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Trials That Matter: Minimizing Treatment of Mild, Persistent Asthma
- Michael A. Grippi, MD; and
- Cynthia Mulrow, MD, MSc, Deputy Editor
- From the Hospital of the University of Pennsylvania and Philadelphia Veterans Affairs Medical Center, Philadelphia, PA 19004, and American College of Physicians, Philadelphia, PA 19106.
Current guidelines for management of mild, persistent asthma recommend inhaled corticosteroids as first-line therapy (1–3). Long-term use of these agents in high doses may cause various adverse effects. Therefore, patients may inquire about, and clinicians should consider, alternative management strategies, including low-dose, once-daily inhaled corticosteroids and oral regimens that do not use corticosteroids. Two recently published trials address such approaches (4, 5).
What Did These Important Trials Show?
The LOCCS (Leukotriene or Corticosteroid or Corticosteroid-Salmeterol) trial involved 500 patients with stable, mild, persistent asthma from 19 centers (4). After receiving open-label inhaled fluticasone propionate (100 µg per puff twice daily) for 4 to 6 weeks, adherent patients were randomly assigned to 1 of the following regimens: continued twice-daily fluticasone, nightly inhaled fluticasone (100 µg) plus salmeterol (50 µg), or nightly oral montelukast (5 or 10 mg). All received placebo inhalers or tablets to mask treatment assignments. The mean age of patients was 31 years; 60% were women, and 35% were African American or Hispanic. Before trial entry, 65% had used short-acting β-agonists more than twice weekly, and 45% had used daily inhaled corticosteroids. The average prebronchodilator FEV1 was 86% of predicted at run-in enrollment and 92% of predicted at randomization. Fewer than 7% of monthly follow-up visits during the 16-week intervention period were missed. Treatment failure was defined as hospitalization or an urgent visit for asthma, use of systemic corticosteroids or need for open-label inhaled corticosteroids, predefined decreases in prebronchodilator FEV1 or morning peak expiratory flow rate, daily use of 10 or more puffs of as-needed (rescue) β-agonist for 2 consecutive days, or study withdrawal due to patient dissatisfaction with treatment or physician concern over safety.
Treatment failure rates for groups receiving twice-daily fluticasone, once-daily fluticasone plus salmeterol, and montelukast were 20.2%, 20.4%, and …
