Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5

Condition(s) targeted: Asthma

Intervention: budesonide/formoterol (Drug); budesonide (Drug); formoterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Catherine Bonuccelli, Study Director, Affiliation: AstraZeneca

The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults

Official title: A 12 Week Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Children (at Least 6years of Age) and Adults With Asthma-SPRUCE 80/4.5

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation

Secondary outcome: Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments

Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.

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

Starting date: August 2002
Ending date: December 2003
Last updated: April 2, 2008