AstraZeneca recently announced positive top-line data from two international, multi-center clinical trials in adult patients with chronic obstructive pulmonary disease (COPD) and in pediatric patients with asthma. The results show that Symbicort inhalation aerosol was well tolerated and achieved primary endpoints in both studies.
Symbicort is a combination of budesonide, a steroid that reduces inflammation in the body, and formoterol, a bronchodilator that relaxes muscles in the airways. The drug is designed to improve breathing.
Symbicort is currently indicated for the treatment of asthma in patients older than 12 years old. Symbicort 160/4.5 is indicated for the maintenance treatment of airflow obstruction in COPD patients, as well as in chronic bronchitis and emphysema patients. Symbicort’s full prescribing information, boxed warning and medication guide has been published.
The Phase 3b RISE (NCT02157935) clinical trial, to study Symbicort for adult moderate to very severe COPD flareups, included 1,219 patients, 40 years old or older, in more than 200 sites throughout 10 countries. The trial compared the efficacy of Symbicort pressurized metered dose inhaler (pMDI) at 160/4.5 micrograms inhaled twice, two times a day, against formoterol Turbuhaler at 4.5 micrograms inhaled twice, two times a day.
The Phase 3 CHASE 3 (NCT02091986) clinical trial, which assessed 279 children with asthma from 6 to 12 years old, from which 273 received treatment, involved 88 study centers in four countries. The trial evaluated the efficacy and safety of Symbicort in a pMDI at 80/2.25 micrograms and Symbicort pMDI at 80/4.5 micrograms against budesonide pMDI at 80 micrograms. All asthmatic children received two inhalations of treatment two times per day.
This trial is part of the CHASE program, made up of three pediatric clinical studies, designed to meet Pediatric Research Equity Act (PREA) requirements, fulfill the terms of a Complete Response Letter issued by the U.S. Food and Drug Administration (FDA), and respond to the agency’s feedback.
“Positive results from the RISE and CHASE 3 studies reinforce Symbicort as an important treatment option for respiratory patients across a broad range of age groups,” said Greg Keenan, the company’s U.S. medical affairs’ vice president and head medical officer, in a press release. “AstraZeneca remains committed to following the science to understand the most optimal approach for using Symbicort and determining the right patient type.”
Detailed data from both studies will be released at a later date. Results will also be submitted to the FDA and other health authorities.