Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children
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.
2 other identifiers
interventional
380
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Oct 2002
Typical duration for phase_4 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 18, 2008
CompletedFirst Posted
Study publicly available on registry
March 24, 2008
CompletedMarch 25, 2009
March 1, 2009
2.3 years
March 18, 2008
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids
Each clinic visit
Secondary Outcomes (3)
Incidence and Severity of Adverse Events
Each clinic visit
Time to 1st additional asthma medication measured at 12 weeks and 26 weeks
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
Each clinic visit
Study Arms (2)
1
EXPERIMENTALBudesonide inhalation suspension
2
ACTIVE COMPARATORMontelukast sodium
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bertil Andersson
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 18, 2008
First Posted
March 24, 2008
Study Start
October 1, 2002
Primary Completion
February 1, 2005
Study Completion
February 1, 2005
Last Updated
March 25, 2009
Record last verified: 2009-03