Pediatric Asthma

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Clinical Pediatric and Adolescent Efficacy

In an 8-week study of patients aged 6 to 14 years
SINGULAIR significantly improved an important measure of asthma control 6,7

Graph of Improved Lung Function for Children

Other significant benefits of SINGULAIR for children6

Reduction in days with asthma exacerbations a,b

Percentage of days with asthma exacerbations: SINGULAIR 20.6% (n=197), placebo 25.7% (n=132).

Reduction in ß-agonist useb

Reduction in short-acting ß-agonist use: SINGULAIR 0.56 puffs/day (n=197), placebo 0.23 puffs/day (n=132).

More parents reported on the global evaluation that their child’s asthma was better when taking SINGULAIRb

aAsthma exacerbation defined by specific clinically important decreases in PEFR, increase in ß-agonist use, increase in daytime or nighttime symptoms, or the occurrence of an asthma attack (defined as emergency department visit, hospital admission, unscheduled office visit, or need for oral corticosteroid).

bPercentage of days with asthma exacerbation, SINGULAIR 20.6% vs. placebo 25.7% reduction in short-acting ß-agonist use: SINGULAIR 0.56 puffs per day vs. placebo 0.23 puffs per day; global evaluation scores: SINGULAIR 1.34 vs placebo 1.69.

Study Designs

Study I: An 8-week, randomized, double-blind, placebo-controlled study of 336 children aged 6 to 14 years with baseline FEV1 between 50% and 85% of predicted value. About 36% of patients concurrently used ICSs.6,7

The open-label extension study was an approximately 1.5-year period. Patients had been randomized at the start of the primary study to receive either SINGULAIR or ICSs during the extension; therefore, patients were not randomized at the start of the extension.6

SINGULAIR is indicated for prophylaxis and chronic treatment of asthma in patients aged 12 months and older and for prevention of exercise-induced bronchoconstriction (EIB) in patients aged 15 years and older.

For prevention of EIB, a single dose of SINGULAIR should be taken at least 2 hours before exercise. An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose.

Patients already taking 1 tablet daily for another indication should not take an additional dose to prevent EIB.

SELECTED SAFETY INFORMATION

  • SINGULAIR should not be used as rescue medication to treat acute asthma episodes. Patients should be advised to have appropriate rescue medication available.
  • Neuropsychiatric events have been reported in patients taking SINGULAIR. These events included agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some postmarketing reports appear consistent with a drug-induced effect. Patients should be advised to report any neuropsychiatric events.
  • Use of SINGULAIR may not eliminate the need for inhaled or systemic corticosteroids. Patients should not decrease the dose or stop taking any other antiasthma medications unless instructed by a physician.
  • Safety and effectiveness of SINGULAIR in patients younger than 12 months with asthma have not been established.

Before prescribing SINGULAIR, please read the Prescribing Information.

See all references.

20951836(5)-02/10-SNG

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