FDA OKs Asthma Drug for COPD
Symbicort Approved to Treat Chronic Obstructive Pulmonary Disease
March 2, 2009 -- The FDA has approved the use of Symbicort pMDI (pressurized
metered-dose inhaler), which is used to treat asthma, to treat chronic obstructive pulmonary disease
According to AstraZeneca, which makes Symbicort, the FDA approved Symbicort
for COPD based on two clinical trials that included more than 3,600 COPD
patients aged 40 and older.
Symbicort is delivered by an inhaler. Its active ingredients are formoterol
(a long-acting beta agonist) and budesonide (a corticosteroid).
In the clinical trials, COPD patients taking Symbicort had a greater
improvement in their lung function, compared to patients using a placebo,
formoterol, or budesonide.
It typically took five minutes for lung function to start to improve with
Symbicort treatment, and Symbicort was generally well tolerated.
In one of the trials, which lasted for a year, potential lung infections
other than pneumonia were more common
among patients using Symbicort than among those using the placebo or
formoterol. The most common side effects were colds, oral thrush, bronchitis, sinusitis, and viral infections
of the upper respiratory tract.