AstraZeneca recently disclosed findings from two studies on its Symbicort (budesonide/formoterol fumarate dehydrate) inhaler formulated for the treatment of adults with chronic obstructive pulmonary disease (COPD) and pediatric patients with asthma. Results from both multi-center international studies revealed that Symbicort is safe and effective overall.
COPD and asthma are two respiratory diseases characterized by difficulties in breathing caused by inflamed lungs airways. Both COPD and asthma are chronic with no current cure. Many marketed drugs are available to relieve the symptoms and lessen opportunities for the conditions to accelerate progression into advanced stages.
When compared to oral drugs, inhaler devices are more efficient because they deliver the drugs directly into and throughout the lungs without passing through the blood stream. Symbicort is an inhalation aerosol indicated for the treatment of COPD and asthma.
The RISE and CHASE Phase 3 studies were devoted to testing the safety and efficacy of Symbicort inhaler in adults with COPD and children with asthma.
COPD Related Study
The Phase 3b Revealing the Impact of Symbicort in reducing Exacerbations in COPD (RISE) study involved 1,219 adults, 40 years of age and older, from more than 200 study sites in 10 countries worldwide. The study aimed to evaluate the impact of Symbicort pressurized metered dose inhaler (pMDI) in decreasing COPD exacerbations in adult patients suffering from moderate to very severe COPD.
Asthma Related Study
The ChildHood Asthma Safety and Efficacy (CHASE) Phase 3 study included 279 children with asthma aged between 6 and 12 years old, from 88 study sites in four countries. The final goal of the study was to test the impact and safety of Symbicort pMDI in comparison with one of its components, budesonide pMDI.
“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. AstraZeneca remains committed to following the science to understand the most optimal approach for using Symbicort and determining the right patient type,” said Greg Keenan, the company’s vice president and head medical officer, U.S. Medical Affairs, in a press release.
Detailed data from both studies will be made available at a later date. Results will also be submitted, in accordance with regulatory requirements, to the FDA and other health authorities.
AstraZeneca is a biopharmaceutical company focused on discovering, developing and commercializing medicines particularly formulated to treat illnesses that fall within three categories: respiratory and autoimmunity; cardiovascular and metabolic diseases; and oncology.