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Fluticasone/Salmeterol Combination (Seretide) Shows Consistent Benefits Over 12 Weeks: Presented at ERS

By Earl R. Nichols

VIENNA, AUSTRIA -- October 2, 2003 -- Seretide (fixed-combination fluticasone/salmeterol) provides more effective asthma control than daily montelukast monotherapy, according to data from two retrospective 12-week studies presented here September 30^th at the 13^th Annual Meeting of the European Respiratory Society.

Asthma is a highly variable condition, and a patient's symptoms and response to medication can change drastically from week to week, noted lead author David Stempel, MD, University of Washington, Bellevue, Washington, United States. With colleagues, Dr. Stemple therefore designed a study to take into account week-to-week fluctuations in such areas as symptom control, use of rescue medications and number of symptom-free days.

The studies enrolled patients with shortness of breath, tightness in the chest, and wheezing, who had symptom scores of 2 or greater on at least 3 days of the 14 days preceding the start of the trial. Patients had been poorly controlled prior to study entry and were using albuterol as rescue medication a mean of 6.4 times per week.

The researchers randomised 427 patients to treatment with Seretide 100/50 mcg twice daily and 428 to montelukast 10 mg daily.

Success or response was recorded on the basis of the percentage of patients per week who responded throughout each of the 12 weeks in the study.

Patients using the Seretide fared significantly better than those who were using montelukast on virtually all measurements. Seventy percent of Seretide patients and 45% of montelukast patients recorded a greater than 10% improvement in morning forced expiratory volume in one second (FEV₁) measurements during at least half of the weeks of the study. Forty-one percent of the Seretide patients and 14% of the montelukast patients had the same increase in FEV₁ for all of the weeks of the study.

There was also a reduction in the number of times that albuterol was used as rescue medication by patients in the Seretide group during the studies compared to the montelukast group.

Fifty-eight percent of Seretide users and 32% of montelukast users reported at least 2 fewer days per week when they were symptom-free for half of the weeks of the study. Twenty-seven percent and 7% had two or more symptom-free days throughout the entire study respectively.

By the end of Week 12, almost half of the Seretide patients were reporting that they used fewer than 2 puffs of albuterol as rescue medication per week compared with 21% of those in the montelukast group.

Dr. Stemple and colleagues concluded that asthma control means more than just meeting a certain improvement in FEV₁; it also means a reduction in the number of days the patient is symptom free and a reduction in resource use to manage flare-ups of the condition. In all these measurements, the authors concluded, Seretide was significantly superior to montelukast.

The study was funded by GlaxoSmithKline, which makes Seretide.


[Study title: Variability in asthma and treatment efficacy as determined by weekly response rates with fluticasone propionate/salmeterol 100/50mcg (FSC) compared with montelukast 10mg (MON). Abstract 1702]

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