Clinical Research in Pulmonary, Critical Care, and Sleep Medicine | Pulmonary, Critical Care and Sleep Medicine | Department of Internal Medicine | UC Davis Health

Study Title: A Phase 3/4 Study to Evaluate the Safety, Immunogenicity, and Effects on the Alpha1-Proteinase Inhibitor (A1PI) Levels in Epithelial Lining Fluid Following GLASSIA Therapy in A1PI-Deficient Subjects

• Study Type: A Phase III/IV device trial
• Purpose: The purpose of this research is to evaluate the safety and potential immunogenicity of a currently approved drug, GLASSIA (an α-1 proteinase inhibitor) and to assess the effects augmentation therapy on the levels of A1PI and various biomarkers in the epithelial lining fluid (ELF) following intravenous (IV) administration in subjects with emphysema due to congenital A1PI deficiency
• More information: clinicaltrials.gov
• Principal Investigator: Brian Morrissey, M.D.
• Study contact:
  • Tina Tham, CCRP phone: 916-734-3351 email: ttham@ucdavis.edu

Study Title:Alpha-1 Clinical Resource Center Research

• Study Type: Registry and biorepository
• Purpose: To create larger, well-characterized patient cohorts to support alpha-1 antitrypsin deficiency (α-1AT) clinical trials; to aid in the clinical management of α-1AT; to monitor trends in α-1AT population and increase the understanding, treatment, and survival of α-1AT disease.
• Principal Investigator: Carroll Cross, M.D.
• Study contact: 
  • Maya Juarez, CCRC phone: 916-734-3643 email: mmjuarez@ucdavis.edu

Study Title:  L-arginine in Severe Asthma Patients Grouped by Exhaled Nitric Oxide Levels

• Study Type: A Phase II drug trial
• Purpose: The purpose of this study is to identify the type of adult patients with severe asthma that will benefit from supplemental L-arginine therapy. The investigators hypothesize that a subset of adult severe asthma patients will respond to supplemental L-arginine and derive clinical benefit from the addition of this therapy to standard-of-care asthma medications.
• More information: clinicaltrials.gov
• Principal Investigator: Nicholas Kenyon, M.D.
• Study contact:
  • Celeste Kivler, RRT phone: 916-734-8380 email: ckivler@ucdavis.edu
  • Nicholas Kenyon, M.D. phone: 916-734-3564 email: nkenyon@ucdavis.edu
  • Amir Zeki, M.D. phone: 916-734-3564 email: aazeki@ucdavis.edu

Study Title: The Asthma-COPD Overlap Syndrome: Pilot Study and Cohort Development

• Study Type: Pilot study
• Purpose: The goal of this study is to determine whether patients with asthma-COPD overlap syndrome (ACOS) have greater airway and systemic inflammation as compared to asthma and COPD, and to organize a UC Davis  cohort of patients with ACOS (as part of our long-standing UCAN Asthma Clinics) in order to study them longitudinally and recruit for future randomized clinical trials.  Specific Aim #1) To determine if patients with ACOS have evidence of more severe lower airways and systemic inflammation than patients with asthma or COPD alone.  Specific Aim #2) Ro determine if patients with ACOS have worse lung function than age-adjusted patients with asthma or COPD.
• Principal Investigator: Amir Zeki, M.D.
• Study contact:
  • Amir Zeki, M.D. phone: 916-734-3566 or 530-754-5469 email: aazeki@ucdavis.edu
  • Samuel Louie, M.D. phone: 916-734-3564 email: sylouie@ucdavis.edu

Study Title: The Modulation of Eotaxin Expression by Statins: Implications for Asthma Therapy

• Study Type: Randomized, controlled trial
• Purpose: The overall aims of this project are to understand the mechanisms by which statins regulate gene expression of the eotaxins, potent eosinophil chemokines, and in doing so elucidate general underlying principles of the statin effect on a wider array of genes involved in TH2 lung inflammation relevant to allergic asthma and COPD. We focus on IL-13-induced JAK/STAT6 transcriptional regulation of eotaxin-2 and -3 and propose novel mechanisms whereby statins modulate STAT6 activation and downstream signaling. Aim 3 is a pilot 30-week cross-over randomized, placebo-controlled clinical trial to evaluate the effect simvastatin on TH2 airway inflammation (IL-13, the eotaxins, STAT6 activation, lung %eosinophils) and important clinical outcomes (acute exacerbations, lung function (FEV1), and symptom control (ACT score)).
• Principal Investigator: Amir Zeki, M.D.
• Study contact: Amir Zeki, M.D. phone: 916-734-3566 or 530-754-5469 email: aazeki@ucdavis.edu

Study Title: A Study Evaluating the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Patients with Uncontrolled Asthma

• Study Type: A Phase II drug trial
• Purpose:The purpose of this study is to evaluate the effects of lebrikizumab on airway eosinophilic inflammation in patients with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controlled medication.
• More information: clinicaltrials.gov
• Principal Investigator: Nicholas Kenyon, M.D.
• Study contact: Celeste Kivler, RRT phone: 916-734-8380 email: ckivler@ucdavis.edu

Study Title: Effects of psychosocial stress on glucocorticoid responsiveness in severe asthma

• Study Type: Observational Study
• Purpose: This study aims to gather preliminary data to determine whether glucocorticoid receptor responsiveness to exogenous steroids is inhibited in severe asthmatic patients; to evaluate impairment in GR responsiveness with respect to T-helper cell type phenotype; and to examine the relationship between psychosocial stress in patients with high Th2 phenotype and impaired GR responsiveness.
• Principal Investigator: Nicholas Kenyon, M.D.
• Study contact: Celeste Kivler, RRT phone: 916-734-8380 email: ckivler@ucdavis.edu

Study Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis

• Study Type: A Phase II drug trial
• Purpose: This study will evaluate the safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF
• More information: clinicaltrials.gov
• Principal Investigator: Brian Morrissey, MD
• Study Contact: Kaitlyn Kirk, CCRC phone: 916-734-8686 email: kkirk@ucdavis.edu

Study Title: Participation in Cystic Fibrosis Patient Registry

• Purpose: Patient Registry
• Principal Investigator: Brian Morrissey, M.D.
• Study contact: Kaitlyn Kirk, CCRC phone: 916-734-8686 email: kkirk@ucdavis.edu

Study Title: STOP2: Treatment of pulmonary exacerbations in people with CF

• Purpose: This study will look at the safety and effectiveness of different lengths of IV treatment for pulmonary exacerbations in people with CF
• More information: clinicaltrials.gov
• Principal Investigator: Brian Morrissey, MD
• Study Contact: Kaitlyn Kirk, CCRC phone: 916-734-8686 email: kkirk@ucdavis.edu

Study Title: A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients with Cystic Fibrosis treated with Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors

• Study Type: Patient Registry
• Purpose: This study will evaluate the incidence of and risk factors for fibrosing colonopathy in patients with CF
• More information: clinicaltrials.gov
• Principal Investigator: Brian Morrissey, M.D.
• Study Contact: Kaitlyn Kirk, CCRC phone: 916-734-8686 email: kkirk@ucdavis.edu

Study Title: Reevaluation of Systemic Early neuromuscular blockade (ROSE)

• Study Type: A Phase III drug trial
• Purpose: This study will evaluate the safety and efficacy of early neuromuscular blockade in reducing mortality and morbidity in patients with moderate-severe acute respiratory distress syndrome (ARDS) in comparison to a control group with no routine early neuromuscular blockade.
• More information: clinicaltrials.gov; http://petalnet.org/
• Principal Investigator: Timothy Albertson, M.D., Ph.D.
• Study contact: Skyler Pearson phone: 916-734-3867 email: sjpearson@ucdavis.edu

Study Title: Phase Ib/IIa, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-936559 in Subjects with Severe Sepsis

• Study Type: A Phase II drug trial
• Purpose: Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.
• More information:clinicaltrials.gov
• Principal Investigator: Timothy Albertson, M.D., Ph.D.
• Study contact: John Tushinski phone: 916-734-3866 email: jrtushinski@ucdavis.edu 

Study Title: A Phase III Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects with Staphylococcus aureus Bacteremia Including Infective Endocarditis

• Study Type: A Phase III device trial
• Purpose: The purpose of this research is to compare telavancin to standard intravenous therapy (ie, vancomycin, daptomycin, anti-staphylococcal penicillin, or cefazolin) clinical outcomes in the treatment of S. aureus bacteremia including S. aureus right-sided infective endocarditis.
• More information: clinicaltrials.gov
• Principal Investigator: Christian Sandrock, M.D.
• Study contact: Tina Tham, CCRP phone: 916-734-3351 email: ttham@ucdavis.edu

Study Title: A phase 2, 24-week, randomized, double-blind, placebo-controlled, multicenter study, followed by a 28-week treatment extension, to evaluate the efficacy and safety of CC-90001 in subjects with Idiopathic Pulmonary Fibrosis.

• Study Type: A Phase II drug trial
• Purpose: This study will evaluate the safety and efficacy of CC-90001, an anti-fibrotic and anti-inflammatory JNK-1 inhibitor, in patients with Idiopathic Pulmonary Fibrosis (IPF) who are not currently receiving any anti-fibrotic therapies (like pirfenidone or nintedanib).
• More information: clinicaltrials.gov
• Principal Investigator: Brian Morrissey, M.D
• Study contact: Elena Foster phone: 916-734-3650 email: eefoster@ucdavis.edu

Study Title: A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

• Study Type: A Phase III drug trial
• Purpose: This study will evaluate the safety and efficacy of nintedanib in patients who have progressive fibrosing interstitial lung disease (PF-ILD). While nintedanib is an anti-fibrotic approved for patients with Idiopathic Pulmonary Fibrosis (IPF), the current study aims to test it for patients diagnosed with a variety of interstitial lung diseases, including hypersensitivity pneumonitis (HP), connective tissue disease related ILD (CTD-ILD) and many others.
• More information: clinicaltrials.gov
• Principal Investigator: Justin Oldham, M.D
• Study contact: Elena Foster phone: 916-734-3650 email: eefoster@ucdavis.edu

Study Title: Interstitial Lung Disease Clinical and Biospecimen Registry

• Study Type: Patient Registry
• Purpose: To create a central repository of information pertaining to persons interested in enrolling in and/or learning about ILD research, including clinical trials. The subject pool data may also be used to determine eligibility for future invitation to participate in research; to evaluate study outcomes; to determine the feasibility of future ILD trials at this site.
• Principal Investigator: Brian Morrissey, M.D.
• Study contact: Maya Juarez, CCRC phone: 916-734-3643 email: mmjuarez@ucdavis.edu

Study Title: Bronchiectasis Clinical Data and Specimen Registry

• Study Type: Patient Registry
• Purpose: To create a central repository of clinical information from persons interested in enrolling in and/or learning about bronchiectasis research, including clinical trials. The subject pool data may also be used to further study bronchiectasis or determine eligibility for future invitation to participate in research; to evaluate study outcomes; to determine the feasibility of future bronchiectasis trials at this site.
• Principal Investigator: Brian Morrissey, M.D.
• Study contact: Maya Juarez, CCRC phone: 916-734-3643 email: mmjuarez@ucdavis.edu

Study Title: Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)

• Study Type: A Phase III drug study 
• Purpose: The purpose of this research is to study the investigational drug oral treprostinil in patients who have pulmonary hypertension due to heart failure with preserved ejection fraction
• More information: clinicaltrials.gov
• Principal Investigator: Roblee Allen, M.D.
• Study contact: 
  • Nikhil Jaha phone: 916-734-1554 email: nkjaha@ucdavis.edu

Study Title: REPLACE: A prospective, randomized, international, multicenter, double-arm, controlled, open label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal.

• Study Type:A Phase IV drug study 
• Purpose: The purpose of this research is to study the investigational drug bardoxolone methyl in patients with connective tissue disease-associated pulmonary arterial hypertension
• More information: clinicaltrials.gov
• Principal Investigator: Roblee Allen, M.D.
• Study contact: 
  • Nikhil Jaha phone: 916-734-1554 email: nkjaha@ucdavis.edu

Study Title: RIN-PH-201: 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 (INCREASE) 

• Study Type:A Phase II/III drug study 
• Purpose: The purpose of this research is to study the investigational drug inhaled treprostinil in patients who have pulmonary hypertension due to parenchymal lung disease
• More information: clinicaltrials.gov
• Principal Investigator: Roblee Allen, M.D.
• Study contact: 
  • Nikhil Jaha phone: 916-734-1554 email: nkjaha@ucdavis.edu

Study Title: PULSE-PHPF-001: A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Clinical Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) in Subjects with Pulmonary Hypertension Associated with Pulmonary Fibrosis on Long Term Oxygen Therapy

• Study Type:A Phase II drug study 
• Purpose: The purpose of this research is to study the investigational drug inhaled nitric oxide (iNO) in patients on long-term oxygen therapy who have pulmonary fibrosis with or without pulmonary hypertension
• More information: clinicaltrials.gov
• Principal Investigator: Roblee Allen, M.D.
• Study contact: 
  • Nikhil Jaha phone: 916-734-1554 email: nkjaha@ucdavis.edu

Study Title: RIN-PH-201: 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 (INCREASE) 

• Study Type: A Phase II/III drug study 
• Purpose: The purpose of this research is to study the investigational drug Treprostinil in patients who have pulmonary hypertension due to parenchymal lung disease
• More information: clinicaltrials.gov
• Principal Investigator: Roblee Allen, M.D.
• Study contact: Megan Suderow phone: 916-734-1554 email: mlsockolov@ucdavis.edu

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials and observational studies. ClinicalTrials.gov includes both interventional and observational studies.

In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, for example, diet. Clinical trials may compare a new medical approach to a standard one that is already available or to a placebo that contains no active ingredients or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.

Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).

Note: Some people who are not eligible to participate in a clinical trial may be able to get experimental drugs or devices outside of a clinical trial through an Expanded Access Program. See more information on expanded access from the National Library of Medicine.

In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan. Participants may receive interventions, which can include medical products, such as drugs or devices, or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.

Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.

Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, U.S. Department of Defense, and U.S. Department of Veterans Affairs. Physicians, health care providers, and other individuals can also sponsor clinical research.

Clinical studies can take place in many locations, including hospitals, universities, doctors' offices, and community clinics. The location depends on who is conducting the study.

The length of a clinical study varies, depending on what is being studied. Participants are told how long the study will last before enrolling.

In general, clinical studies are designed to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Some common reasons for conducting clinical studies include:

• Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition
• Finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches.
• Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition
• Examining methods for identifying a condition or risk factors for that condition
• Exploring and measuring ways to improve the comfort and quality of life of people with a chronic illness through supportive care

A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions as well as safeguard the health of participants. It contains the following information:

•  The reason for conducting the study
• Who may participate in the study (the eligibility criteria)
• The number of participants needed
• The schedule of tests, procedures, or drugs and their dosages
• The length of the study
• What information will be gathered about the participants

Clinical studies have standards outlining who can participate, called eligibility criteria, which are listed in the protocol. Some research studies seek participants who have the illnesses or conditions that will be studied. Other studies are looking for healthy participants. And some studies are limited to a predetermined group of people who are asked by researchers to enroll.

Eligibility. The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria. These are based on things such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Informed consent is a process in which researchers provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll, or continue to participate, in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before entering a study to show that he or she was given information on risks, potential benefits, and alternatives and understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over. See Questions to Ask a health care provider or researcher about participating in a clinical study.

Institutional review boards. Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of physicians, researchers, and members of the community. Its role is to make sure that the study is ethical and the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other things. The IRB also reviews the informed consent document.

In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards).

Various Federal agencies, including the Office of Human Subjects Research Protection (OHRP) and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.

Typically participants continue to see their usual health care providers while enrolled in a clinical study. While most clinical studies provide participants with medical products or interventions related to the illness or condition being studied, they do not provide extended or complete health care. By having the participant's usual health care provider work with the research team, the participant can make sure that the study protocol will not conflict with other medications or treatments being received.

Participating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions.

Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. Sometimes, the safety and the effectiveness of the experimental approach or use may not be fully known at the time of the trial. Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not. Most trials involve some risk of harm or injury to the participant, although it may not be more than the risks related to routine medical care or disease progression. (For trials approved by IRBs, the IRB has decided that the risks of participation have been minimized and are reasonable in relation to anticipated benefits.) Many trials require participants to undergo additional procedures, tests, and assessments based on the study protocol. These will be described in the informed consent document for a particular trial. A potential participant should also discuss these issues with members of the research team and with his or her usual health care provider.

Anyone interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. The following questions might be helpful during such a discussion. Answers to some of these questions are provided in the informed consent document. Many of these questions are specific to clinical trials, but some also apply to observational studies.

• What is being studied?
• Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
• What are the possible interventions that I might receive during the trial?
• How will it be determined which interventions I receive (for example, by chance)?
• Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?
• How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
• What will I have to do?
• What tests and procedures are involved?
• How often will I have to visit the hospital or clinic?
• Will hospitalization be required?
• How long will the study last?
• Who will pay for my participation?
• Will I be reimbursed for other expenses?
• What type of long-term follow-up care is part of this trial?
• If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
• Will results of the study be provided to me?
• Who will oversee my medical care while I am in the trial?
• What are my options if I am injured during the study?