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Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)

NCT00337675 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1771

Last updated 2024-05-10

Study results available
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Summary

This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).

Conditions

Interventions

DRUG

montelukast sodium

Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.

DRUG

Comparator: Placebo (unspecified)

Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.

DRUG

montelukast sodium

Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.

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 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-08-31
Completion
2009-08-31

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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 NCT00337675 on ClinicalTrials.gov