NCT00652002CompletedPhase 3
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 Adolescents (at Least 12 Years of Age) and Adults With Asthma - SPRUCE 160/4.5
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 450
- Primary Endpoint
- 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Intervention: budesonide/formoterol (Drug)
2
Active Comparator
budesonide
Intervention: budesonide (Drug)
3
Active Comparator
formoterol
Intervention: formoterol (Drug)
Outcomes
Primary Outcomes
12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation
Time Frame: FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period
Secondary Outcomes
- Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments(Throughout the treatment period)
Investigators
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