Titratable Dosing in Moderate to Severe Asthmatics

Verified by: AstraZeneca, January 2011
First Received: April 1, 2008 | Last Updated: January 21, 2011 | Phase: Phase 3 | Start Date: August 2003
Overall Status: Completed | Estimated Enrollment: 570
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The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma...

Brief Summary

Official Title: “A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma”

The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.

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

Intervention(s) in this Clinical Trial

  • Drug: budesonide/formoterol
  • Drug: Symbicort pMDI + budesonide HFA pMDI
    • Symbicort 2 X 160/4.5mcg & budesonide HFA pMDI 4 X 160mcg

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Sham Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments.
    • Time Frame: 7 assessments within 12 month treatment period

Secondary Measures

  • To measure changes in lung function tests, patient reported outcomes and usage of medical resource
    • Time Frame: 7 assessments within 12 month treatment period
  • Blood levels of budesonide and formoterol
    • Time Frame: 10 blood samples taken at 1 visit in a sub-set of patients

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol
  • Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

  • Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.
  • Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.

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/NCT00651768

Study ID Number: SD-039-0728

ClinicalTrials.gov Identifier: NCT00651768

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00651768