Pediatric Allergic Asthma Study
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: montelukast sodium (Drug); Comparator: Placebo (unspecified) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma
which is also active during allergy seasons in pediatric patients with seasonal aeroallergen
sensitivity.
Clinical Details
Official title: A Multicenter, Double-Blind, Placebo Controlled,Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroallergen Sensitivity
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Percent change from baseline in Forced Expiratory Volume in 1 minute (FEV1)
Secondary outcome: Percent change from baseline in mean daily "as needed" rescue medication use
Eligibility
Minimum age: 6 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female patients, ages 6 to 14 years, with persistent asthma that is also
active during allergy season. Patients must demonstrate positive skin prick tests to
seasonally relevant geographic aeroallergens
Exclusion Criteria:
- Patient cannot have any other acute or chronic pulmonary disorder
Locations and Contacts
Additional Information
Starting date: March 2006
Ending date: August 2007
Last updated: February 12, 2008
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