SYMBICORT trial shows improved quality of life with asthma

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Reviewed

May 24 2007

New data demonstrated that the combination asthma therapy, SYMBICORT (budesonide/formoterol fumarate dihydrate), led to significant improvements in health-related quality of life (HRQL) and greater patient-reported satisfaction with asthma treatment, versus its monocomponents (budesonide or formoterol) or placebo.

The results from these two 12-week randomized, double-blind trials were presented at the American Thoracic Society (ATS) 2007 International Conference held in San Francisco, May 18-23.

"Asthma is a chronic disease that can have a significant effect on patients' day-to-day routine, including participating in activities, such as walking to the store or even playing with their children," said Dr. Kevin R. Murphy, Clinical Professor, University of Nebraska Medical Center. "For the millions of asthma sufferers in the U.S., and especially for those whose condition is not adequately controlled with their current medication, SYMBICORT will provide a new option for patients to help manage and control their asthma, allowing them to get back to their daily activities."

SYMBICORT is a recently approved, combination therapy indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older. SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma. Studies of patients treated with SYMBICORT demonstrated clinically significant improvement in lung function occurring within 15 minutes of beginning treatment. SYMBICORT has safety data in long-term studies of up to one year, and has a robust cardiac safety profile.

"The studies presented at this year's ATS conference provided valuable data on asthma control and asthma-related quality of life with SYMBICORT," said Chris O'Brien, Senior Director, Medical Science, AstraZeneca. "Asthma sufferers will have a new, rapid-acting combination treatment to help them achieve asthma control."

Administered twice daily, SYMBICORT is a combination of two proven asthma medications budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta agonist (LABA). SYMBICORT is approved in the U.S. in two dose strengths, 80/4.5 and 160/4.5 g of budesonide and formoterol, respectively, for patients whose disease is not adequately controlled on other asthma-controller medications or whose disease severity clearly warrants initiation of treatment with two maintenance therapies.

HRQL and Patient Satisfaction Study Results

Abstract #954448: This 12-week, randomized, double-blind, placebo-controlled, multicenter study measured HRQL in 553 patients with moderate-to-severe persistent asthma treated with one of five therapies: Two inhalations with SYMBICORT in one pressurized meter-dose inhaler (pMDI) 160/4.5 micrograms (mcg); budesonide pMDI 160 mcg; formoterol via dry-powder inhaler (DPI) 4.5 mcg; budesonide pMDI 160 mcg + formoterol DPI 4.5 mcg in separate inhalers; or placebo, each bid. HRQL was assessed using the standardized Asthma Quality of Life Questionnaire [AQLQ(S)] a validated survey that measures how asthma affects a person's daily activities, emotional functioning, and symptoms and using patient and physician global assessments.

Results showed that SYMBICORT led to statistically significant and clinically meaningful improvements in AQLQ(S) scores versus formoterol DPI or placebo. SYMBICORT also significantly improved AQLQ(S) scores, compared with budesonide pMDI on all measures except for emotional function. Patient- and physician-reported global assessments showed that a significantly higher percentage of SYMBICORT patients experienced health improvements and managed asthma symptoms better than placebo and budesonide alone, but not formoterol alone.

Abstract #954575: This 12-week, randomized, double-blind, placebo-controlled, multicenter study measured satisfaction to treatment in 390 patients with mild-to-moderate asthma previously treated with inhaled corticosteroids. Patients were randomized to receive treatment with two inhalations with SYMBICORT 80/4.5 mcg, budesonide pMDI 80 mcg, formoterol DPI 4.5 mcg, or placebo, each bid. Patient satisfaction was assessed using three indices of the Patient Satisfaction with Asthma Medication (PSAM) questionnaire, which measures relief of symptoms, perception of medication, and comparison with other medications based on a score of 1 (lowest) to 100 (highest).

Overall, SYMBICORT resulted in significantly higher satisfaction scores on all domains compared with the other treatment groups, including: