Pivotal Data Showed SYMBICORT(R) Improved Lung Function in Adults with COPD
29 Oktober 2008 - 6:00PM
PR Newswire (US)
Data also found SYMBICORT opened airways in less than 15 minutes
WILMINGTON, Del., Oct. 29 /PRNewswire-FirstCall/ -- Data presented
today from two pivotal efficacy and safety trials, SHINE and SUN,
demonstrated that SYMBICORT(R) (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