Ovid: Welcome to Ovid

Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: A randomized, double-blind, placebo-controlled trial.
Kavuru, Mani MD a; Melamed, Julian MD b; Gross, Gary MD c; LaForce, Craig MD d; House, Karen MS e; Prillaman, Barbara MS e; Baitinger, Leslie BS e; Woodring, Anita MS e; Shah, Tushar MD e
[Article] Journal of Allergy & Clinical Immunology. 105(6, Part 1):1108-1116, June 2000.

(Format: HTML)

Background: Many patients with persistent asthma need both long-acting bronchodilators and inhaled corticosteroids for optimal asthma control.

Objective: Our purpose was to compare the efficacy and safety of salmeterol 50 [mu]g combined with fluticasone 100 [mu]g (in a combination dry powder product) with that of placebo, fluticasone, or salmeterol alone.

Methods: A 12-week randomized, double-blind, multicenter study was conducted in 356 patients aged 12 years or older with asthma. After a 14-day screening period, patients were randomized to treatment with salmeterol 50 [mu]g combined with fluticasone 100 [mu]g (combination product), salmeterol 50 [mu]g, fluticasone 100 [mu]g, or placebo administered in the Diskus dry powder inhaler (GlaxoWellcome, UK) twice daily.

Results: Mean change in FEV1 at end point was significantly (P <= .003) greater with the combination product (0.51 L) compared with placebo (0.01 L), salmeterol (0.11 L), and flutica-sone (0.28 L). The combination product significantly increased (P <= .013) area under the curve compared with placebo and fluticasone on day 1 and compared with placebo, salmeterol, and fluticasone at week 1 and week 12. Patients in the combination product group were less likely to withdraw from the study because of worsening asthma compared with those in the other groups (P <= .020). The combination product significantly increased (P <= .012) morning PEF (combination, 52.5 L/min; placebo, -23.7 L/min; salmeterol, -1.7 L/min; fluticasone, 17.3 L/min) and evening PEF at end point compared with the other groups. The combination product significantly (P <= .025) reduced symptom scores and albuterol use compared with the other treatments and increased the percentage of nights with no awakenings and the percentage of days with no symptoms compared with placebo and salmeterol. All treatments were equally well tolerated.

Conclusion: Salmeterol 50 [mu]g and fluticasone 100 [mu]g combined in the Diskus powder delivery device offers significant clinical advantages over salmeterol or fluticasone alone at the same doses. (J Allergy Clin Immunol 2000;105:1108-16.)