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
Sponsor study identifier
Secondary identifiers
interventional
450
0 countries
N/A
Study Start
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
January 2004
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2004
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
January 2004
Actual (reported)April 1, 2008
Actual (reported)April 3, 2008
Actual (reported)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
Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments
Throughout the treatment period
budesonide
formoterol
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
budesonide/formoterol
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordTashkin DP, Moore GE, Trudo F, DePietro M, Chipps BE. Assessment of Consistency of Fixed Airflow Obstruction Status during Budesonide/Formoterol Treatment and Its Effects on Treatment Outcomes in Patients with Asthma. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):705-12. doi: 10.1016/j.jaip.2016.02.014. Epub 2016 Mar 30.
Tashkin DP, Chipps BE, Trudo F, Zangrilli JG. Fixed airflow obstruction in asthma: a descriptive study of patient profiles and effect on treatment responses. J Asthma. 2014 Aug;51(6):603-9. doi: 10.3109/02770903.2014.895012. Epub 2014 Mar 19.
Catherine Bonuccelli
AstraZeneca
First Submitted
April 1, 2008
First Posted
April 3, 2008
Study Start
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
January 2004
Actual (reported)Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
Last Updated
January 24, 2011
Record last verified: 2011-01
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Source: ClinicalTrials.gov.
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