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Department of Internal Medicine

Department of Internal Medicine

Clinical Research in Pulmonary, Critical Care, and Sleep Medicine

Clinical studies help advance patient care through research by evaluating therapies, devices, drugs, diagnostic tools, and patient care practices.

The Division of Pulmonary, Critical Care, and Sleep Medicine conducts clinical trials in conjunction with federal health agencies, various pharmaceutical and device companies, and members of our clinical faculty. Several investigators on our faculty also conduct laboratory research on the UC Davis campus.      

                               patient and doctor

 

Researchers can better understand how to diagnose, treat, and prevent diseases or conditions through different types of clinical studies:

Observational study
A type of study in which people are observed or certain outcomes are measured. No attempt is made by the researcher to affect the outcome — for example, no treatment is given by the researcher.

Clinical trial
During clinical trials, researchers learn if a new test or treatment works and is safe. Treatments studied in clinical trials might be new drugs or new combinations of drugs, new procedures or devices, or new ways to use existing treatments.

Basic Research
These studies may involve the collection of biological samples from volunteers who either suffer from a condition or are healthy.  Study subjects typically do not directly benefit from participation and their medical care is not affected.

Research studies differ from medical care.  When you visit your doctor, he or she diagnoses and treats your current illness or condition. Researchers are trying to gather new knowledge that will help them improve medical care for people in the future by conducting clinical trials.

Active Clinical Trials

If you would like to participate in a study, please contact the research team as listed below.

 

 Acute Lung Injury (ALI)

 

Study Title: (SAILS): Randomized Trial of Rosuvastatin for Acutely Injured Lungs From Sepsis

  • Study Type: A Phase III drug trial
  • Purpose: The objective is to assess the efficacy and safety of oral rosuvastatin in patients with sepsis-induced Acute Lung Injury (ALI).  The hypothesis of this study is that Rosuvastatin therapy will improve mortality in patients with sepsis-induced ALI.
  • More information: clinicaltrials.gov
  • Principal Investigator: Timothy Albertson, MD, PhD
  • Study contact: Ellen Vlastelin          ph: 916-734-3563          pgr: 916-816-5485          email: ellen.vlastelin@ucdmc.ucdavis.edu

 

Study Title: A two part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2586881 in patients with acute lung injury.

  • Study Type: A Phase II drug trial
  • Purpose: The purpose of this study is to investigate the safety of GSK2586881 and to determine what effects it has on people with Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).
  • More information: clinicaltrials.gov
  • Principal Investigator: Timothy Albertson, MD, PhD
  • Study contact: Ellen Vlastelin          ph: 916-734-3563          pgr: 916-816-5485          email: ellen.vlastelin@ucdmc.ucdavis.edu

 

Cystic Fibrosis (CF)

Study Title: (TRANSPORT): A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

  • Study Type: A Phase III drug trial
  • Purpose: The purpose of this study is to evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in persons 12 years and older with Cystic Fibrosis who are homozygous for the F508del mutation. 
  • More information: clinicaltrials.gov
  • Principal Investigator: Brian Morrissey, MD
  • Study contact: Kaitlyn Kirk          ph: 916-734-3351          email: kaitlyn.kirk@ucdmc.ucdavis.edu

 

Chronic Obstructive Pulmonary Disease (COPD)  

Study Title: (RENEW): Lung Volume Reduction Coil Treatment in Patients with Emphysema

  • Study Type: A Phase III device trial
  • Purpose: Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System
  • More information: clinicaltrials.gov; http://www.pneumrx.com/usa/
  • Principal Investigator: Andrew Chan, MD
  • Study contact: Carolyn King          ph: 916-734-3650          email: carolyn.king@ucdmc.ucdavis.edu

 

Study Title: (LIBERATE): Lung Function Improvement after Bronchoscopic Lung Volume Reduction with PulmonX Endobronchial Valves used in Treatment of Emphysema

  • Study Type: A Phase III device trial
  • Purpose: The purpose of this research is to study a medical device that is designed to produce lung volume reduction. This device is called the PulmonX Endobronchial Valve (EBV). It has not been approved by the Food and Drug Administration (FDA) and is considered investigational. The EBV is a one-way valve that blocks off the diseased lung section to inhaled air but lets the trapped air already inside the area escape. With placement of the EBV, the diseased part of the lung collapses which allows the healthier parts of the lung to expand.
  • More information: clinicaltrials.gov; www.pulmonx.com
  • Principal Investigator: Andrew Chan, MD
  • Study contact: Carolyn King          ph: 916-734-3650          email: carolyn.king@ucdmc.ucdavis.edu

 

Study Title: A 52-week, double-blind, randomized, placebo-controlled parallel group study to evaluate the effect of roflumilast 500 mcg on exacerbation rate in subjects with chronic obstructive pulmonary disease (COPD) treated with a fixed dose combination of long-acting beta agonist and inhaled corticosteroid (LABA/ICS)

  • Study Type: A Phase IV device trial
  • Purpose: To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
  • More information: clinicaltrials.gov
  • Principal Investigator: Andrew Chan, MD
  • Study contact: Carolyn King          ph: 916-734-3650          email: carolyn.king@ucdmc.ucdavis.edu

  

Study Title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

  • Study Type: A Phase III drug trial
  • Purpose: This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.
  • More information: clinicaltrials.gov
  • Principal Investigator: Mark Avdalovic, MD
  • Study contact: Kaitlyn Kirk          ph: 916-734-3351          email: kaitlyn.kirk@ucdmc.ucdavis.edu

 

Idiopathic Pulmonary Fibrosis (IPF)  

Study Title: Exhaled Breath Biomarker Signature of Idiopathic Pulmonary Fibrosis: A Case-Control Pilot Study

  • Study Type: Controlled Experiment
  • Purpose: We are looking for volunteers to participate in a clinical research study comparing the breath of people diagnosed with Idiopathic Pulmonary Fibrosis, “IPF,” with people not diagnosed with any lung disease.
  • Principal Investigator: Andrew Chan, MD
  • Study contact: Oanh Nguyen    ph: 916-734-3755      email: oanh.nguyen@ucdmc.ucdavis.edu

 

Study Title: A Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults with Idiopathic Pulmonary Fibrosis

  • Study Type: A Phase II drug trial
  • Purpose: To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.
  • More information: clinicaltrials.gov
  • Principal Investigator: Andrew Chan, MD
  • Study contact: Oanh Nguyen    ph: 916-734-3755      email: oanh.nguyen@ucdmc.ucdavis.edu

 

Study Title: (RAINIER): A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

  • Study Type: A Phase II drug trial
  • Purpose: The purpose of this study is to determine if Simtuzumab (GS-6624) is safe and effective in treating Idiopathic Pulmonary Fibrosis
  • More information: clinicaltrials.gov
  • Principal Investigator: Andrew Chan, MD
  • Study contact: Oanh Nguyen    ph: 916-734-3755      email: oanh.nguyen@ucdmc.ucdavis.edu

  

Pulmonary Arterial Hypertension  (PAH)

Study Title: (AMBITION): A randomized, multicenter study of first-line ambrisentan and tadalafil combination therapy in subjects with pulmonary arterial hypertension

  • Study Type: A Phase III drug trial
  • Purpose: The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.
  • More information: clinicaltrials.gov
  • Principal Investigator: Roblee Allen, MD
  • Study contact: Macey Sockolov    ph: 916-734-1554      email: macey.sockolov@ucdmc.ucdavis.edu

 

Study Title: (ASPIRE): A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated with Tyvaso (treprostinil) Inhalation Solution

  • Study Type: A postmarketing observational study  
  • Purpose: A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies
  • More information: clinicaltrials.gov
  • Principal Investigator: Roblee Allen, MD
  • Study contact: Macey Sockolov    ph: 916-734-1554      email: macey.sockolov@ucdmc.ucdavis.edu

 

Study Title: (PHIANO): A Phase 2, Open-Label, Dose-Escalation Study in Subjects with Pulmonary Arterial Hypertension (PAH, WHO Group 1) and Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis (PH-IPF WHO Group 3) Using Inhaled NITROSYL

  • Study Type: A Phase II drug study 
  • Purpose: A Phase 2 open label, dose escalation study to find the minimally and maximum effective dose (dose beyond which no further effect on PVR is seen) of inhaled nitric oxide generated by the GeNO NITROsyl System compared to placebo.
  • More information: clinicaltrials.gov
  • Principal Investigator: Roblee Allen, MD
  • Study contact: Kirsten Alman    ph: 916-734-1554      email: kirsten.alman@ucdmc.ucdavis.edu

 

Study Title: (TDE-PH-310): A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event Driven Study to Compare the Time to First Clinical Worsening in Subjects with Pulmonary Arterial Hypertension Receiving UT-15C (oral remodulin, a prostacyclin receptor agonist  in Combination with a PDE5-I or ERA Compared with a PDE5-I or ERA Alone

  • Study Type: A Phase III drug study 
  • Purpose: This study is an international, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving PDE-5 inhibitor or ERA for 31 to 90 days prior to randomization for their PAH. Study visits will occur in four week intervals for the first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to first clinical worsening event and the 6-minute walk test at Week 24.
  • More information: clinicaltrials.gov
  • Principal Investigator: Roblee Allen, MD
  • Study contact: Macey Sockolov    ph: 916-734-1554      email: macey.sockolov@ucdmc.ucdavis.edu

 

Study Title: (AIR001-CS05): A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine  the Safety and Efficacy of AIR001 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension

  • Study Type: A Phase II drug study 
  • Purpose: The AIR001-CS05 study evaluated the safety and efficacy (effectiveness) of AIR001 over 16 weeks in subjects who have PAH. The purpose of the AIR001-CS06 study is to evaluate the intermediate / long-term safety of AIR001 in subjects who have completed the AIR001-CS05 study. Assessments to evaluate the effectiveness of the study drug will include measurements of exercise ability and evaluations of PAH disease symptoms.
  • More information: clinicaltrials.gov
  • Principal Investigator: Roblee Allen, MD
  • Study contact: Macey Sockolov    ph: 916-734-1554      email: macey.sockolov@ucdmc.ucdavis.edu

 

Sepsis

 

 

Study Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects With Severe Sepsis and Coagulopathy

  • Study Type: A Phase III drug trial
  • Purpose: The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.
  • More information: clinicaltrials.gov
  • Principal Investigator: Christian Sandrock, MD
  • Study contact: Tina Tham          ph: 916-734-3351          pgr: 916-816-1553          email: tina.tham@ucdmc.ucdavis.edu

 

Study Title: (SAILS): Randomized Trial of Rosuvastatin for Acutely Injured Lungs From Sepsis

  • Study Type: A Phase III drug trial
  • Purpose: The objective is to assess the efficacy and safety of oral rosuvastatin in patients with sepsis-induced Acute Lung Injury (ALI).  The hypothesis of this study is that Rosuvastatin therapy will improve mortality in patients with sepsis-induced ALI.
  • More information: clinicaltrials.gov
  • Principal Investigator: Timothy Albertson, MD
  • Study contact: Ellen Vlastelin          ph: 916-734-3563          pgr: 916-816-5485          email: ellen.vlastelin@ucdmc.ucdavis.edu

Contact Us

The UC Davis Pulmonary, Critical Care, and Sleep Medicine Research Unit consists of faculty and staff members who are engaged in clinical care and clinical research for people with pulmonary disorders, such as acute lung injury (ALI), sepsis, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), and pulmonary arterial hypertension (PAH).  For additional information or questions regarding clinical trials, please feel free to contact any member of our research staff.

Carolyn King
carolyn.king@ucdmc.ucdavis.edu
(916) 734-3351
Pulmonary fibrosis and COPD

Ellen Vlastelin, C.C.R.P
ellen.vlastelin@ucdmc.ucdavis.edu
(916) 734-3563; pgr: (916) 816-5485
Acute lung injury and sepsis

Kaitlin Kirk
kaitlyn.kirk@ucdmc.ucdavis.edu
(916) 734-3351
Cystic fibrosis, bronchiectasis, and COPD

Kirsten Alman
kirsten.alman@ucdmc.ucdavis.edu
(916) 734-1554
Pulmonary hypertension

Leslie Anunciacion, C.C.R.P
leslie.anunciacion@ucdmc.ucdavis.edu
(916) 734-1554
Pulmonary hypertension

Macey Sockolov, C.C.R.P
macey.kelly@ucdmc.ucdavis.edu
(916) 734-1554
Pulmonary hypertension

Maya Juarez, C.C.R.P
maya.juarez@ucdmc.ucdavis.edu
(916) 734-3643
Pulmonary fibrosis and COPD

Oanh Nguyen
oanh.nguyen@ucdmc.ucdavis.edu
(916) 734-3755
Pulmonary fibrosis and COPD

Tina Tham, C.C.R.P
tina.tham@ucdmc.ucdavis.edu
(916) 734-3351; pgr: (916) 816-1553
COPD and sepsis

FAQs

Frequently Asked Questions

 

  • What Is a Clinical Study?
  • Clinical Trials
  • Observational Studies
  • Who Conducts Clinical Studies?
  • Where Are Clinical Studies Conducted?
  • How Long Do Clinical Studies Last?
  • Reasons for Conducting Clinical Studies
  • Participating in Clinical Studies
  • Who Can Participate in a Clinical Study?
  • How Are Participants Protected?
  • Relationship to Usual Health Care
  • Considerations for Participation
  • Questions to Ask

 

What Is a Clinical Study?

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.

 

Clinical Trials

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.

 

Observational Studies

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.

 

Who Conducts Clinical Studies?

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.

 

Where Are Clinical Studies Conducted?

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.

 

How Long Do Clinical Studies Last?

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

 

Reasons for Conducting Clinical Studies

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

 

Participating in Clinical Studies

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

 

Who Can Participate in a Clinical Study?

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.

 

How Are Participants Protected?

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.

 

Relationship to Usual Health Care

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.

 

Considerations for Participation

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.

 

Questions to Ask

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?

 

 

Learn About Clinical Studies (all text in this section from clinicaltrials.gov http://clinicaltrials.gov/ct2/info/understand)

 

Patient Resources

Acute Respiratory Distress Syndrome (ARDS), Acute Lung Injury (ALI), and Sepsis topics       

 

Cystic Fibrosis (CF) topics

  

Chronic Obstructive Pulmonary Disease (COPD) topics

 

Interstitial Lung Disease (ILD) topics

 

Pulmonary Hypertension topics