Status:
COMPLETED
Montelukast Back to School Asthma Study (0476-340)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
6-14 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
1162 Patients enrolled
Trial Details
Trial ID
NCT00461032
Start Date
June 1 2006
End Date
November 1 2006
Last Update
February 2 2022
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