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Pulmonary Research and Clinical Trials

UC San Diego Health System physicians design and run clinical trials and research studies with internationally recognized academic researchers and industry sponsors. These trials and studies may offer participants early access to new treatments or treatment strategies. New innovations may be particularly valuable for those who have not responded adequately to conventional treatments.

All participation in a clinical trial or research study is a voluntary, personal decision that should be discussed carefully with a person’s family and medical team. Learn the basics about clinical studies.

Nearly all UC San Diego Health System pulmonologists conduct basic or clinical research. Topics currently under investigation include:
  • Understanding why some people but not others develop sleep apnea
  • Determining physiological mechanisms associated with acclimatization to chronic hypoxia
  • Examining effects of treating sleep apnea in people with Parkinson’s disease
  • Investigating mechanisms of airway remodeling and asthma
  • Identifying cell signaling pathways regulating cardiac hypertrophy, heart failure and vascular disease, including hypertension
  • Developing new diagnostic tests for tuberculosis
  • Understanding the deposition and dispersion of aerosols in the human lung
  • Elucidating the genetic basis and pharmacogenomics of high blood pressure
  • Documenting neuronal excitability and ionic fluxes occurring when neurons lack oxygen
  • Understanding airflow restriction and obstruction among people with lung disease, including asthma and COPD
  • Rehabilitating lung function among people with chronic lung disease
  • Understanding how oxygen is transported from the air to the body's mitochondria, especially in the lungs and the skeletal muscles during exercise
  • Understanding the vascular biology of lung tumor progression
Clinical trials in pulmonary medicine currently recruiting participants in the San Diego region include:

Improving treatment options for patients with obstructive sleep apnea (OSA)

The standard treatment for obstructive sleep apnea is for the afflicted person to wear a continuous positive airway pressure (CPAP) mask while he or she sleeps. The mask blows air into the nose to prevent the person’s throat muscles from relaxing. Though effective, many find the mask uncomfortable and opt against using the treatment. This study investigates whether the antidepressant/sedative trazodone can reduce OSA severity by helping participants sleep more deeply. For more information on the trial, contact Erik Smales, esmales@ucsd.edu, 619-471-9484.

Understanding the impact of a sleep metric on obstructive sleep apnea (OSA)

This clinical trial seeks to determine whether achieving stable ventilation with a person with OSA is affected by his or her “arousal threshold,” a measure of how easily a person wakes up. To test this idea, participants will be given a drug used to treat dementia (called donepezil) before they go to sleep. Physicians will then measure the drug’s effect on arousal threshold and its relationship to OSA severity. The hope is that by manipulating this aspect of sleep, OSA can be more effectively treated. For more information on the trial, contact Erik Smales, esmales@ucsd.edu, 619-471-9484.

Lowering the risk of cardiovascular mortality among patients with obstructive sleep apnea (OSA) and chronic pulmonary disease (COPD)

About 1 percent of the U.S. population has both chronic lung disease and OSA. Although these people are reported to have higher than normal rates of lethal cardiovascular disease, it is not understood why and how the co-occurrence of these conditions conveys higher rates of cardiovascular mortality. This study explores this topic. It will also include a pilot study comparing the effects of nocturnal oxygen therapy alone vs. in combination with a non-invasive face mask ventilator (bi-level positive airway pressure or BiPAP) on heart function and OSA. It is hoped that the concomitant control of normal bloodstream levels of carbon dioxide levels and oxygen will improve heart function in at-risk persons and ultimately lower their chances of cardiovascular-related mortality. For more information on the trial, contact Erik Smales, esmales@ucsd.edu, 619-471-9484.

Personalizing the delivery of oxygen to patients on mechanical ventilators

This is a phase II multi-centered, randomized control trial that tests whether maintaining a minimal but positive trans-pulmonary pressure through a person’s breathing cycle will improve survivorship. The basic idea is that personalizing the volume and rate of delivery of oxygen to an individual will reduce mortality rates among those in critical care. For more information on the trial, contact Jeremy Beitler, jbeitler@ucsd.edu, 646-284-6019.

Improving lung function among patients with emphysema and chronic obstructive pulmonary disease

This is an industry-sponsored, multicenter, randomized control study designed to evaluate whether an IBV Valve System improves lung function. The IBV Valve is a small, umbrella-shaped valve, placed inside the airways of one lung. It is hoped that the valve’s redirection of air from less healthy to more healthy parts of the lung will reduce over-inflation, improving overall lung function among people with emphysema. For more information on the trial, contact Samir Makani, smakani@ucsd.edu, 619-543-5840.

Bronchoscopic lung volume reduction to improve lung function among patients with emphysema

This is an industry-sponsored study designed to test the safety and effectiveness of the Pulmonox Endobronchial Valve (EBV) in treating emphysema. The EBV valve is a one-way valve that blocks off the diseased lung area to inhaled air while allowing trapped air already inside to escape. The valve has not been approved by the FDA and is considered investigational. For more information on the trial, contact Samir Makani, smakani@ucsd.edu, 619-543-5840.

Investigating the efficacy and safety of a new medication for adults with nontuberculosis mycobacterial lung infection (NTM)

This is a randomized, open-label, multicenter study (with more than 100 sites in the United States, Canada, Japan and Australia) to test the efficacy and safety of a medication that has not been approved for use in the treatment of NTM called Liposomal Amikacin for Inhalation (LAI). The goal is to determine whether LAI can treat adults with NTM caused by mycobacterium avium complex who have not responded to previous medications. For more information on the trial, contact Anna Legenkaya, alegenkaya@ucsd.edu.

Collecting cough droplets to detect tuberculosis (TB)

This study examines whether collecting cough droplets with a novel portable, hand-held device could be a replacement for sputum sample collection to detect TB. People suspected of having TB are currently being recruited at Hospital General de Tijuana, and the results from the cough collection sampling are being compared with standard testing on sputum. For more information, contact Wael ElMaraachli, welmaraachli@ucsd.edu, 619-543-3232.

Mindfulness-Based Stress Reduction for Patients with Chronic Lung Disease

This study examines whether mindfulness-based stress reduction (MBSR) techniques can help patients who have chronic lung disease and are often short of breath. The MSBR program under examination consists of eight weekly classes and one day-long training session, at which participants are taught guided meditation, group discussion and techniques to practice at home. The hope is that people who complete the program will experience improved quality of life and better breathing. Eligible participants must be on a stable medical regimen and cannot be experienced in meditation or yoga or have participated in psychotherapy or pulmonary rehabilitation in the last six months. For more information on the study, contact Ni-Cheng Liang, nliang@ucsd.edu and 619-471-9505.

Pulmonary Arterial Hypertension Clinical Trials and Registry Studies

UC San Diego Health System is participating in several ongoing trials and studies to improve the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (CTEPH), both of which are rare diseases. A partial list of these includes:

MERIT-1 and MERIT-2: Macitentan in the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

These two industry-sponsored studies examine the safety and efficiency of the drug macintentan in treating CTEPH among those who are too ill to sustain surgery. For more information on the trials, contact Ileana Rubio, irubio@ucsd.edu, 858-657-7122.

Beraprost-314d added-on to treprostinil

This is an industry-sponsored, multicenter, double-blind, randomized, placebo-controlled Phase 3 study to assess the efficacy and safety of the drug BPS-314d-MR when added to inhaled treprostinil in treating participants with pulmonary arterial hypertension. For more information on the trial, contact Ileana Rubio, irubio@ucsd.edu, 858-657-7122.

U.S. Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Registry

The U.S. CTEPH Registry is a multicenter, observational study of the clinical course and treatment of patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH). The aim of the registry is to promote a greater understanding of the prevalence, pathophysiology, evaluation and treatment of patients with CTEPH through shared information, education and collaborative investigation among pulmonary hypertension centers of excellence throughout the country. For more information on the trial, contact Ileana Rubio, irubio@ucsd.edu, 858-657-7122.

UC San Diego Health System is actively involved in clinical trials of therapeutic agents for treating adult cystic fibrosis. Learn more about ongoing research and clinical trials.

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