Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

Asthma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641472
• Other study ID #: DX-RES-2103
• Secondary ID: D5257L00750
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: March 24, 2009
• Start date: October 2002
• Est. completion date: February 2005

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 8 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide inhalation suspension
0.5mg
• Montelukast Sodium
4mg or 5mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids		Each clinic visit
Secondary	Incidence and Severity of Adverse Events		Each clinic visit
Secondary	Time to 1st additional asthma medication measured at 12 weeks and 26 weeks		Each clinic visit
Secondary	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