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Title: Twice-Daily Budesonide/Formoterol Appears to Control Asthma Better Than Once-Daily Dosing: Presented at AAAAI
URL: http://www.pslgroup.com/dg/21E93A.htm
Doctor's Guide
March 20, 2008


By Ed Susman

PHILADELPHIA -- March 20, 2008 -- Two doses a day of budesonide/formoterol controlled asthma better in adults and adolescents than a single dose of the combination, delivered by pressurized meter-dose inhalers, according to research presented here at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

Investigators conducted the study of more than 600 patients to determine if a single daily dose -- perhaps even with a higher dose of budesonide -- would be effective for control of asthma symptoms.

However, John J. Oppenheimer, MD, Codirector of Clinical Research, Pulmonary and Allergy Associates, Springfield, New Jersey, said the study showed that the once-daily regimen failed to be as effective as twice-daily therapy. He also determined that the combination product controlled asthma better in these patients than budesonide alone.

In general, asthma control was better maintained with the budesonide/formoterol pressurized metered-dose inhaler once daily (320/9 mcg or 160/9 mcg) and twice daily (320/18 mcg/day) than budesonide once daily alone (320 mcg), said Dr. Oppenheimer in his poster presentation on March 14.

In the randomized, double-blind, 12-week study, Dr. Oppenheimer and colleagues assigned 155 patients to receive budesonide/formoterol by pressurized metered-dose inhaler twice a day (total dose 320/18 mcg/day). A second group of 153 patients received budesonide/formoterol in a once-daily dose of 320/9 mcg. A third arm of the study included 157 patients who took budesonide/formoterol once a day in a 160/9-mcg dose. And a fourth group of 153 patients took budesonide by itself once daily in a dose of 320 mcg.

Over the 12-week study, all the combination treatments were statistically superior to budesonide alone (P < .05), Dr. Oppenheimer reported.

Asthma symptom scores were significantly greater (P < .01) with budesonide/formoterol twice daily (320/18 mcg/day) than in either once-daily budesonide/formoterol group for daytime asthma score symptoms, measured during the last 12 hours of the dosing interval, he said.

Both patient groups randomized to once-daily budesonide/formoterol appeared to have similar asthma control.

Patients receiving the twice-daily dosing of budesonide/formoterol appeared to have significantly (P < .05) less need of rescue medicine than any other groups, Dr. Oppenheimer said.

Funding for this study was provided by AstraZeneca.


[Presentation title: Asthma Control With Once-Daily Budesonide/Formoterol Pressurized Metered-Dose Inhaler (pMDI) in Adults and Adolescents With Asthma Previously Stable With Twice-Daily Budesonide/Formoterol pMDI. Abstract 30]

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