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Budesonide/Formoterol Added to Inhaled Corticosteroids Improves Midrange Forced Expiratory Volume: Presented at AAAAI By Em Brown WASHINGTON, DC -- March 17, 2009 -- Patients with mild to moderate persistent asthma who are dependent on inhaled corticosteroids (ICS) for disease control show a significant improvement in midrange measurements of expiratory flow when fixed-dose budesonide/formoterol by pressurised metered-dose inhaler is added to their treatment regimen. These results, an analysis of 2 phase 3 studies, were presented here on March 15 at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. David S. Pearlman, MD, Colorado Allergy and Asthma Centers and University of Colorado School of Medicine, Denver, Colorado, conducted the studies with colleagues at his institution and at AstraZeneca, LP, Wilmington, Delaware. The first study enrolled 596 patients aged 12 years or older with moderate to severe asthma receiving maintenance ICS therapy who received a 2-week run-in course of budesonide 80 mcg 2 inhalations twice daily and were then randomised to 1 of 5 regimens: · Budesonide/formoterol 160/4.5 mcg 2 inhalations BID in a single inhaler · Budesonide 160 mcg plus formoterol 4.5 mcg, 2 inhalations BID · Budesonide 160 mcg, 2 inhalations BID · Formoterol 4.5 mcg; 2 inhalations BID · Placebo The second study enrolled 480 patients with mild to moderate asthma aged 12 years or older who underwent a 2-week run-in on placebo and were then randomised to 1 of 4 regimens: · Budesonide/formoterol 80/4.5 mcg 2 inhalations BID in a single inhaler · Budesonide 80 mcg, 2 inhalations BID · Formoterol 4.5 mcg, 2 inhalations BID · Placebo Dr. Pearlman's team assessed mean percentage change from baseline to treatment average in predose FEF25%-75%. In study 1, FEF25%-75% improved 16.3% (+-24.0%) with the budesonide/formoterol combination in a single inhaler. It improved 14.6% (+-25.4%) with budesonide plus formoterol and improved 8.4% (+-28.9%) with budesonide alone, while there were declines of 5.7% (+-24.1%) with formoterol alone and 8.3% (+-34.7%) with placebo. In study 2, improvements in FEF25%-75% were highest with combination budesonide/formoterol in a single inhaler (35.9% +- 45.1%), followed by budesonide alone (27.3% +- 50.5%), formoterol alone (18.3% +- 39.4%) and were lowest with placebo (3.2% +- 37.6%). "This is the first study to suggest that [budesonide/formoterol] enhances midrange expiratory flow rates, suggesting that this medication works in both large airways and small airways," Dr. Pearlman said. "This doesn't change the guidelines or change the building blocks of treatment, but it does show that the entire airway is improved with [budesonide/formoterol]." "The study also shows that FEF25%-75% is a good way to measure airflow in the smaller airways. [Forced expiratory volume in 1 second] is really a measure of airflow in the large airway." "The combination is not yet approved for use in children, but the studies have been done and the [US Food and Drug Administration] is looking at them now," Dr. Pearlman commented. Funding for this study was provided by AstraZeneca. [Presentation title: Predose Forced Expiratory Flow Between 25% and 75% (FEF25%-75%) in Inhaled Corticosteroid (ICS)-Dependent Patients With Mild to Moderate or Moderate to Severe Persistent Asthma Receiving Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI). Abstract 602] E-mail this page to a friend or colleague! To print, use this version