Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00652002
First received: April 1, 2008
Last updated: January 21, 2011
Last verified: January 2011

April 1, 2008
January 21, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00652002
SD-039-0717, D5896C00717
No
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