Advair Shown Safe for Asthmatic Kids

NEW YORK (Reuters Health) - In children with persistent asthma, twice daily treatment with Advair -- a combination of the corticosteroid fluticasone and the bronchodilator salmeterol -- is well tolerated and has a safety profile similar to fluticasone alone, investigators report.

Dr. Randolph Malone from Southeast Asthma and Allergy Center in Tallahassee, Florida and colleagues say the use of salmeterol with an inhaled corticosteroid "represents a treatment option" for patients who continue to experience asthma symptoms while taking an inhaled corticosteroid.

This approach "minimizes the risk of systemic effects that can occur when either higher doses of inhaled corticosteroids or oral corticosteroids are administered," they write in the Annals of Allergy, Asthma and Immunology.

Last month, an advisory panel to the U.S. Food and Drug Administration unanimously ruled that three bronchodilator asthma drugs -- salmeterol (Serevent), formoterol (Foradil), and fluticasone-salmeterol (Advair) -- are safe enough to stay on the market amid concerns they raise the risk of severe asthma attacks in rare cases.

In their study, Malone's group assigned 203 children 4 to 11 years of age, who experienced persistent asthma during inhaled corticosteroid therapy, to take Advair or fluticasone alone twice daily for 12 weeks.

The children tolerated both treatments well. The most common adverse events included headache, upper respiratory tract infection, throat irritation, gastrointestinal discomfort and pain, nausea and vomiting, and fever. No serious drug-related adverse events were reported in either group.

Two children on Advair and five taking fluticasone withdrew from the study due to worsening asthma.

These results, the authors conclude, demonstrate that twice-daily treatment with fluticasone and salmeterol is as safe as fluticasone alone in children.

SOURCE: Annals of Allergy, Asthma and Immunology, July 2005.