Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer; Drug: Budesonide/formoterol pMDI 40/2.25 ug

Study type: Interventional

Funder types: Industry

Identifiers

NCT00536913

D5897C00004

Details and patient eligibility

About

The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).

Enrollment: 107 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children 6-11 years, diagnosed asthma treated
• 6 months, PEF
• 50% of predicted normal value pre-bronchodilator

Exclusion criteria

• current systemic glucocorticosteroids usage
• current respiratory infection
• any significant disease or disorder as judged by investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

With Spacer

Experimental group

Description:

Budesonide/formoterol pMDI 40/2.25ug + spacer

Treatment:

Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer

Without Spacer

Experimental group

Description:

Budesonide/formoterol pMDI 40/2.25 ug

Treatment:

Drug: Budesonide/formoterol pMDI 40/2.25 ug