SYMBICORT Improved Lung Function In COPD Patients

Ruzanna Harutyunyan's picture
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Data presented today from two pivotal efficacy and safety trials, SHINE and SUN, demonstrated that SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol significantly improved lung function and was well-tolerated in patients with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) relative to budesonide and formotorol administered alone, and placebo.(1,2,3,4) Both trials showed safety profiles consistent with the established profiles in asthma for each product.(2,4) In addition, an analysis of these trials showed that patients receiving SYMBICORT achieved a bronchodilatory effect, or opening of the airways, similar to formoterol DPI, and a more rapid effect than that achieved by either budesonide pMDI or placebo.(5) Results were presented today at CHEST 2008, the 74th annual international scientific assembly of the American College of Chest Physicians, held in Philadelphia, October 25-30, 2008.

In April 2008, AstraZeneca submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for SYMBICORT for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. SYMBICORT is a combination therapy currently indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.(6) SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma.(6)

"Results of the SHINE and SUN trials demonstrated that SYMBICORT improved lung function and was well-tolerated by study patients with COPD,(1,2,3,4) and if approved by the FDA, it could offer a new treatment option for the millions of Americans suffering from this debilitating disease," said lead investigator Donald Tashkin, M.D., of the University of California, Los Angeles (UCLA). "Data from these trials also showed that a greater percentage of patients achieved a 15 percent improvement in FEV1 within 15 minutes with SYMBICORT as compared to budesonide and placebo on the day of randomization and end of treatment."(5)

SHINE Study Results (Abstracts 298 and SHINE Safety)

The efficacy and tolerability of SYMBICORT was assessed in a six-month, randomized, double-blind, multicenter trial evaluating 1,704 patients ages 40 years and older with moderate to very severe COPD.(1,2) After two weeks of treatment based on previous therapy (inhaled corticosteroids (ICS) and short-acting bronchodilators were allowed), patients were then randomized to receive twice-daily treatment with two inhalations of SYMBICORT pMDI 160/4.5 micrograms (mcg), SYMBICORT pMDI 80/4.5 mcg, budesonide pMDI 160 mcg + formoterol DPI 4.5 mcg, budesonide pMDI 160 mcg, formoterol DPI 4.5 mcg or placebo.(1,2) Study results include:

-- Both SYMBICORT doses (160/4.5 and 80/4.5 mcg) demonstrated a significantly greater improvement from baseline in pre-dose forced expiratory volume in one second (FEV1) (P Less Than or Equal To .001) and one-hour post-dose FEV1 compared with budesonide (P<.001).(1)

-- SYMBICORT 160/4.5 mcg also demonstrated a significant (P=.026) improvement from baseline for pre-dose FEV1 compared with formoterol.(1)

-- Improvements from baseline in morning and evening peak expiratory flow (PEF) were significantly (P Less Than or Equal To .016) greater for both SYMBICORT doses compared with formoterol, budesonide and placebo.(1)

-- Both SYMBICORT doses significantly (P<.028) improved the sum of Breathlessness, Cough and Sputum Scores (BCSS), sleep score, awakening-free nights, and rescue medication use versus placebo.(1)

-- Both doses of SYMBICORT were well-tolerated for six months relative to its monocomponents and placebo.(2) The incidence of pneumonia-related adverse events were similar for all treatment arms compared to placebo.(2)

-- The incidence of other potential lung infections (e.g., bronchitis) was generally higher for all active treatment groups, except SYMBICORT 80/4.5 mcg, compared to placebo.(2)

-- The most common drug-related adverse events were oral candidiasis, dysphonia, a voice disorder,(7) and headache.(2)

SUN Study Results (Abstracts 303 and 308)

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The long-term efficacy and tolerability of SYMBICORT was assessed in a 12-month, randomized, double-blind, multicenter study evaluating 1,964 patients ages 40 years and older with moderate to very severe COPD.(3,4) After two weeks of treatment based on previous therapy (ICS and short-acting bronchodilators were allowed), patients were then randomized to receive twice-daily treatment with two inhalations of SYMBICORT pMDI 160/4.5 mcg, SYMBICORT pMDI 80/4.5 mcg, formoterol DPI 4.5 mcg or placebo.(3,4) Study results include:

-- SYMBICORT 160/4.5 mcg demonstrated significantly (P Less Than or Equal To .023) greater improvements from baseline in pre-dose FEV1 and one-hour post-dose FEV1 compared with formoterol.(3)

-- Improvements from baseline in morning and evening PEF were significantly (P Less Than or Equal To .017) greater for both SYMBICORT doses compared with formoterol and placebo.(3)

-- Exacerbation rates were significantly (P Less Than or Equal To .004) reduced by approximately 25-30 percent with both doses of SYMBICORT compared to formoterol and by approximately 40 percent compared to placebo.(3)

-- Both SYMBICORT doses demonstrated significantly (P<.038) greater improvements in BCSS (160/4.5 mcg only), sleep score, awakening-free nights (80/4.5 mcg only), and rescue medication use versus formoterol.(3)

-- Both doses of SYMBICORT were well-tolerated versus formoterol and placebo for up to 12 months.(4) The incidence of pneumonia-related adverse events were similar for all treatment arms compared to placebo.(4)

-- The incidence of other potential lung infections (e.g., bronchitis) was slightly higher in the active treatment groups compared to placebo.(4)

-- The most common drug-related adverse events were oral candidiasis, dysphonia and muscle spasms.(4)

Onset of Bronchodilation Results (Abstract 302)

An analysis of the data from the SHINE (Study I) and SUN (Study II) trials assessed the onset of bronchodilation, defined as the time to achieve 15 percent or greater improvement in FEV1, within the 1,109 study participants ages 40 years and older with moderate to very severe COPD for six and 12 months, respectively.(5) Study results include:

-- Onset of bronchodilation was significantly (P<.001; Wilcoxon rank sum test) earlier for patients receiving both doses of SYMBICORT (160/4.5 and 80/4.5 mcg) and formoterol compared with placebo in both studies.(5) Onset also was significantly earlier for both doses of SYMBICORT versus budesonide (assessed in Study I only).(5)

-- Median time (minutes) to 15 percent FEV1 improvement was as follows: SYMBICORT 160/4.5 mcg (6.8 [I]; 4.2 [II]), SYMBICORT 80/4.5 mcg (4.9 [I]; 4.8 [II]) and formoterol (9.0 [I]; 6.0 [II]).(5)

-- The percentages of patients achieving Greater Than or Equal To 15 percent FEV1 improvement within 15 minutes post-dose were as follows: SYMBICORT 160/4.5 mcg (58.6% [I]; 72.7% [II]), SYMBICORT 80/4.5 mcg (60.8% [I]; 70.2% [II]), budesonide (19.8% [I]), formoterol (61.5% [I]; 60.5% [II]), and placebo (13.0% [I]; 13.6% [II]).(5)

-- Compared with the day of randomization, the median time to onset of bronchodilation for SYMBICORT was maintained at treatment end in both studies, but increased in the formoterol group.(5)

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I FEEL LIKE I CAN RUN 2 HOURS NOW. WORK OUT LONGER. IS THIS IN MY HEAD OR WHAT?