Adults With Moderate to Severe Asthma

Verified by: AstraZeneca, January 2011
First Received: March 18, 2008 | Last Updated: January 21, 2011 | Phase: Phase 3 | Start Date: April 2003
Overall Status: Completed | Estimated Enrollment: 900
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A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above...

Brief Summary

Official Title: “A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.”

A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
  • Study Primary Completion Date: December 2004

Intervention(s) in this Clinical Trial

  • Drug: Budesonide
    • 0.5mg once daily
  • Drug: Budesonide
    • 1mg once daily
  • Drug: Budesonide
    • 1mg twice daily
  • Drug: Budesonide
    • 2mg once daily
  • Drug: Budesonide
    • 4.00mcg twice daily

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Pulmicort RESPULES
  • Experimental: 2
    • Pulmicort TURBUHALER

Outcome Measures for this Clinical Trial

Primary Measures

  • Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.
    • Time Frame: Day -14, 1, and every 28 days thereafter

Secondary Measures

  • Percentage of symptom free days
    • Time Frame: Day -14, 1, and every 28 days thereafter
  • Percentage of symptom free nights
    • Time Frame: Day -14, 1, and every 28 days thereafter
  • Percentage of symptom free 24-hours
    • Time Frame: Day -14, 1, and every 28 days thereafter

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Male or female aged 12 or over who have asthma
  • Ability to properly use an electronic diary
  • Able and willing to nebulize for up to 20 minutes every morning and evening

Exclusion Criteria:

  • Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
  • Planned hospitalisation during the study
  • pregnant women or women planning to become pregnant

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

Bertil Andersson Study Director AstraZeneca  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642122

Study ID Number: SD-004-0764

ClinicalTrials.gov Identifier: NCT00642122

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00642122