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Montelukast for Asthma
Phase 2 & 3
Waitlist Available
Led By Jeffrey Blumer, MD
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
The purpose of this study is to determine if montelukast, in addition to standard treatment is helpful in treating patients ages 6-18 who are in the hospital because of status asthmaticus.
Eligible Conditions
- Asthma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate effectiveness of Montelukast as adjunctive therapy
Secondary outcome measures
Estimate the first dose pharmacokinetic parameter of Montelukast
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: MontelukastActive Control1 Intervention
10mg rapid dissolving granules in sterile water orally once
Group II: Sterile WaterPlacebo Group1 Intervention
Sterile water
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,965 Previous Clinical Trials
2,672,745 Total Patients Enrolled
11 Trials studying Asthma
7,211 Patients Enrolled for Asthma
Pediatric Pharmacology Research Units NetworkNETWORK
6 Previous Clinical Trials
712 Total Patients Enrolled
1 Trials studying Asthma
52 Patients Enrolled for Asthma
Jeffrey Blumer, MDPrincipal InvestigatorPPRU
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