A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease
Status:
Completed
Trial end date:
2002-04-01
Target enrollment:
Participant gender:
Summary
This randomized, double-blind, placebo-controlled trial assessed the efficacy of montelukast
in the treatment of adults ≥50 years of age with persistent asthma and/or COPD. Primary
outcomes included forced expiratory volume in one-second (FEV1) and daytime asthma symptoms
scores. Nocturnal symptoms, asthma control, health-related quality of life, peak flow
measurements, and health care utilization were also assessed as secondary outcomes.
Participants were recruited from the Kaiser Permanente Northwest member population. One
hundred forty-nine subjects were randomized to treatment with montelukast (10 mg per day) or
placebo, and were followed for a six-week period. No differences in lung function measures,
health-related quality of life, health care utilization, and asthma symptom scores were
observed; however, the montelukast group had slightly improved asthma control scores compared
to the placebo group.