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

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Comparator: Placebo; Drug: montelukast sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00968201

0476-072

2009_651

Details and patient eligibility

About

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

Enrollment: 689 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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689 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Montelukast

Treatment:

Drug: montelukast sodium

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo