COPD clinical trial of mitiperstat now recruiting adults in Oklahoma
Care Access study site among nearly 20 across US, over 100 globally
A Phase 2a clinical trial of AstraZeneca’s experimental therapy mitiperstat is now recruiting adults with moderate to severe chronic obstructive pulmonary disease (COPD) at a study site in Choctaw, Oklahoma.
The Care Access research site is among nearly 20 study centers in the U.S., located across 11 states, for the CRESCENDO trial (NCT05492877) — which overall will involve more than 100 trial sites globally. Some of the sites are not yet recruiting. The Choctaw site is the only one in the state of Oklahoma.
CRESCENDO will enroll up to 406 people with COPD, ages 40 to 80, who have a history of smoking and are at high risk of experiencing exacerbations, or flare-ups of symptoms, despite standard treatment for the chronic disease.
Those interested in learning more about the trial and seeing if they fill the criteria of CRESCENDO or other COPD studies, can visit Case Access’ COPD site.
“We recognize the urgent need to provide better treatment options for individuals living with COPD,” Cary Carpenter, MD, the Care Access lead investigator of the trial’s Choctaw site, said in a company press release. “Our community now has the opportunity to contribute to this crucial research effort, potentially changing the way we approach COPD care.”
COPD clinical trial will test mitiperstat’s ability to prevent disease flares
COPD occurs when a person’s airways gradually become inflamed and damaged, making it, over time, harder to breathe. Patients also may experience periods when symptoms get suddenly worse, known as flare-ups, which reduce quality of life and increase the risk of death.
Treatment for the inflammatory disease typically involves a combination of an inhaled long-acting muscarinic antagonist, or LAMA, and an inhaled long-acting beta-agonist, called LABA, or the LAMA-LABA combo with an inhaled corticosteroid.
LAMAs and LABAs are bronchodilators, a type of medication that relaxes and widens the airways. For their part, corticosteroids have anti-inflammatory and immunosuppressive properties. However, approved medications for COPD often fall short in preventing flare-ups.
Mitiperstat, also known as AZD4831, is a small molecule designed to selectively suppress myeloperoxidase, or MPO, which is a protein found in a type of immune cells called neutrophils. In COPD, lung neutrophils home in to the inflamed airways, where they release MPO and other proteins that contribute to lasting inflammation.
A previous Phase 1 clinical trial (NCT03136991) tested mitiperstat in healthy volunteers. The only relevant side effect at doses from 5 to 45 mg was a generalized skin rash in four of the 13 participants given the two highest doses.
The goal of CRESCENDO is to evaluate how safe mitiperstat is against a placebo in people with COPD. The study also will test how well it works to reduce the frequency of flare-ups and to ease symptoms of COPD. It also will evaluate mitiperstat’s pharmacokinetics, or how the therapy moves into, through, and out of the body.
Multiple trial sites will be located in Florida, North Carolina, and Missouri. In addition to Oklahoma, the states of California, Illinois, Michigan, New York, Ohio, South Carolina, and Texas will each host one study center.
Participants are randomly assigned to receive either mitiperstat or a placebo once daily, orally, for 24 weeks or about six months. The researchers will watch for changes in the time to a first event in a composite measure of exacerbations, called CompEx, that includes clinically relevant deteriorations (diary events) and severe exacerbations.
Secondary measures will include changes in forced expiratory volume in the first second (FEV1), a measure of lung function, following a dose of bronchodilator medication, and patient-reported measures of symptom severity and duration.
CRESCENDO is slated to be completed by the end of the year.
Mitiperstat also is under clinical development for certain types of fatty liver disease and heart failure.