AJAX Study: New Inhaled Medication for Uncontrolled Asthma
Trial Objectives
In severe asthma, some of the exacerbations that cause difficulty breathing are the result of inflammation in the lung. Researchers are testing a class of anti-inflammatory drugs called a JAK1 inhibitor that has worked to treat other inflammatory conditions like eczema to see if it can help people with severe asthma.
In the AJAX study, volunteers will be randomly assigned to receive either a JAK1 inhibitor called AZD4604 or a placebo (a medication containing no active ingredient). Researchers will evaluate if the experimental medication can help improve asthma symptoms, increase airflow and reduce lung inflammation.
At clinic visits, volunteers will receive physical examinations, breathing tests, electrocardiograms (EKGs) and provide blood and urine samples. They will also be asked to complete electronic questionnaires about their symptoms and asthma exacerbations.
Who Can Participate
Participants must have a diagnosis of asthma and be taking a medium or high dose of inhaled corticosteroids with a long-acting bronchodilator medication (such as Symbicort®, ADVAIR®, Breo Ellipta®, Wixela®, Dulera®) for at least the past 3 months. They have to have experienced at least one asthma exacerbation that required systemic steroids (like oral prednisone) in the past year. Participants must be non-smokers and cannot have taken any biologics in the past 6 months.
Age: 18-80 Gender: Any
Estimated Time Commitment
8 visits over 5 months. Visits will last between 1 and 5 hours.
Payment & Reimbursement
Payment: Provided
Travel Reimbursement: Not Available
Trial Location
National Jewish Main Campus, Denver, CO
Trial Sponsors
AstraZeneca
Principal Investigators
Michael E. Wechsler, MD, MMSc
Co-Investigators
Vamsi P. Guntur, MD, MSc