ACAAI: Combined Salmeterol, Fluticasone Allows Lower Steroid Dose in Asthma Patients

By Roberta Friedman
Special to DG News

SAN ANTONIO, TX -- November 19, 2002 -- Adding salmeterol to fluticasone allows use of a lower dose of inhaled steroid in asthma for some patients, according to finding presented here November 18 at the meeting of the American College of Allergy, Asthma & Immunology (ACAAI).

Patients who required 250 mcg twice daily of fluticasone were able to lower that moderate dose to 100 mcg, by adding 50 mcg of the beta adrenergic drug salmeterol to the inhaled steroid.

The study enrolled 574 qualifying patients in a design that allowed investigators to winnow out those who would not be stable enough to lower the steroid safely.

"This was a difficult trial," admitted investigator Paul Dorinsky, MD, a principal clinical research physician, US Medical Affairs, Respiratory, at Glaxo Wellcome, Research Triangle Park, North Carolina, but the patients "could be safely reduced with this approach." Only one patient did poorly in the test phase of the study but did not require hospitalization, he said.

Dorinsky, who is with Glaxo, but also sees patients at the University of North Carolina in Raleigh, North Carolina, United States, called the reduction achieved in steroid "fairly substantial."

Adding salmeterol, he said, "allows the dose of fluticasone to be dropped 60 percent with comparable or improving level of asthma control."

Patients who required maintenance of a 250 mcg dose twice daily of fluticasone, enrolled in the trial, had to show instability of their asthma control. This was tested during an initial month of the study that lowered the dose to 220 mcg twice daily.

Then the dose was raised back to 250 mcg. If they regained stability, patients were then randomised to continue on this dose, or to start inhaling, twice daily, 100 mcg of fluticasone with 50 mcg of salmeterol from a single inhaler.

The primary efficacy outcome was the proportion of patients who remained stable in the study after 12 weeks and did not drop due to worsening asthma. Fewer patients withdrew due to lack of efficacy in the combination group compared with the group receiving fluticasone alone.

Equivalent measures of forced expiratory lung volume at one second (FEV_I) resulted from both treatments. Percent of symptom free days significantly improved with the combination of inhaled drugs.

Dorinsky noted that pending analysis of anti-inflammatory markers suggests that inflammation is controlled as effectively with the combination as with the higher dose of fluticasone alone.

These doses of steroid and salmeterol are available commercially, Dorinsky said.