Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

• Status: Completed
• Trial end date: 2001-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Montelukast

Criteria

Inclusion Criteria:

• Patient has history of physician diagnosed asthma

• Patient is in otherwise good stable health

• Patient is able to chew a tablet

Exclusion Criteria:

• Patient is hospitalized

• Patient and/or parent of guardian intends to move or vacation away from home during the course of the study

• Patient had any major surgical procedure within 4 weeks before the study

• Patient had active sinus disease within 3 weeks before the study

• Patient had required intubation for asthma in the past

• Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study

• Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study