Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: July 2007
Intervention(s) in this Clinical Trial
- Drug: montelukast sodium
- montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
- Drug: Comparator: Placebo
- Placebo. Up to 3 weeks of treatment
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- montelukast
- Placebo Comparator: 2
- placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3
- Time Frame: Baseline and week 3
Safety Issue?: No
- Time Frame: Baseline and week 3
Secondary Measures
- Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period
- Time Frame: Baseline and Week 3
Safety Issue?: No
- Time Frame: Baseline and Week 3
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: 14 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Papadopoulos NG, Philip G, Giezek H, Watkins M, Smugar SS, Polos PG. The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity. J Asthma. 2009 May;46(4):413-20.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00289874
Study ID Number: 2006_001
ClinicalTrials.gov Identifier: NCT00289874
Health Authority: United States: Food and Drug Administration
MedWatch - FDA maintained medical product safety Information
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00289874
