CLEVELAND: Physicians at University Hospitals (UH) Rainbow Babies and Children's Hospital are participating in two new clinical trials with the national research consortium AsthmaNet. UH Rainbow, one of the 27 clinical sites in the United States, has partnered with University of Pittsburgh Medical Center (through a subcontract with Case Western Reserve University), to collaborate on these studies and future asthma clinical research studies in children and adults.
The first study will focus on new treatments for wheezing in young children who wheeze during colds, while a second will examine if Vitamin D can help adolescents and adults who cannot control their asthma through standard inhaled controller medications.
Looking for the best treatment for wheezing in preschoolers with colds
Preschool aged children often have coughing and/or wheezing leading to visits to the doctor's office, urgent care center, emergency department or even hospitalization.
This study, referred to as APRIL/OCELOT, has two parts. The purpose of the first part of the study is to determine if starting the anti-inflammatory drug azithromycin at the first signs of a cold will prevent the development of significant breathing symptoms such as frequent coughing, trouble breathing, or wheezing. If wheezing does begin, the second part of the study is focused on whether steroids are effective at reducing the severity of the wheezing and other respiratory symptoms.
"When preschool children wheeze with colds, doctors typically treat the wheezing and trouble breathing after it starts with asthma medicines," said Kristie Ross, M.D., a pediatric pulmonologist and one of the clinical researchers at UH Rainbow and an assistant professor of pediatrics at Case Western Reserve University School of Medicine. "This study is examining whether azithromycin can prevent the episodes from happening, and how best to treat wheezing when it does happen. The results from this study may give us insight into how to best treat this very common problem."
UH Rainbow hopes to enroll 30 to 40 children through UH Rainbow pediatric offices. Six hundred children will participate in the nation. The study will be a randomized, double-blind study (the "gold standard" of research studies) meaning that neither the research subjects nor the physicians will know which half of the study group is receiving one of the active treatments and which half is receiving a placebo.
Can Vitamin D help patients with asthma?
UH Rainbow also participating in the VIDA (Vitamin D add-on therapy enhances corticosteroid responsiveness in Asthma) Study. Adolescents and adults ages 18 years of age and older who have been diagnosed with asthma and are non-smokers may be eligible for the study.
The purpose of this study is to learn if taking Vitamin D in addition to an inhaled steroid -- the most effective treatment for asthma available today -- will help prevent worsening asthma symptoms and asthma exacerbations in people who have low Vitamin D levels, estimated to be up to 30 percent of the population.
"Patients who live in urban areas, especially in the northern part of the United States, such as Ohio, tend to be deficient in Vitamin D. We also see higher rates of asthma in urban centers such as Cleveland," said Dr. Ross. "Patients who have low levels of Vitamin D tend to have more severe and harder to control asthma. One reason might be that having low levels of vitamin D make it harder for inhaled steroids to work well. Although we think of vitamin D as an important vitamin for healthy bones, there is increasing evidence that it is also important in the immune system and fighting inflammation."
"Despite how common asthma is, it remains poorly understood and, in many cases, poorly treated," said James Chmiel, M.D., principal investigator for the AsthmaNet site at UH Rainbow and associate professor of pediatrics at Case Western Reserve University School of Medicine. "The possibility that improving treatment may be as easy as taking a vitamin which is activated in the skin by normal exposure to sunlight is exciting."
UH Rainbow will enroll 20 patients; 400 patients will be enrolled nationally. This study will be a double-blind randomized trial in which half patients will receive Vitamin D and the other half will receive a placebo. Neither the patients nor the doctors will know which arm of the study the patients are in.
These studies at UH Rainbow are supported by a grant awarded to the University of Pittsburgh, one of nine centers in the AsthmaNet research program. It is funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health.
For more information on both studies, please call 1-216-286-6566, email AsthmaNet@uhhospitals.org , or visit www.AsthmaNetresearch.net .
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About University Hospitals
University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our health system is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. For more information, go to www.uhhospitals.org