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| |  ACAAI: Singulair (Montelukast) Increases Number of Symptom-Free Days in Young Asthmatic Children By Emma Hitt Special to DG News ORLANDO, FL -- November 20, 2001 -- Singulair (montelukast) appears to increase the percentage of symptom-free days compared to baseline relative to placebo in young children with asthma. Nancy Santanello, MD, MS, a researcher with Merck Research Laboratories, West Point, Pennsylvania, United States, presented the findings yesterday (Nov 19) at the American College of Allergy, Asthma, and Immunology (ACAAI) 47th annual meeting, in Orlando, Florida. The researchers conducted a 12-week, double-blind, randomized, placebo-controlled trial of Singulair, an anti-inflammatory leukotriene receptor antagonist, in 689 two- to five-year-old children with persistent asthma. Findings from the same study focusing on the safety profile of Singulair were published in the September 2001 issue of Pediatrics. According to that analysis, oral Singulair (4 mg chewable tablet) administered once daily in this population was generally well tolerated without clinically important adverse effects. In the current analysis, investigators defined a symptom-free day as a day without any daytime or nighttime symptoms, or a day without any daytime or nighttime symptoms or rescue short-acting beta-agonist use. They then calculated treatment differences (Singulair minus placebo) in median change in percent of symptom-free days from baseline. Dr. Santanello reported that the Singulair group experienced a significantly greater median change in percent of symptom-free days from baseline compared to the placebo group. The number of symptom-free days was reduced by an average of 10 to 15 percent compared to baseline, during which parents of the asthmatic children reported an average of eight symptom-free days out of every 14 days. According to the researchers, the benefit was comparable to the findings of a study in a similar group examining the synthetic corticosteroid Flovent (fluticasone propionate) 100 and 200 µg per day (Glaxo Wellcome, Research Triangle Park, North Carolina, United States). "Small changes in symptoms from placebo are observed in most trials of young children treated with anti-inflammatory therapies," Dr. Santanello noted, "but the number of symptom-free days can provide a useful assessment of asthma control in very young children with persistent asthma," she said. The study was funded by Merck Research Laboratories.
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