Accolate

* Clinical Question

Does continuous therapy with anti-inflammatory drugs improve outcomes for patients with mild persistent asthma?

Study Design Randomized controlled trial (double-blinded)

Allocation Uncertain

Setting Outpatient (any)

Synopsis One of the things for which primary care physicians are frequently criticized is a failure to treat asthma patients as intensively as is recommended by some guidelines. For example, adults with mild persistent asthma (defined as self-treatment with beta-agonist more than 2 days per week, nighttime awakenings related to asthma more than 2 days per month, or variability in the peak expiratory flow of 20% to 30%) should be taking chronic anti-inflammatory medications based on current National Heart, Lung, and Blood Institute guidelines. Or should they?

After an active run-in period, adults with this severity of asthma were randomized (allocation uncertain) to receive either 200 [micro]g of inhaled budesonide (Pulmi-cort) twice daily, 20 mg of oral zafirlukast (Accolate) twice daily, or matching placebo. All groups could use rescue therapy with budesonide, as needed, according to a symptom guide, as well as inhaled albuterol (Salbutamol). They were followed-up for 1 year with a variety of symptoms scores and physiologic measures. Follow-up was good, with 199 of 225 patients completing the study.

After 1 year, patients in the placebo group (intermittent therapy only) performed slightly worse on a number of outcome measures, such as exhaled nitric oxide levels and the percentage of eosinophils in the sputum. There was no difference regarding the primary outcome of morning peak expiratory flow. If you understand the difference between patient- and disease-oriented outcomes, you should say to yourself, "Who cares?" More important, there was no clinically significant difference in the number of courses of budesonide or asthma control scores (0.1 to 0.2 on a 6-point scale), and no difference in quality-of-life scores.

Bottom Line

Intermittent therapy, as measured by the outcomes that matter, is as effective as continuous therapy with oral zafirlukast or inhaled budesonide for patients with very mild but persistent asthma. Note that patients had a clear plan of action for when symptoms flared up: Begin inhaled budesonide in the "yellow zone," when symptoms initially worsen, and add prednisone 0.5 mg/kg if symptoms enter the "red zone," when breathlessness is present at rest or with activities of daily living. (LOE=1b)

FAST TRACK

Make sue patients have a clear plan of action to deal with worsening symptons

Boushey HA, Sorkness CA, King TS, et al, for the National Heart, Lung, and Blood Institute's Asthma Clinical Research Network. Daily versus as-needed corticosteroids for mild persistent asthma. N Engl J Med 2005; 352:1519-1528.

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