Montelukast in Mild Asthmatic Children With Allergic Rhinitis
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; Allergic Rhinitis
Intervention: MK0476, montelukast sodium / Duration of Treatment: 12 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The purpose of this study is to assess real-world effectiveness of montelukast in children (2
to 14 years) with asthma and allergic rhinitis.
Clinical Details
Official title: Korean Study of "Real-World" Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Daytime asthma symptom score
Eligibility
Minimum age: 2 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Between 2 and 14 years old
- Diagnosed with asthma, classified as mild persistent asthma according to Global
Initiative Asthma Guidelines (GINA)
- Diagnosed with comorbid allergic rhinitis
Exclusion Criteria:
- Patients with suspected with nasal-sinus infection
- Prior treatment with high dose inhaled corticosteroid requiring a dose higher than
beclomethasone dipropionate 400 ug per day, or equivalent), other medications used in
severe cases.
Locations and Contacts
Additional Information
Starting date: February 2005
Last updated: February 11, 2008
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