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Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

NCT00641472 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2009-03-25

No results posted yet for this study

Summary

A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.

Conditions

Interventions

DRUG

Budesonide inhalation suspension

0.5mg

DRUG

Montelukast Sodium

4mg or 5mg

Sponsors & Collaborators

Principal Investigators

  • Bertil Andersson · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2005-02-28
Completion
2005-02-28

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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 NCT00641472 on ClinicalTrials.gov