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Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

NCT00289874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2022-02-02

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-07-31
Completion
2007-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00289874 on ClinicalTrials.gov