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Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652002
First Posted: April 3, 2008
Last Update Posted: January 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
April 1, 2008
April 3, 2008
January 24, 2011
July 2002
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00652002 on ClinicalTrials.gov Archive Site
Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments [ Time Frame: Throughout the treatment period ]
Same as current
Not Provided
Not Provided
 
Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5
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 Adolescents (at Least 12 Years of Age) and Adults With Asthma - SPRUCE 160/4.5
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: budesonide/formoterol
    Other Name: Symbicort
  • Drug: budesonide
  • Drug: formoterol
  • Experimental: 1
    Intervention: Drug: budesonide/formoterol
  • Active Comparator: 2
    budesonide
    Intervention: Drug: budesonide
  • Active Comparator: 3
    formoterol
    Intervention: Drug: formoterol
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. Erratum in: Drugs R D. 2012 Mar 1;12(1):15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
January 2004
Not Provided

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00652002
SD-039-0717
D5896C00717
No
Not Provided
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Catherine Bonuccelli AstraZeneca
AstraZeneca
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP