MedTrace Logo

Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)

NCT00442559 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2024-05-13

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.

Conditions

Interventions

DRUG

montelukast sodium

Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months

DRUG

inhaled corticosteroid

Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-10-31
Completion
2007-10-31

More Related Trials

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 NCT00442559 on ClinicalTrials.gov