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

Setting: Outpatient (any)

Study Design: Randomized controlled trial (double-blinded)

Allocation: Uncertain

Synopsis: After an active run-in period, adults with mild persistent asthma (i.e., self-treatment with beta agonist more than two days per week, nighttime awakenings related to asthma more than two days per month, or variability in the peak expiratory flow of 20 to 30 percent) were randomized to receive 200 mcg of inhaled budesonide (Pulmicort) 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 (Ventolin). They were followed for one year with a variety of symptom scores and physiologic measures. Of 225 patients, 199 completed the study.

After one 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, no clinically significant difference in the number of courses of budesonide or asthma control scores (0.1 to 0.2 on a six-point scale), and no difference in quality-of-life scores.

Bottom Line: Intermittent therapy, as measured by patient-oriented, clinical outcomes, is as effective as continuous therapy with oral zafirlukast or inhaled budesonide for patients with very mild but persistent asthma. It is important to note that these 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 per kg) if symptoms enter the “red zone,” when breathlessness is present at rest or with activities of daily living. (Level of Evidence: 1b)