A Phase 4 interventional study of Budesonide inhalation suspension and Montelukast Sodium in Asthma, sponsored by AstraZeneca. Completed. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2009-03-25.
Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 380 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Budesonide inhalation suspension
Drug: Budesonide inhalation suspension
Montelukast sodium
Drug: Montelukast Sodium
0.5mg
Also known as: Pulmicort Respules
4mg or 5mg
Also known as: SINGULAR
Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids
Time frame: Each clinic visit
Incidence and Severity of Adverse Events
Time frame: Each clinic visit
Time to 1st additional asthma medication measured at 12 weeks and 26 weeks
Time frame: 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
No study locations are listed for this record.
This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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