A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma

NCT00540839 Phase 3 WITHDRAWN

A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma. This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.

Details

Lead sponsor	Organon and Co
Phase	Phase 3
Status	WITHDRAWN
Start date	2007-11

Conditions

• Asthma, Bronchial

Interventions

• Montelukast sodium
• Placebo to montelukast
• Fluticasone propionate
• Placebo to fluticasone

Primary outcomes

• Percentage of days without asthma — 24 weeks
  A day without asthma is defined as a day with all of the following: no daytime symptoms, no nighttime cough, no β-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma \[other than a scheduled visit to a doctor\], or treatment with systemic corticosteroid during the previous 24 hours).
• Number of participants who experience at least one adverse event (AE) — Up to 26 weeks
• Number of participants who discontinue study drug due to an AE — Up to 24 weeks