With approximately 25 million people in the U.S. suffering from asthma, the University of Kansas Medical Center in Kansas City is helping to make a difference in customizing treatments for patients and also identifying new treatments through a new study sponsored by the National Heart, Lung and Blood Institute.
“The study is called PrecISE and stands for Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network. Precision medicine customizes treatments to patients based on their biomarkers and the PrecISE study allows us to potentially identify new treatments for severe asthma in patients who are currently not controlling their asthma with current FDA approved medications,” Fatima Jackson, clinical research coordinator in pulmonary and critical care, said.
The University of Kansas Medical Center is enrolling participants in the PrecISE study. About 35 other research institutions including 35 U.S. sites are also helping with enrollment, along with a UK site and a Canadian site.
The study’s goal is to use an asthma sufferer’s biomarkers, and testing different treatments for severe asthma, to learn more about new treatments tailored to individuals and their needs.
Participants in the study will:
• Review compliance of home activities
• Questionnaires
• Physical exam
• Randomization
• Blood and urine samples for safety tests and
biomarkers
• Lung function tests
• Your profile collected via blood and a breathing test
• Receive study treatment and details about how to
use the treatment
Severe asthma affects about 5 to 10% of all patients with asthma – about 2.5 million people in the U.S.
“Patients with severe asthma experience substantial morbidity and require extensive use of healthcare resources,” Jackson said. “Despite the use of high-dose inhaled corticosteroids and a second controller (and/or systemic corticosteroids), severe asthma patients continue to have poor control, low lung function and/or increased risk of severe exacerbations.”
The PrecISE Study is unique in that it is an adaptive platform trial conducted under a single Master Protocol to identify new therapies for severe asthma that are effective in biomarker-defined subgroups of participants.
“The trial is designed to meet our primary objectives, namely, to: (1) identify novel therapies that work in biomarker-defined subgroups of participants with severe asthma, and (2) optimize the subgroups targeted for treatment by refining biomarker and subgroups definitions,” Jackson said.
People who are interested in speaking with an asthma specialist and participate in the study will be compensated for their time.
Participants who meet modified guideline criteria for severe asthma and who are currently uncontrolled or continue to have exacerbations will be eligible for the study. Participants must be at least 12 years of age, on a stable regimen of asthma medications prior to enrollment, and satisfy other inclusion/exclusion criteria.
“Eligible participants will start with screening to make sure they are eligible, with a personal profile based on their blood, urine, sputum, and a breathing test is created during the second screening,” Jackson said. “Based on this profile, and once you are confirmed to be eligible, you will be randomly assigned to a treatment (like the flip of a coin).”
Following the initial screening period, participants will be randomly assigned to interventions based on their biomarker profile (biomarkers are bits of information about a person based on the results of different tests such as blood tests, analyses of breath and genetic tests) and enter a two-period, double-blind crossover phase consisting of two 16-week treatment periods separated by a washout period. Treatment sequence will be randomly assigned as either test treatment followed by matching placebo or vice-versa. At the conclusion of the two-period crossover phase and a washout period, it will be approximately 42 months from first participant screened until last participant follow-up.
“By using your biomarkers and testing different treatments, we hope to learn more about treatments tailored to individuals and their needs,” Jackson said.
Out of about 25 million people in the U.S. who have asthma, around 9.8% are female adults, compared to 6.1% of male adults. It is a leading chronic disease in children. Currently, there are about 5.1 million children under the age of 18 with asthma. Asthma rates are highest in Black adults in the U.S.
While most asthma is controlled by currently available therapy including beta-agonists and inhaled corticosteroids, severe asthma continues to produce symptoms and/or exacerbations despite these currently available therapies.
Some patients have a different type of asthma that does not respond to the currently approved treatments, and PrecISE helps to identify new ways to classify and potentially treat these patients.
“Participation in clinical trials is voluntary,” Jackson said. “Our participants want to help us advance the science of medicine, potentially find new treatments for a disease that is affecting them or their loved ones and want to help others.”