Not long ago, Julie Frischstein, 49, climbed nine flights of stairs. For many people, this is an ordinary occurrence, but for Julie it was a remarkable achievement. At the age of two, she was diagnosed with asthma so severe that she was hospitalized every two weeks during her childhood, sometimes from Thanksgiving until Christmas. Her disease had a major impact on her life. “When you’re a kid you can’t go on sleepovers because nobody wants to be responsible for you,” she said. “You can’t run, you can’t laugh. It was really hard.”
In 2011, Julie joined a clinical trial to test bronchial thermoplasty (BT) a new procedure that shows promise for the treatment of moderate to severe asthma. For her, the procedure was life-changing. “I’m doing things for the first time in my life that I’ve never done before,” she said.
About 25 million people in the U.S. suffer from asthma. Those with the worst cases face frequent trips to the emergency room or constant shortness of breath that medication can’t always control. Before undergoing BT, Julie tried virtually every available medication but her asthma continued to worsen. Over a four-year span, her pulmonary function test – which measures how well the lungs are working– decreased dramatically. She was so short of breath that she had difficulty walking from her bed to the bathroom. “I thought there were no treatment options left,” said Julie, who is a respiratory therapist, a career that she chose because of her condition.
Julie’s pulmonologist at Stamford Hospital recommended that she enroll in the BT study at the Yale Center for Asthma and Airway Disease (YCAAD), which provides world class medical treatment to adults and teens with difficult to control asthma and has one of the most active clinical trial programs for asthma in the Northeast. For example, YCAAD conducts clinical trials for novel antibody-based drugs, which bind to and block molecular targets in pathways that drive the inflammation that occurs in asthmatic airways. In a study that could lead to a personalized approach to asthma management, Geoffrey Chupp, MD, director of YCAAD, and his team analyzed genes in the sputum and blood of asthma patients and identified three subtypes that predict those at risk of having near-fatal asthma attacks, those with severe symptoms, and those with milder asthma.
At first, Julie didn’t qualify for the BT study because her lung function was too low. Several months later she met the eligibility requirements, but at that point, the study was full. Knowing that BT might benefit Julie and other patients, Dr. Chupp pushed to expand the study and Julie was able to undergo the procedure. “For those with severe asthma, this is a terrific option where medication can fall short,” he said.
BT involves a Food and Drug Administration (FDA)-approved device – the first of its kind – that uses radiofrequency energy to gently heat the airways and decrease the tissue in the lungs that is responsible for bronchoconstriction and asthma attacks. YCAAD is one of 30 centers in the country to test BT in a phase IV clinical trial, which is a trial launched after the FDA has approved a treatment as safe over the long term.
Because BT can initially irritate the lungs, the treatment is performed in three outpatient visits to treat different areas of the lungs about one month apart. Julie was in distress the evening after her first treatment, but was able to speak to a physician on the 24-hour study hotline. After that, she knew to expect inflammation immediately after each treatment. What came as a surprise was how much better she felt after just one treatment.
Before enrolling in the clinical trial, she was using her inhalers every few hours and would get a panic attack if she accidentally left the house without them. Now she goes on hikes, climbs hills, and doesn’t think twice about going out without her inhalers. She has gone from working part-time to working full-time. Whereas she used to depend on her parents to help take care of her, she is now able to help them on the family farm.
For Julie, who had run out of options, participating in clinical research gave her the opportunity to undergo a new treatment that dramatically improved her quality of life. “It was the best thing that ever happened to me,” she said. “I’m so thankful.”