aMulticenter, double-blind, randomized, parallel-group, placebo- and active-controlled study, with a 2-week treatment period, of 831 patients aged 15–85 years with active asthma and a history of seasonal allergic rhinitis. SINGULAIR was given as one 10 mg tablet at bedtime (n=415). A total of 416 patients received placebo.1
bp<0.001 vs. placebo for Daily Rhinitis Symptoms Score and Nighttime Symptoms Score.1
cThe primary endpoint was Daily Rhinitis Symptoms Score. The daily rhinitis score was defined as the mean of 2 components: daytime nasal symptoms score and nighttime symptoms score. Each symptom was individually scored daily by patients using a 4-point diary scale from 0 (no symptoms) to 3 (several). The daytime eye symptoms score was also measured.1 See Study Design N for details.
dThe rhinoconjunctivitis score was defined as the average scores of 7 individual domains: nasal symptoms, eye symptoms, non-nose/eye symptoms, activity, sleep, emotions, and practical problems. Each symptom was individually scored before randomization and at the end of the 2-week treatment period using a 6-point scale.1
ep<0.001
fAsthma control measured by beta2-agonist use and patient and physician global evaluations.1
gCOMPACT=Clinical Outcomes with Montelukast as a Partner Agent for Corticosteroid Therapy.5
hSixteen-week randomized, double-blind, parallel-group study of 889 adult asthmatics who were not optimally controlled on inhaled steroids.5
ip=0.36, for change in morning peak expiratory flow (AM PEF) from baseline for the total group (original cohort).23
jPrimary endpoint was AM PEF.5
kIn an exploratory analysis, 410 patients were classified as having allergic rhinitis if there was a positive patient history and a physician-confirmed diagnosis.23
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In a double-blind study in 831 asthmatic patients,
