Overview

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

Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Formoterol Fumarate
Criteria
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