Montelukast on Airway Inflammation
Information source: Merck
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Drug: MK0476, montelukast sodium / Duration of Treatment: 7 Weeks (Drug); Drug: Comparator: placebo / Duration of Treatment: 4 weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
To evaluate the effects of montelukast on nitric oxide and other inflammatory mediators on
EBC (exhaled breath condensate).
Clinical Details
Official title: Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Level of nitric oxide in EBC(exhaled breath condensate)
Eligibility
Minimum age: 6 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Children 6 to 14 yrs old, step 1 and step 2 GINA (Global INitiative for Asthma)
guidelines exhaled nitric oxide (NO) >20 PPB at visit 2
Exclusion Criteria:
- Patient is hospitalized
- Patient has fev1 < 80% predicted on visit 1
- Patient has 2 or more nighttime awakenings for asthma per week or pef variability 30%
or more
Locations and Contacts
Additional Information
Starting date: November 2005
Ending date: June 2006
Last updated: July 2, 2007
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