FDA OKs Asthma Drug for COPD

Symbicort Approved to Treat Chronic Obstructive Pulmonary Disease

Medically Reviewed by Louise Chang, MD on March 02, 2009

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 (COPD).

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.