Montelukast Back to School Asthma Study (0476-340)

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Comparator: Placebo; Drug: montelukast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00461032

0476-340

MK0476-340

2007_539

Details and patient eligibility

About

This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.

Enrollment: 1,162 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

Exclusion criteria

• Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,162 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

montelukast

Treatment:

Drug: montelukast

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo