Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5

Verified by: AstraZeneca, January 2011
First Received: April 1, 2008 | Last Updated: January 21, 2011 | Phase: Phase 3 | Start Date: July 2002
Overall Status: Completed | Estimated Enrollment: 450
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The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and...

Brief Summary

Official Title: “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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: budesonide/formoterol
  • Drug: budesonide
  • Drug: formoterol

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2
    • budesonide
  • Active Comparator: 3
    • formoterol

Outcome Measures for this Clinical Trial

Primary Measures

  • 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

Secondary Measures

  • Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments
    • Time Frame: Throughout the treatment period

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Catherine Bonuccelli Study Director AstraZeneca  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00652002

Study ID Number: SD-039-0717

ClinicalTrials.gov Identifier: NCT00652002

Health Authority: United States: Food and Drug Administration

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