A new phase 2 clinical trial of multiple therapies for severe asthma is underway in Northeast Ohio, with a focus on personalized therapies based on genetics, family history, lifestyle and environmental factors.
The Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network (PrecISE) study, sponsored by the National Heart, Lung and Blood Institute (NHBLI), is enrolling patients at Cleveland Clinic and University Hospitals Rainbow Babies & Children's Hospital.
The multicenter study involves 30 clinical sites in the United States, Canada and the United Kingdom that will collectively enroll 650 adult and 150 adolescent volunteers, age 12 and over. Prospective participants will be patients with poorly controlled asthma or frequent asthma attacks.
Patients with poorly controlled asthma often experience persistent symptoms, such as wheezing, coughing and shortness of breath, despite high-dose treatments. Severe asthma can impact a patient's quality of life and put them at an increased risk for hospitalizations or even death. An estimated 5-10% of the 25 million Americans living with asthma, suffer from severe forms of the disease, according to the American Lung Association.
Asthma is a complex disease with variable severity and response to treatment. Our aim with this multi-center study is to enhance our ability to individualize treatments to better care for our patients with asthma. If we can better understand individual factors such as how our genes and diet affect asthma, we can more accurately choose treatment or prevention strategies that will work best for each patient."
Serpil Erzurum, M.D., Cleveland Clinic's Chief Research and Academic Officer and Study's Principal Investigator
Cleveland Clinic aims to enroll 35 adult patients and University Hospitals Rainbow Babies & Children's Hospital aims to enroll eight pediatric patients. The UH Rainbow site is led by Kristie Ross, M.D. For more information about participating in this study, please call 216-287-9491 or email [email protected].
The PrecISE study will provide personalized therapies based on each patient's unique genetics, family medical history, lifestyle behavior and environmental factors. This approach, called precision medicine, allows doctors to customize treatments and make adjustments as they assess how well each patient's body responds to them.
After patients are initially enrolled in the study, they will be asked to document their asthma symptoms and undergo tests to help investigators understand their specific type of severe asthma. This information will help guide which treatments patients receive. Adult patients may receive between two and five different treatments throughout the study, while pediatric patients will receive up to three different treatments.
The phase 2, randomized crossover study will evaluate the effectiveness of six experimental therapies to treat severe asthma.These therapies will include medium chain triglyceride supplementation, clazakizumab, broncho-vaxom, imatinib mesylate, cavosonstat and itacitinib.
Dr. Erzurum and the research team have made significant discoveries in studying the link between asthma and metabolism at Cleveland Clinic. In a recent study, the researchers showed that increased resting-energy expenditure in asthma is associated with greater amounts of inflammation. She looks to build upon this research and investigate metabolic interventions for asthma through the PrecISE study.
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