Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

March 24, 2009 updated by: AstraZeneca

An Evaluation of the Effectiveness of Pulmicort Respules (Budesonide Inhalation Suspension) Versus SINGULAIR (Montelukast Sodium) in Children 2-8 Years Old With Asthma Requiring Controller Therapy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

380

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 2 to 8 at study entry
  • At least 3 episodes of wheezing in the previous year that lasted more than 24 hours and affected sleep or symptoms of mild persistent asthma
  • use of b-2 agonist treatment on at least 3 of 7 consecutive days or run in

Exclusion Criteria:

  • Severe or unstable asthma
  • any significant finding at a physical exam
  • an exacerbation of asthma in the 30 days before entering the study that might affect study results in judgement of the study doctor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Budesonide inhalation suspension
Drug: Budesonide inhalation suspension
0.5mg
Other Names:
  • Pulmicort Respules
Active Comparator: 2
Montelukast sodium
Drug: Montelukast Sodium
4mg or 5mg
Other Names:
  • SINGULAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids
Time Frame: Each clinic visit
Each clinic visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and Severity of Adverse Events
Time Frame: Each clinic visit
Each clinic visit
Time to 1st additional asthma medication measured at 12 weeks and 26 weeks
Time Frame: Each clinic visit
Each clinic visit
Time to 1st acute severe exacerbation (as measured by the need for oral steroids), measured at 12 weeks, 26 weeks, and 52 weeks
Time Frame: Each clinic visit
Each clinic visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DX-RES-2103
  • D5257L00750

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe