AstraZeneca’s Inhalation Aerosol Shows Promising Data for Pulmonary Disease and Asthma
After AstraZeneca’s failed Phase III trial of the investigational drug, selumetinib for non-small cell lung cancer treatment. AstraZeneca hit the news again with the positive top-line data from two Phase III studies.
Symbicort® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol was well tolerated and demonstrated promising results in two Phase III studies. First, in adult patients with chronic obstructive pulmonary disease (COPD) and another in pediatric patients with asthma.
Figure 1. Symbicort® (budesonide/formoterol fumarate dihydrate) turbuhaler (photo credit: couponcodefordiscount.com).
Phase IIIb study (RISE) was conducted in 1,219 adult patients aged 40 years and older, efficiency of Symbicort pressurized metered dose inhaler (pMDI) (160/4.5 micrograms) and formoterol Turbuhaler (4.5 micrograms) was evaluated which was taken two inhalations, twice daily by the moderate to very severe COPD patients.
Skeletal formulae of budesonide and formoterol
In another Phase III study (CHASE), 273 children of age group 6 to 12 years with asthma were treated with budesonide/formoterol in a pMDI 80/2.25 micrograms, and SYMBICORT pMDI 80/4.5 micrograms, compared with budesonide pMDI 80 micrograms to study its safety and efficiency in pediatric patients when given two inhalations twice daily.
Greg Keenan, Vice President and Head Medical Officer, US Medical Affairs, said: “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”.
The CHASE study results will be further submitted to U.S. Food and Drug Administration (FDA) and other health authorities and the additional regulatory submission will depend on the complete RISE study results.
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