Budesonide and Formoterol Combination Has Similar Safety to

Budesonide and Formoterol Combination Has Similar Safety to Separate Components: Presented at AAAAI

By Paula Moyer



SAN DIEGO, CA -- March 2, 2007 -- Combined administration of budesonide
and formoterol in a pressurised metered dose inhaler (Symbicort)
appears to be as safe for people with moderate to severe asthma as is
each of the components taken separately (Pulmicort and Foradil,
respectively).



"This treatment is well tolerated in people 12 years old and over,"
said principal investigator Lanny J. Rosenwasser, MD, Dee
Lyons/Missouri endowed chair in paediatric immunology research,
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United
States. "No clinically meaningful differences in vital signs or
physical examination were observed among the treatment groups."



Dr. Rosenwasser presented these findings from a 12-week, double-blind,
double-dummy, placebo-controlled, multicentre study here on February
24th at the 2007 American Academy of Allergy, Asthma, and Immunology
(AAAAI) annual meeting.



The study enrolled 596 patients who were at least 12 years old, had
moderate to severe asthma, and had been previously treated with inhaled
corticosteroids. They underwent a 2-week run-in period in which they
received 2 inhalations daily of 80 mcg of budesonide in a pressurised
metered dose inhaler.



Patients were then randomised to receive 2 treatments twice daily of 1 of the following regimens:



· budesonide at 160 mcg and formoterol at 4.5 mcg in a pressurised metered dose inhaler;

· budesonide at 160 mcg in a pressurised metered dose inhaler and formoterol at 4.5 mcg in a dry powder inhaler;

· budesonide alone in the same dose and delivery device;

· formoterol alone at the same dose in a dry powder inhaler;

· placebo.



The investigators monitored several safety variables, such as adverse
events, and used postdose electrocardiograms (ECG) and laboratory
evaluations, 24-hour Holter monitor assessments, vital signs, and
physical examinations.



Adverse events occurred in 61.3% of patients on the drug combination in
a metered dose inhaler, 63.5% of those on the combination in separate
delivery devices, 58.7% of those on budesonide alone, 62.6% of those on
formoterol alone, and 43.2% of those on placebo.



Adverse events that the investigators considered to be
treatment-related occurred in 12.9% of those on the combination in a
metered dose inhaler, 8.7% of those on the combination in separate
delivery devices, 5.5% of those on budesonide alone, 7.3% of those on
formoterol alone, and 5.6% of patients of those on placebo.



The investigators noted that the most common treatment-related adverse
events were asthma (0-1.6% across treatment groups), cough (0-1.6%),
throat irritation (0-1.6%), headache/ tremor (0-1.7%), oral candidiasis
(0-3.2%), and chest discomfort (0-0.8%). They documented no clinically
relevant differences in ECG and laboratory values, Holter monitor
assessments, vital signs, and physical examination results.



Symbicort has been approved for long-term maintenance treatment of
asthma in patients 12 years and older who are candidates for
combination therapy, and is expected to be available in the US in
mid-2007, according to Chris O'Brien, MD, senior director, medical
science division, AstraZeneca, which manufactures Symbicort and funded
the study.





[Presentation title: Safety of Budesonide and Formoterol Administered
Via One Pressurized Metered-dose Inhaler (Budesonide/Formoterol pMDI)
in Patients (Greater than or Equal to12 Years) With Moderate to Severe
Persistent Asthma. Abstract 17]