UC Davis Health Clinical Studies

Experimental Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

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RELIANCE is a study comparing two drugs. We are trying to learn which one works better, and is better tolerated in people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung disease. We want to compare these drugs in a real world setting. Today, doctors use both Roflumilast and Azithromycin to treat COPD. Research shows that people who take Roflumilast or Azithromycin go to the hospital less often for COPD attacks. The Food and Drug Administration (FDA) has approved Roflumilast for treating COPD with chronic bronchitis. The FDA has not approved Azithromycin for treating COPD. However, the FDA has approved Azithromycin for treating infections. Doctors are allowed to use Azithromycin to treat other conditions when they think it will help their patients. No studies have compared the two medicines to each other. We want to see if Azithromycin is as good as Roflumilast for preventing COPD attacks and thereby decrease hospital visits. Doctors don’t know which drug works best for whom. There are different types of COPD patients, such as current smokers and past smokers. We want to know if one of these medicines is better for patients who smoke.

Drug study, Phase 3
Any, age 40 years or older

A Study of Renal Anhydramnios Fetal Therapy (repeated infusions of replacement amniotic fluid into the womb)

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This research is being done to test repeated infusions of replacement amniotic fluid into the womb. We hope this can reliably rescue the lung function of fetuses that do not make urine, and as a result, have no amniotic fluid. This condition occurs when the fetus has a severe birth defect called congenital bilateral renal agenesis (CoBRA). It can also be caused by fetal renal failure (FRF). We hope to discover whether this fetal intervention can make early pregnancy renal anhydramnios, called EPRA, reliably survivable after birth. We are also doing this study to better understand what happens to EPRA fetuses in the womb that do not receive therapy. During EPRA, the fetus does not have well-developed or functional kidneys and does not make urine. Fetal urine makes up what we commonly call amniotic fluid. This fluid surrounds the fetus and performs many vital functions. The most important function of amniotic fluid is to allow development of the lungs. In normal fetal life, the fetus gets oxygen and releases carbon dioxide through the placenta. Because gas exchange occurs in the placenta, the lungs do not need to function in the womb. They do need to go through a complex developmental process to be ready to work after birth. This developmental process involves the formation of tiny sacs called alveoli in the lungs. They allow the baby to absorb oxygen from the air it breathes in and expel carbon dioxide from the air it breathes out once born. A critical part of the formation of these alveoli is the fluid that fills the lungs during fetal life. The fluid made by the fetus’s lungs causes the alveoli to stretch and grow. If there is no amniotic fluid in the womb, the lung fluid easily escapes from the lungs and cannot perform its vital function of making the alveoli grow. Normally, the amniotic fluid creates enough pressure in the womb to keep the lung fluid in the lungs. Since the amniotic fluid and the lung fluid connect when the fetus opens its mouth and windpipe, the pressure of the amniotic fluid pushes on the lung fluid. This pressure on the lung fluid must be present for the alveoli to develop correctly. Even if the baby’s lungs work well enough after birth for the baby to survive, the baby will still have no kidneys and need dialysis. A pediatric surgeon will need to place a dialysis catheter into the baby’s abdomen. This will allow fluid and toxins to be removed from the baby as a replacement for kidney function and urination. This process is commonly known as peritoneal dialysis. The baby may also need special assistance with feeding and breathing. All of this requires advanced neonatal care in a neonatal intensive care unit (NICU). It is likely that surviving babies will need to be in the NICU for several months before being able to go home. There are frequent challenges with peritoneal dialysis. This includes infection and dialysis catheter malfunction. Not all babies survive because of complications that can arise from peritoneal dialysis. Additionally, surviving babies will eventually need a kidney transplant to survive long-term. Current survival for infants with complete renal failure who survive to receive a kidney transplant is about 70-80%. Organs can come from either living or deceased donors. They require the baby to take medicine every day to prevent his or her body from rejecting the donated kidney. These babies also have problems with the urinary system that normally drains urine from the kidneys namely the bladder and the urethra. This will become an issue after kidney transplant because the urine will need a place to drain and be expelled. A urologic surgeon will need to be involved to help manage this. He or she may need to make a new bladder out of intestine or do other reconstructive surgery.

Procedure study
Female, age 18 to 60 years old

A Study of Chemoradiation With or Without Experimental Atezolizumab For Limited Stage Small Cell Lung Cancer

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This study is being done to answer the following question: Can we lower the chance of small cell lung cancer growing or spreading by adding an experimental immunotherapy drug (atezolizumab) to the usual treatment for this type of cancer? We are doing this study to find out if this approach is better or worse than the usual approach for your type of cancer. The usual approach is defined as care most people get for small cell lung cancer. The usual approach for patients with limited-stage small cell lung cancer who are not in a study is treatment with chemotherapy and radiation therapy.

Radiation study, Phase [2,3]
Any, age 18 years or older

An Extension Study of Experimental PB1046 in Pulmonary Arterial Hypertension After Completing Study PB1046-PT-CL-0004

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Pulmonary Arterial Hypertension (PAH) greatly increases the workload on the right side of the heart. Over time this may lead to dizziness, difficulty breathing, chronic fatigue and possibly death. There is no cure for PAH at this time. You are invited to be in this study because your doctors have determined that you have PAH and you completed the 0004 study. The purpose of this research is to study an investigational drug called PB1046. The word “investigational” means this drug is still being tested in a research setting and is not approved by the U.S. Food and Drug Administration (FDA). Throughout the remainder of this consent form the investigational drug, PB1046 will be referred to as the “study drug.” The active ingredient in the study drug is a slightly changed form of a protein called vasoactive intestinal peptide (VIP). The VIP protein is normally found in the body. The change made to the natural protein helps to protect the protein from breaking down too quickly. It has been reported in scientific sources that the amount of VIP may be lower in people with Pulmonary Arterial Hypertension (PAH). This study is being done for multiple reasons. One reason is to see how well participants with PAH tolerate the study drug long-term. We will check bloodwork periodically and check for side effects. The study will also see whether your body makes antibodies against the study drug. Antibodies are proteins produced by the body's immune system. They are usually found in the blood to help protect our bodies from harm by finding and destroying invaders, like bacteria and viruses. They can also cause harm when they find other proteins that are not normally in the body like the study drug. These antibodies can make the study drug, or the natural VIP found in our bodies, not work as well or not at all.

Drug study, Phase 2
Any, age 18 to 79 years old

A Study of the Experimental Combination of Osimertinib Plus Savolitinib in Non-Small Cell Lung Cancer (NSCLC)

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You are invited to take part in this research study because you have Non-Small Cell Lung Cancer. The reason for the study is to find a more effective treatment for Non-Small Cell Lung Cancer. Whether you take part or not is completely up to you. This study will test the experimental combination of the approved drug osimertinib (TagrissoTM) and the experimental medication savolitinib. We hope to learn if it will work and be safe when given together for the treatment of Non-Small Cell Lung Cancer. Osimertinib is approved by FDA. Savolitinib is not approved by any health authority. The use of osimertinib with savolitinib is experimental in this study.

Drug study, Phase 2
Any, age 18 to 150 years old