Overview

Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5

Status:
Completed
Trial end date:
2004-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents 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 12 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:

- Has required treatment with 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