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Combined Budesonide/Formoterol Inhaler Improves Lung Function in Chronic Obstructive Pulmonary Disease: Presented at CHEST By Em Brown PHILADELPHIA -- November 2, 2008 -- Combination therapy with budesonide/formoterol inhalation improves lung function, quality of life, and sleep scores in patients with moderate to severe chronic obstruction pulmonary disease (COPD), according to 2 large placebo-controlled trials presented here at CHEST 2008, the annual meeting of the American College of Chest Physicians (ACCP). Results of the 6-month SHINE and the 12-month SUN trials of budesonide/formoterol with budesonide monotherapy and formoterol monotherapy were presented here on October 29. In the 6-month SHINE study, 1,704 patients aged 40 years and older with moderate to very severe COPD were randomised to 1 of 6 treatments, all twice daily: (1) Two inhalations of budesonide/formoterol metered-dose inhaler (160/4.5 mcg) (2) Two inhalations of combined budesonide/formoterol metered-dose inhaler (80/4.5 mcg) (3) Two inhalations of budesonide (160 mcg) metered-dose inhaler plus 2 inhalations of formoterol dry powder inhaler (4.5 mcg) (4) Two inhalations of budesonide metered-dose inhaler (160 mcg) (5) Two inhalations of formoterol dry powder inhaler (4.5 mcg) (6) Placebo "The higher-dose [combination therapy] met the gold standard of superior efficacy of either component alone," reported principal investigator Donald P. Tashkin, MD, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California. "The lower dose [combination therapy] met the requirement of greater efficacy than budesonide alone." Both doses of the combined budesonide/formoterol metered-dose inhaler (160/4.5 mcg and 80/4.5 mcg) demonstrated a significantly greater improvement from baseline in predose forced expiratory volume in 1 second (FEV1, P <= .001) and 1-hour postdose FEV1 compared with budesonide alone (P < .001). Budesonide/formoterol 160/4.5 mcg demonstrated a significant (P = .026) improvement from baseline for predose FEV1 compared with formoterol. Improvements from baseline in morning and evening peak expiratory flow (PEF) were significantly greater for both doses of combined budesonide/formoterol metered-dose inhaler compared with formoterol alone, budesonide alone, and placebo (P <= .016). Both doses of combined budesonide/formoterol metered-dose inhaler significantly improved the sum of Breathlessness, Cough, and Sputum Scores (BCSS), sleep score, awakening-free nights, and rescue medication use compared with placebo (P <= .028). The 12-month SUN results, involving 1,964 patients with moderate to severe COPD, were similar. Patients were randomised to receive 1 of 4 different twice-daily treatments: 2 inhalations of combined budesonide/formoterol metered-dose inhaler (1 group receiving a high dose of 160/4.5 mcg and 1 group receiving a low dose of 80/4.5 mcg), 2 inhalations of formoterol (4.5 mcg) dry powder inhaler, or placebo. The higher-dose combination therapy demonstrated significantly greater improvements from baseline in predose FEV1 and 1-hour postdose FEV1 compared with formoterol (P <= .023). Both combination doses demonstrated significantly greater improvements from baseline in morning and evening PEF compared with formoterol and placebo (P <= .017). Exacerbation rates were significantly reduced by 25% to 30% with both combination doses compared to formoterol, and by approximately 40% compared with placebo (P <= .004). Combined budesonide/formoterol had significantly greater improvements in BCSS (with the higher dose), sleep score, awakening-free nights (lower dose only), and rescue medication use, compared with formoterol (P < .038). Median time to 15% improvement in FEV1 was 6.8 minutes with the higher dose of combined budesonide/formoterol, 4.9 minutes with the lower dose of combined budesonide/formoterol, and 9.0 minutes with formoterol alone. The percentage of patients achieving a 15% or greater improvement in FEV1 within 15 minutes were 72.7% with the higher dose, 70.2% with the lower dose, 19.8% with budesonide alone, 60.5% with formoterol alone, and in 13.6% of patients receiving placebo. Median time to onset of bronchodilation with budesonide/formoterol combination was maintained throughout the 12-month study period. Both doses of budesonide/formoterol were well tolerated in both trials compared with monotherapy or placebo. The incidence of bronchitis was higher for all active treatment groups except the lowest budesonide/formoterol dose compared with placebo. The most common drug-related adverse events were oral candidiasis, dysphonia, and headache. "The papers have been filed with the [US Food and Drug Administration], and we are expecting approval of the higher dose of budesonide/formoterol for COPD. It is only approved for the treatment of asthma right now," Dr. Tashkin noted. "We've traditionally thought that COPD is an end-stage disease, with treatment geared toward symptom relief," said Ronald Grossman, MD, University of Toronto, Toronto, Ontario, and spokesman for the ACCP. "It turns out that COPD is an active, inflammatory airway disease, so there is something we can do about the disease process itself." "This is what is going to lead to a change in practice in the care of patients with COPD," Dr. Grossman asserted. "This gives us another tool." Funding for this study was provided by AstraZeneca. [Presentation titles: Onset of Bronchodilation With Budesonide and Formoterol Administered in One Pressurized Metered-Dose Inhaler in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease. Abstract AP2236 and Efficacy of Budesonide/Formoterol Administered via One Pressurized Metered-Dose Inhaler Over 6 Months in Patients With Chronic Obstructive Pulmonary Disease. Abstract AP2236] E-mail this page to a friend or colleague! To print, use this version