Overview

Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5

Status:
Completed
Trial end date:
2003-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Formoterol Fumarate
Criteria
Inclusion Criteria:

- At least 6 years of age

- Diagnosis of asthma

- Baseline lung function test results as determined by protocol and required and
received treatment with inhaled corticosteroids and/or lung treatments specified in
protocol within the timeframe and doses specified in the protocol

Exclusion Criteria:

- Severe asthma

- Has required treatment with any non-inhaled corticosteroids within previous 4 weeks,
has sensitivity to drugs specified in the protocol or requires treatment with
beta-blockers

- Had cancer within previous 5 years or currently has any other significant disease or
disorder as judged by the investigator