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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2004

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

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
    

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

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Catherine Bonuccelli Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on August 29, 2008

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