Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5
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
2 other identifiers
interventional
450
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Aug 2002
Shorter than P25 for phase_3 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 3, 2008
CompletedJanuary 24, 2011
January 1, 2011
April 1, 2008
January 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation
FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period
Secondary Outcomes (1)
Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments
Throughout the treatment period
Study Arms (3)
1
EXPERIMENTALSymbicort
2
ACTIVE COMPARATORbudesonide
3
ACTIVE COMPARATORformoterol
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Related Publications (1)
Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
PMID: 22329608DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Catherine Bonuccelli
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 1, 2008
First Posted
April 3, 2008
Study Start
August 1, 2002
Study Completion
September 1, 2003
Last Updated
January 24, 2011
Record last verified: 2011-01