Study Designs

Study III (pooled): Combined from two 12-week, double-blind, placebo-controlled studies of 1,576 nonsmoking asthmatic men and women aged 15 years and older with chronic, persistent daytime symptoms and FEV₁ between 40% and 90% of predicted value. SINGULAIR was given as one 10-mg tablet daily; inhaled β-agonist was permitted as needed. In one of these trials, a non-US formulation of inhaled beclomethesone dipropionate dosed at 200 mcg (2 puffs of 100 mcg ex-value) twice daily with a spacer device was included as an active control.

Study IV: A 12-week, randomized, double-blind, placebo-controlled study of 681 asthmatic patients aged 15 years and older with baseline FEV₁ between 50% and 85% of predicted value and β-agonist reversibility of at least 15% SINGULAIR was given as one 10-mg tablet daily; inhaled β-agonist was permitted as needed.^17,18

Study V: A 4-week, multicenter, randomized, placebo-controlled, parallel-group study of 455 men and women with chronic asthma for at least 1 year, which was also active during the allergy season. Study participants were aged 18 years and older and had FEV₁ 60% or greater of predicted value. The study took place during spring allergy season and consisted of a 1-week, single-blind, placebo run-in period followed by a 3-week, double-blind, efficacy and safety evaluation period. Patients were randomized to receive SINGULAIR 10 mg or placebo once daily at bedtime.¹⁹

Study VI (pooled): Pooled data from two 6-week, double-blind, randomized, placebo- and active-controlled, parallel-group studies of 1,512 asthmatic men and women aged 15 years and older with FEV₁ between 50% and 85% of predicted value. Adult patients with chronic asthma were treated for 6 weeks with either SINGULAIR (10 mg once daily) or inhaled beclomethesone (4 puffs twice daily; total daily dose=336 mcg). Patients were allowed inhaled albuterol as needed throughout the studies.²⁰

*Dose of beclomethasone studied was a low or starting dose (8 puffs per day or 336 mcg/day) and was compared with the recommended dose of SINGULAIR for patients 15 years and older (10 mg/day).²⁰ At the time of the study, the approved daily dose of beclomethasone was 6 to 20 puffs per day, or 252 to 840 mcg/day.

†Asthma attack was defined as any of the following: Emergency department visit; hospital admission; unscheduled office visit; or need for oral corticosteroid.

Study VII: 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 currently used ICSs.^21,22

The open-label extension study lasted approximately 1.5 years. Patients had been randomized at the start of the primary study to receive either SINGULAIR or ICSs during the extension; therefore, patients were not rerandomized at the start of the extension.²¹

Study VIII: A randomized, double-blind, 2-period, crossover, placebo-controlled study of 27 children aged 6 to 14 years with persistent asthma and preexercise FEV₁ 70% or more of predicted value and a decrease of 20% or more after exercise challenge at prestudy visits. Twenty to 24 hours after the drug was administered, and at least 6 hours after the last dose of albuterol, patients exercised on a treadmill for 6 minutes. FEV₁ measurements were taken at least 20 and 5 minutes before exercise and during a period of 1 hour after exercise.^23,24

Prescribing Information  |  Patient Product Information

This site is intended only for healthcare professionals of the United States, its territories, and Puerto Rico. SINGULAIR is a registered trademark of Merck & Co., Inc.

20652370(1)-03/07-SNG

For general information and other services for physicians