Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Budesonide inhalation suspension; Drug: Montelukast Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00641472

D5257L00750

DX-RES-2103

Details and patient eligibility

About

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.

Enrollment: 380 estimated patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

1

Experimental group

Description:

Budesonide inhalation suspension

Treatment:

Drug: Budesonide inhalation suspension

2

Active Comparator group

Description:

Montelukast sodium

Treatment:

Drug: Montelukast Sodium