We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5

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.
ClinicalTrials.gov Identifier: NCT00652002
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : January 24, 2011
Information provided by:

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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Drug: budesonide/formoterol
    Other Name: Symbicort
  • Drug: budesonide
  • Drug: formoterol
  • Experimental: 1
    Intervention: Drug: budesonide/formoterol
  • Active Comparator: 2
    Intervention: Drug: budesonide
  • Active Comparator: 3
    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.
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)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Study Director: Catherine Bonuccelli AstraZeneca
January 2011

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