Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

Condition(s) targeted: Asthma

Intervention: Budesonide inhalation suspension (Drug); Montelukast Sodium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Bertil Andersson, Study Director, Affiliation: AstraZeneca

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.

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.

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Primary outcome: Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids

Secondary outcome:

Incidence and Severity of Adverse Events

Time to 1st additional asthma medication measured at 12 weeks and 26 weeks

Time to 1st acute severe exacerbation (as measured by the need for oral steroids), measured at 12 weeks, 26 weeks, and 52 weeks

Minimum age: 2 Years. Maximum age: 8 Years. Gender(s): Both.

Criteria:

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

Starting date: October 2002
Ending date: September 2005
Last updated: March 21, 2008