 201, if the participant meets the selection criteria. This study will look at the subject’s ability to exercise after taking the study drug. The planned duration of the study for each patient enrolled will be 20 weeks.

Primary Investigator: Kenneth W. Presberg, MD
Subinvestigators: David Ishizawar, MD; Gaurav Dagar, MD; Amy Kimber, APNP
Status: Open – Currently Enrolling
ClinicalTrials.gov Identifier: NCT02630316

LTI-301

Title
LTI-301
Liquidia Technologies
A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients.

Study Purpose
The overall goal of this study is to investigate the long-term safety and tolerability of LIQ861 in subjects with Pulmonary Arterial Hypertension. Subjects diagnosed with Pulmonary Arterial Hypertension are invited to participate in LTI-301, if the participant meets the selection criteria. This study will look at comparing LIQ861 to Tyvaso. The study will conclude when the FDA approves the study drug and it is commercially available or until the study is cancelled, or you withdraw from the study.

Primary Investigator: David Ishizawar, MD
Subinvestigators: Kenneth Presberg, MD; Gaurav Dagar, MD; Amy Kimber, APNP
Status: Open – Currently
ClinicalTrials.gov Identifier: NCT03399604

OPUS Registry for PAH
If you or someone you know has pulmonary arterial hypertension (PAH), they may qualify for a study at the Medical College of Wisconsin/Froedtert Hospital. This study is a multicenter, long-term, prospective, longitudinal, real-world, drug registry of Opsumit (macitentan) new users, and is a stand-alone observational study.

Patients will be followed by their physician according to routine clinical practice. The study protocol will not mandate any specific schedule of visits or investigations. All consecutive patients newly treated with Opsumit in the participating centers will be invited to enroll in the registry. The planned observation period for each patient enrolled into the registry will be at least 1 year from study enrollment or until death, withdrawal of consent, loss to follow-up, or Opsumit discontinuation with an elapsed time of 30 days after the last dosing day of Opsumit.

To see if you qualify or for more information, please contact a study coordinator at (414) 955-7040 or lung@mcw.edu.
SPHERE

Title
Uptravi (Selexipag): The Users Drug Registry (SPHERE)
Actelion

Study Purpose
The purpose of this Study is to better understand the demographic and clinical characteristics of PAH patients treated with Uptravi. Patients will be followed by their physician according to routine clinical care. The study protocol will not mandate any specific schedule of visits or procedures. All patients treated with Uptravi in the participating centers will be invited to enroll in the registry. The planned observation period for each patient enrolled into the registry will be about 18 months from study enrollment or until death, withdrawal of consent, loss to follow-up.

Primary Investigator: Kenneth Presberg, MD
Subinvestigators: David Ishizawar, MD; Guarav Dagar, MD; Amy Kimber, APNP
Status: Open – Currently Enrolling

Interstitial Lung Disease (ILD)

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IPF Team Idiopathic Pulmonary Fibrosis

Title
Targeted Intervention for Patient Centered Outcome in Patients with Idiopathic Pulmonary Fibrosis

Study Purpose
The primary objective of this study is to evaluate whether multi-disciplinary coordination of care in the rehabilitation setting will improve patient perceived quality of life.

Primary Investigator: Vijaya Ramalingam, MD
Subinvestigators: Terri deRoon Cassini, Linus Santo Tomas, Wendy Peltier, Rahul Nanchal, Randolph Lipchik
Status: New

Critical Care (CC)

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AVR-CPR

Title
Audiovisual tool use in the ICU, to impact the anxiety level of patients’ surrogates while deciding on Cardiopulmonary Resuscitation.

Study Purpose
To evaluate the impact of an audiovisual CPR tool on surrogate anxiety level using the HAM-A scale.

Primary Investigator: Tirsa M. Ferrer Marrero, MD
Subinvestigators: Jay Patel, MD

iPad Communication During Mechanical Ventilation

Title
Clinical & Translational Institute of Southeastern Wisconsin
A Randomized Controlled Trial of an iPad for Patient Communication during Mechanical Ventilation

Study Purpose
The primary objectives of this study are to evaluate whether use of an iPad improves a patient’s ability to communicate with their care team and family and also reduces feelings of anxiety and agitation.

Primary Investigator: Rahul Nanchal, MD, MS
Subinvestigators: Panna Codner, Terri deRoon Cassini, Jill Guttormson
Status: Open

MOF

Title
Clinical & Translational Science Institute of Southeast Wisconsin
Multiple Organ Failure (MOF) from Sepsis Causes Skeletal Muscle Mitochondrial (MT) Fragmentation and Dysfunction (MOF – MT Fray)

Study Purpose
The primary objective of this study is to characterize mt-fragmentation and mitochondrial function in clinical sepsis.

Primary Investigator: Rahul Nanchal, MD, MS
Subinvestigators: Elizabeth Jacobs, MD; Dominic Lee, MD; John Neilson, MD

SOS II

Title
SOS II
The Impact of Sarcopenic Obesity on Strength, Physical Functioning, and Pain Perception after Critical Illness

Study Purpose
The primary objective of this study is to correlate a novel method if interpreting CT scans of the abdomen with accepted measures of physical strength and pain perception.

Primary Investigator: Jayshil Patel, MD

Chronic Obstructive Pulmonary Disease (COPD)

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Alpha-1

Title
Alpha-1
A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple-Dose, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Hyaluronic Acid Inhalation Solution for the Treatment of Hereditary Emphysema in Patients with Alpha 1-Antitrypsin Deficiency for 28 days

Sponsor
MatRx Therapeutics

Study Purpose
The overall goal of this study is to evaluate an experimental treatment for people with alpha-1 antitrypsin deficiency (AATD) and emphysema. Subjects with a diagnosis of alpha-1 antitrypsin deficiency (AATD) and emphysema are invited to participate in the Alpha-1 Study, if the participant meets the selection criteria. Hyaluronic Acid is a common substance made by the human body and is found most commonly in the skin, joint fluid and eye. In the lungs, Hyaluronic Acid is present in the alveoli and in the smallest airways. This study is an investigational use of hyaluronic acid. The duration of this study will be approximately 35 days.

Primary Investigator: Randolph Lipchik, MD
Status: Open – Currently Enrolling
ClinicalTrials.gov Identifier: NCT03114020

Clinical Research Staff

Jayshil Patel, MD

pateljayshil

Director of Clinical Research

Amy Blair

amy-blair

Clinical Research Coordinator I
(414) 955-7007
lung@mcw.edu

Jeanette Graf

jeanettegraf_2015

Clinical Research Manager
(414) 955-6987
lung@mcw.edu

Rachel Harris

rachelharris_2015

Clinical Research Coordinator III
(414) 955-7030
lung@mcw.edu

Erin Hubertz

erinhubertz_2015

Clinical Research Coordinator II
(414) 955-7019
lung@mcw.edu

Shama Sharwani

shama-sharwani

Systems Specialist
(414) 955-7064
lung@mcw.edu

Ashley Wuerl

ashley-wuerl

Clinical Research Coordinator II
(414) 955-7036
lung@mcw.edu

Stephanie Zellner

stephaniezellner

Clinical Research Coordinator III
(414) 955-7085
lung@mcw.edu