Hawkins G, McMahon A, Twaddle S, Wood S, Ford I, Thompson N. Stepping down inhaled corticosteroids in asthma: randomised controlled trial. BMJ 2003; 326:1115–1118.
Sharon See PharmD St. John’s University College of Pharmacy and Allied Health Professions, Jamaica, NY
Susan Rubin, MD Beth Israel Program in Urban Family Health, Phillips Family Practice, New York, NY. srubin@chpnet.org.
BACKGROUND: Asthma management guidelines recommend a reduction in steroid use once control is obtained. While some evidence shows that this approach is effective in mild disease, the approach had not been tested long-term in people with moderate to severe disease.
POPULATION STUDIED: A total of 259 adult participants were recruited from rural and urban general medical practices in Scotland. They had an asthma diagnosis for 1 year or more, and daily treatment with at least 800 μg beclomethasone dipropionate, fluticasone, or budesonide equivalent. Eighty-two percent of patients completed the study.
STUDY DESIGN AND VALIDITY: In this long-term, randomized, double-blind trial, patients received either beclomethasone or fluticasone at the dose used before the study began. After this run-in period, they were randomized to receive either a reduction in their dose of inhaled steroids (step-down) or a sham reduction.
OUTCOMES MEASURED: The primary objective was to compare the rates of asthma exacerbation over 1 year. Other outcomes included the number of general practice visits, hospital admissions, and the proportion of patients receiving a 50% reduction in the dose and health status.
RESULTS: At various points during the study, 84% of the step-down group met adequate control criteria and they were given a reduction in the inhaled steroids. Of that group, 49% of the patients achieved a 50% reduction in their dose while maintaining good asthma control. No significant difference was found in the rate of asthma exacerbation or events between the 2 groups. Thirty-one percent (40 people) in the step-down group and 26% (33 people) in the control group had an exacerbation requiring oral steroids (odds ratio [OR]=1.29; 95% confidence interval [CI], 0.75–2.23; P=.354). Overall, the results showed no significant difference in the annual dose of oral steroids between the groups.
Chronic stable asthma patients who use at least 1000 μg beclomethasone or its equivalent daily may reduce their dose of inhaled corticosteroids by as much as 50% without compromising control of symptoms.